Colorectal CancerNCT06042816
Analgesic Efficacy of Free-opioid Anesthesia for Colorectal Surgery
A study testing Free-opioid anesthesia and opioid anesthesia in people with Colorectal Cancer, run by Vietnam Military Medical University at 1 site in Vietnam.
Trial summary
Objectives: To compare free-opioid anesthesia (the combination of epidural anesthesia, intravenous lidocaine, ketamine, propofol, and sevoflurane) and opioid anesthesia (fentanyl, propofol and sevoflurane) regarding intraoperative analgesic efficacy in colectomies and rectal resections at Viet Tiep Friendship… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Free-opioid anesthesia and opioid anesthesia
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteVietnam
- Study dates
- 30 Dec 2019to 30 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients agreed to participate in the study.
- Patients aged ≥ 18 years old,
- Those who underwent elective colectomies or rectal resections,
- Those who were ASA (American Society of Anesthesiologists) classified as I - III,
- Those who were indicated for general endotracheal anesthesia from December 2019 to November 2021 at Viet Tiep Friendship Hospital
Who cannot join
- Patients refused to participate in the study,
- Patients had BMI (Body Mass Index) ≥ 35;
- Pregnant or lactating or menstruating women;
- Those who had liver failure, renal failure, heart failure, history of chronic pain, alcohol or drug abuse, mental illnesses, allergies or contraindications to any studied medications.
- Those who were unable to assess pain or use of patient-controlled analgesia devices (PCA).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Analgesic Efficacy of Free Opioid Anesthesia for Patients Undergoing Colectomies and Rectal Resections: A Prospective, Randomized Controlled Clinical Trial
Objectives: To compare free-opioid anesthesia (the combination of epidural anesthesia, intravenous lidocaine, ketamine, propofol, and sevoflurane) and opioid anesthesia (fentanyl, propofol and sevoflurane) regarding intraoperative analgesic efficacy in colectomies and rectal resections at Viet Tiep Friendship Hospital.
Methods: A prospective, randomized controlled clinical trial was performed on 98 patients who were anesthetized for colorectal surgery from December 2019 to November 2021. Patients were randomized into 2 groups: Group OA - Opioid anesthesia (n = 49): Intraoperative pain control by fentanyl; FOA group - Free-opioid anesthesia (n = 49): Intraoperative pain control by continuous infusion of lidocaine, bolus doses of ketamine combined with epidural levobupivacaine.
Read the detailed description
After being placed an epidural catheter and given a bolus dose of dexamethasone 0.1 mg/kg, patients was endotracheal anesthetized with propofol 1% 2-2.5 mg/kg, rocuronium 0.6 mg/kg. Intubation was implemented when TOF (Train Of Four)=0 and RE (Response Entropy), SE (State Entropy) ≤ 60. Patients in OA group received a bolus dose of fentanyl 2 µg/kg before induction of anesthesia while those in FOA group received bolus doses of lidocaine 1 mg/kg and ketamine 0.5 mg/kg. In FOA group, lidocaine 10% was sprayed on the patients glottis to facilitate intubation.
For anesthesia maintenance, in group OA, a bolus dose of fentanyl 3 µg/kg was given 5 minutes before skin incision, and then a continuous infusion of fentanyl 2 µg/kg/h was maintained for intraoperative pain management; fentanyl 0.5 μg/kg was bolused when SPI (Surgical Pleth Index) > 50, 40 < SE < 60, TOF = 0 and the patient was hemodynamically stable. Propofol and fentanyl were discontinued at the start of skin closure. In FOA group, patients received intraoperative multimodal analgesia, in which an epidural bolus of 3 - 5 ml of levobupivacaine 0.1% was followed by a continuous infusion of 3 - 5 ml/h epidurally; in addition, intravenous infusion of lidocaine 1 mg/kg/hour and ketamine 0.25 mg/kg/h were maintained until the end of surgery. Patients were given a bolus of 3-5 ml levobupivacaine 0.1% epidurally and ketamine 0.25 mg/kg intravenously if SPI > 50, 40 < SE < 60, TOF = 0 and hemodynamics was stable.
For all patients, anesthesia was maintained by volatile anesthetics (Sevoflurane or Desflurane) to ensure 40 < SE < 60, and rocuronium 0.2 mg/kg was repeated when TOF = 2 (the last injection of neuromuscular blockade was not given when the estimated duration from the point of injection to the point of abdominal closure is shorter than 20 minutes). Mechanical ventilation was provided with a tidal volume 6-8 ml/kg in the volume-controlled mode and respiratory rate at 10-12 breath/minute, FiO2 (Fraction of inspired oxygen)=50%. Peak airway pressure was maintained within the range of 12-16 cmH2O and EtCO2 (End-tidal Carbon dioxide) was kept from 35 to 40 mmHg with a fresh gas flow of 1.2 - 2 liters/minute. At the end of surgery, reversal of neuromuscular blockade was performed with neostigmine combined with atropine, and extubation was carried out when patients met the criteria. Postoperative pain management was implemented with patient-controlled epidural levobupivacaine 0.1% for 72 hours, and pain rescue with fentanyl 0.5 μg/kg.
- Conditions
- Colorectal Cancer
- Being tested
- Free-opioid anesthesia, opioid anesthesia
- Keywords
- Free-opioid anesthesia, Opioid anesthesia, colorectal surgery
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Free-opioid anesthesiaProcedure or surgery
Free opioid anesthesia (FOA) has been used in many countries around the world, making use of multimodal analgesia therapy which includes hypnotics, N-methyl-D-aspartate (NMDA) antagonists, local anesthetics and anti-inflammatory agents and sympathetic block in surgery. This method was demonstrated to contribute to enhanced recovery after surgery (ERAS). The use of long-acting local anesthetics also enhances postoperative pain relief. As a result, the concept of balanced anesthesia now has a change in three basic components: hypnotics, muscle relaxants and sympathomimetic inhibitors
opioid anesthesiaProcedure or surgery
Opioids have been used as one of three basic components of balanced anesthesia, including anesthetic drugs, pain relievers, and neuromuscular blockade agents (opioid anesthesia). Opioids not only facilitate deep anesthesia but also create the most favorable conditions for surgeries. Fentanyl is a potent opioid used to control pain, reduce the dose of sympathomimetic inhibitors and maintain hemodynamic stability. However, several common side effects of fentanyl are well known: nausea and vomiting, constipation, urinary retention, headache, pruritus, rash, histamine release, biliary spasm and respiratory depression, the most severe adverse effect
| Study group | Role | What they receive |
|---|---|---|
| Free-opioid anesthesia | Experimental | 49 patients were injected bolus doses of lidocaine 1 mg/kg and ketamine 0.5 mg/kg before induction. Then intravenous propofol 1% 2-2.5 mg/kg, rocuronium 0.6 mg/kg were utilized for induction. For anesthesia maintenance, patients received intraoperative multimodal analgesia, in which an epidural bolus of 3 - 5 ml of levobupivacaine 0.1% was followed by a continuous infusion of 3 - 5 ml/h epidurally; in addition, intravenous infusion of lidocaine 1 mg/kg/hour and ketamine 0.25 mg/kg/h were maintained until the end of surgery. Patients were given a bolus of 3-5 ml levobupivacaine 0.1% epidurally and ketamine 0.25 mg/kg intravenously if SPI > 50, 40 < SE < 60, TOF = 0 and hemodynamics was stable. Postoperative pain management was implemented with patient-controlled epidural levobupivacaine 0.1% for 72 hours, and pain rescue with fentanyl 0.5 μg/kg. Receives: Procedure: Free-opioid anesthesia |
| Opioid anesthesia | Active comparator | 49 patients received a bolus dose of fentanyl 2 µg/kg before induction of anesthesia. For anesthesia maintenance, in group OA, a bolus dose of fentanyl 3 µg/kg was given 5 minutes before skin incision, and then a continuous infusion of fentanyl 2 µg/kg/h was maintained for intraoperative pain management; fentanyl 0.5 μg/kg was bolused when SPI (Surgical Pleth Index) > 50, 40 < State Entropy (SE) < 60, Train of four (TOF) = 0 and the patient was hemodynamically stable. Propofol and fentanyl were discontinued at the start of skin closure. Postoperative pain management was implemented with patient-controlled epidural levobupivacaine 0.1% for 72 hours, and pain rescue with fentanyl 0.5 μg/kg. Receives: Procedure: opioid anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
analgesic efficacy of free-opioid anesthesia
intraoperative alteration of Surgical Pleth Index (SPI). The Surgical Pleth Index (SPI) is an objective tool that can reflect nociception-antinociception balance and guide the use of intraoperative analgesics. The values of the SPI range from 0 to 100. During general anaesthesia, maintaining a value between 20 and 50 is generally recommended. When the SPI value is greater than 50 and exceeds 3-5 min, it routinely indicates that the noxious stimulation is too strong and that additional analgesic drugs are needed.
Measured: before induction of anesthesia
analgesic efficacy of free-opioid anesthesia
intraoperative alteration of Surgical Pleth Index (SPI)
Measured: After intubation
analgesic efficacy of free-opioid anesthesia
intraoperative alteration of Surgical Pleth Index (SPI)
Measured: After skin incision
analgesic efficacy of free-opioid anesthesia
intraoperative alteration of Surgical Pleth Index (SPI)
Measured: when the restoration of eyelids reflex emerged
analgesic efficacy of free-opioid anesthesia
The number of times of intraoperative analgesics adjustment
Measured: Intraoperatively (From the induction of anesthesia to the emergence)
analgesic efficacy of free-opioid anesthesia
the proportion of patients requiring postoperative pain rescue
Measured: postoperatively (upto 3 days after surgery)
Secondary outcomes (39)
Effects of free-opioid anesthesia on intraoperative mean arterial blood pressure
Non-invasive blood pressure was assessed every 5 minutes intraoperatively and recorded at some investigated time points. The mean arterial blood pressure at each time point was compared between the two groups.
Measured: T0 (right after entering the operating theatre)
Effects of free-opioid anesthesia on intraoperative mean arterial blood pressure
Non-invasive blood pressure was assessed every 5 minutes intraoperatively and recorded at some investigated time points. The mean arterial blood pressure at each time point was compared between the two groups.
Measured: T1 (before induction of anesthesia)
Effects of free-opioid anesthesia on intraoperative mean arterial blood pressure
Non-invasive blood pressure was assessed every 5 minutes intraoperatively and recorded at some investigated time points. The mean arterial blood pressure at each time point was compared between the two groups.
Measured: T2 (patients lost eyelid reflex and response to verbal command)
Effects of free-opioid anesthesia on intraoperative mean arterial blood pressure
Non-invasive blood pressure was assessed every 5 minutes intraoperatively and recorded at some investigated time points. The mean arterial blood pressure at each time point was compared between the two groups.
Measured: T3 (before intubation)
Effects of free-opioid anesthesia on intraoperative mean arterial blood pressure
Non-invasive blood pressure was assessed every 5 minutes intraoperatively and recorded at some investigated time points. The mean arterial blood pressure at each time point was compared between the two groups.
Measured: T4 (after intubation)
Effects of free-opioid anesthesia on intraoperative mean arterial blood pressure
Non-invasive blood pressure was assessed every 5 minutes intraoperatively and recorded at some investigated time points. The mean arterial blood pressure at each time point was compared between the two groups.
Measured: T5 (before skin incision)
Effects of free-opioid anesthesia on intraoperative mean arterial blood pressure
Non-invasive blood pressure was assessed every 5 minutes intraoperatively and recorded at some investigated time points. The mean arterial blood pressure at each time point was compared between the two groups.
Measured: T6 (after skin incision)
Effects of free-opioid anesthesia on intraoperative mean arterial blood pressure
Non-invasive blood pressure was assessed every 5 minutes intraoperatively and recorded at some investigated time points. The mean arterial blood pressure at each time point was compared between the two groups.
Measured: T7 (colon release)
Effects of free-opioid anesthesia on intraoperative mean arterial blood pressure
Non-invasive blood pressure was assessed every 5 minutes intraoperatively and recorded at some investigated time points. The mean arterial blood pressure at each time point was compared between the two groups.
Measured: T8 (dissection of colorectal mesentery)
Effects of free-opioid anesthesia on intraoperative mean arterial blood pressure
Non-invasive blood pressure was assessed every 5 minutes intraoperatively and recorded at some investigated time points. The mean arterial blood pressure at each time point was compared between the two groups.
Measured: T9 (colon resection)
Effects of free-opioid anesthesia on intraoperative mean arterial blood pressure
Non-invasive blood pressure was assessed every 5 minutes intraoperatively and recorded at some investigated time points. The mean arterial blood pressure at each time point was compared between the two groups.
Measured: T10 (restore gastrointestinal flow)
Effects of free-opioid anesthesia on intraoperative mean arterial blood pressure
Non-invasive blood pressure was assessed every 5 minutes intraoperatively and recorded at some investigated time points. The mean arterial blood pressure at each time point was compared between the two groups.
Measured: T11 (drainage placement)
Effects of free-opioid anesthesia on intraoperative mean arterial blood pressure
Non-invasive blood pressure was assessed every 5 minutes intraoperatively and recorded at some investigated time points. The mean arterial blood pressure at each time point was compared between the two groups.
Measured: T12 (before skin closure)
Effects of free-opioid anesthesia on intraoperative mean arterial blood pressure
Non-invasive blood pressure was assessed every 5 minutes intraoperatively and recorded at some investigated time points. The mean arterial blood pressure at each time point was compared between the two groups.
Measured: T13 (immediately after skin closure)
Effects of free-opioid anesthesia on intraoperative mean arterial blood pressure
Non-invasive blood pressure was assessed every 5 minutes intraoperatively and recorded at some investigated time points. The mean arterial blood pressure at each time point was compared between the two groups.
Measured: T14 (eyelids reflex restored and patients eyes could open on command)
Effects of free-opioid anesthesia on intraoperative mean arterial blood pressure
Non-invasive blood pressure was assessed every 5 minutes intraoperatively and recorded at some investigated time points. The mean arterial blood pressure at each time point was compared between the two groups.
Measured: T15 (before extubation)
Effects of free-opioid anesthesia on intraoperative mean arterial blood pressure
Non-invasive blood pressure was assessed every 5 minutes intraoperatively and recorded at some investigated time points. The mean arterial blood pressure at each time point was compared between the two groups.
Measured: T16 (15 minutes after extubation)
Effects of free-opioid anesthesia on intraoperative heart rate
Heart rate was assessed every 5 minutes intraoperatively and recorded at some investigated time points. The heart rate at each time point was compared between the two groups.
Measured: T0 (right after entering the operating theatre)
Effects of free-opioid anesthesia on intraoperative heart rate
Heart rate was assessed every 5 minutes intraoperatively and recorded at some investigated time points. The heart rate at each time point was compared between the two groups.
Measured: T1 (before induction of anesthesia)
Effects of free-opioid anesthesia on intraoperative heart rate
Heart rate was assessed every 5 minutes intraoperatively and recorded at some investigated time points. The heart rate at each time point was compared between the two groups.
Measured: T2 (patients lost eyelid reflex and response to verbal command)
Effects of free-opioid anesthesia on intraoperative heart rate
Heart rate was assessed every 5 minutes intraoperatively and recorded at some investigated time points. The heart rate at each time point was compared between the two groups.
Measured: T3 (before intubation)
Effects of free-opioid anesthesia on intraoperative heart rate
Heart rate was assessed every 5 minutes intraoperatively and recorded at some investigated time points. The heart rate at each time point was compared between the two groups.
Measured: T4 (after intubation)
Effects of free-opioid anesthesia on intraoperative heart rate
Heart rate was assessed every 5 minutes intraoperatively and recorded at some investigated time points. The heart rate at each time point was compared between the two groups.
Measured: T5 (before skin incision)
Effects of free-opioid anesthesia on intraoperative heart rate
Heart rate was assessed every 5 minutes intraoperatively and recorded at some investigated time points. The heart rate at each time point was compared between the two groups.
Measured: T6 (after skin incision)
Effects of free-opioid anesthesia on intraoperative heart rate
Heart rate was assessed every 5 minutes intraoperatively and recorded at some investigated time points. The heart rate at each time point was compared between the two groups.
Measured: T7 (colon release)
Effects of free-opioid anesthesia on intraoperative heart rate
Heart rate was assessed every 5 minutes intraoperatively and recorded at some investigated time points. The heart rate at each time point was compared between the two groups.
Measured: T8 (dissection of colorectal mesentery)
Effects of free-opioid anesthesia on intraoperative heart rate
Heart rate was assessed every 5 minutes intraoperatively and recorded at some investigated time points. The heart rate at each time point was compared between the two groups.
Measured: T9 (colon resection)
Effects of free-opioid anesthesia on intraoperative heart rate
Heart rate was assessed every 5 minutes intraoperatively and recorded at some investigated time points. The heart rate at each time point was compared between the two groups.
Measured: T10 (restore gastrointestinal flow)
Effects of free-opioid anesthesia on intraoperative heart rate
Heart rate was assessed every 5 minutes intraoperatively and recorded at some investigated time points. The heart rate at each time point was compared between the two groups.
Measured: T11 (drainage placement)
Effects of free-opioid anesthesia on intraoperative heart rate
Heart rate was assessed every 5 minutes intraoperatively and recorded at some investigated time points. The heart rate at each time point was compared between the two groups.
Measured: T12 (before skin closure)
Effects of free-opioid anesthesia on intraoperative heart rate
Heart rate was assessed every 5 minutes intraoperatively and recorded at some investigated time points. The heart rate at each time point was compared between the two groups.
Measured: T13 (immediately after skin closure)
Effects of free-opioid anesthesia on intraoperative heart rate
Heart rate was assessed every 5 minutes intraoperatively and recorded at some investigated time points. The heart rate at each time point was compared between the two groups.
Measured: T14 (eyelids reflex restored and patients eyes could open on command)
Effects of free-opioid anesthesia on intraoperative heart rate
Heart rate was assessed every 5 minutes intraoperatively and recorded at some investigated time points. The heart rate at each time point was compared between the two groups.
Measured: T15 (before extubation)
Effects of free-opioid anesthesia on intraoperative heart rate
Heart rate was assessed every 5 minutes intraoperatively and recorded at some investigated time points. The heart rate at each time point was compared between the two groups.
Measured: T16 (15 minutes after extubation)
changes in the concentration of IL (Interleukin)-6
Blood samples were collected in a heparin tube immediately before surgery (T0) and 1 hour after extubation. They were centrifuged, and then plasma was separated and stored at -70°C until being analyzed. IL-6 levels were analyzed using enzyme-linked immunosorbent assay (ELISA). Changes in IL-6 were recorded and compared between the two groups
Measured: Before surgery
changes in the concentration of IL (Interleukin)-6
Blood samples were collected in a heparin tube immediately before surgery (T0) and 1 hour after extubation. They were centrifuged, and then plasma was separated and stored at -70°C until being analyzed. IL-6 levels were analyzed using enzyme-linked immunosorbent assay (ELISA). Changes in IL-6 were recorded and compared between the two groups
Measured: 1 hour after surgery
changes in the concentration of IL-10
Blood samples were collected in a heparin tube immediately before surgery (T0) and 1 hour after extubation. They were centrifuged, and then plasma was separated and stored at -70°C until being analyzed. IL-10 levels were analyzed using enzyme-linked immunosorbent assay (ELISA). Changes in IL-10 were recorded and compared between the two groups
Measured: Before surgery
changes in the concentration of IL-10
Blood samples were collected in a heparin tube immediately before surgery (T0) and 1 hour after extubation. They were centrifuged, and then plasma was separated and stored at -70°C until being analyzed. IL-10 levels were analyzed using enzyme-linked immunosorbent assay (ELISA). Changes in IL-10 were recorded and compared between the two groups
Measured: 1 hour after surgery
Adverse effects of free-opioid anesthesia
the rate of patients suffering nausea and vomiting
Measured: up to 3 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start30 Dec 2019
- Primary completion30 Dec 2021
- Study completion30 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients were randomized into 2 groups: Group OA - Opioid anesthesia (n = 49): Intraoperative pain control by fentanyl; FOA group - Free-opioid anesthesia (n = 49): Intraoperative pain control by continuous infusion of lidocaine, bolus doses of ketamine combined with epidural levobupivacaine.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vietnam Military Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nguyen Trung Kien, Vietnam Military Medical University
- Investigators
- Kien T Nguyen, Ph.D, Study director, Center of Emergency, Critical Care Medicine and Clinical Toxicology, Military Hospital 103, Vietnam
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06042816
- Sponsor's protocol ID
- 01/CN-HDĐ
- Status last verified
- Sep 2023
- First submitted
- 5 Sep 2023
- Last updated
- 21 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The datasets used and/or analyzed during this study are available from the corresponding author on reasonable request. Researchers could contact the corresponding author via email to ask for IPD.
Publications
Vaswani JP, Debata D, Vyas V, Pattil S. Comparative Study of the Effect of Dexmedetomidine Vs. Fentanyl on Haemodynamic Response in Patients Undergoing Elective Laparoscopic Surgery. J Clin Diagn Res. 2017 Sep;11(9):UC04-UC08. doi: 10.7860/JCDR/2017/27020.10578. Epub 2017 Sep 1.
PubMed 29207810Choi H, Song JY, Oh EJ, Chae MS, Yu S, Moon YE. The Effect of Opioid-Free Anesthesia on the Quality of Recovery After Gynecological Laparoscopy: A Prospective Randomized Controlled Trial. J Pain Res. 2022 Aug 3;15:2197-2209. doi: 10.2147/JPR.S373412. eCollection 2022.
PubMed 35945992Bakan M, Umutoglu T, Topuz U, Uysal H, Bayram M, Kadioglu H, Salihoglu Z. Opioid-free total intravenous anesthesia with propofol, dexmedetomidine and lidocaine infusions for laparoscopic cholecystectomy: a prospective, randomized, double-blinded study. Braz J Anesthesiol. 2015 May-Jun;65(3):191-9. doi: 10.1016/j.bjane.2014.05.001. Epub 2014 Jun 3.
PubMed 25925031Hakim KYK, Wahba WZB. Opioid-Free Total Intravenous Anesthesia Improves Postoperative Quality of Recovery after Ambulatory Gynecologic Laparoscopy. Anesth Essays Res. 2019 Apr-Jun;13(2):199-203. doi: 10.4103/aer.AER_74_19.
PubMed 31198230Chin KJ, Lewis S. Opioid-free Analgesia for Posterior Spinal Fusion Surgery Using Erector Spinae Plane (ESP) Blocks in a Multimodal Anesthetic Regimen. Spine (Phila Pa 1976). 2019 Mar 15;44(6):E379-E383. doi: 10.1097/BRS.0000000000002855.
PubMed 30180150
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Analgesic Efficacy of Free Opioid Anesthesia for Patients Undergoing Colectomies and Rectal Resections: A Prospective, Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06042816
- Acronym / sponsor ID
- 01/CN-HDĐ
- Conditions
- Colorectal Cancer
- Keywords
- Free-opioid anesthesia, Opioid anesthesia, colorectal surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Vietnam Military Medical UniversityUniversity, hospital or other
- Study start
- 30 Dec 2019 (actual)
- Primary completion
- 30 Dec 2021 (actual)
- Study completion
- 30 Dec 2021 (actual)
- First posted
- 21 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Objectives: To compare free-opioid anesthesia (the combination of epidural anesthesia, intravenous lidocaine, ketamine, propofol, and sevoflurane) and opioid anesthesia (fentanyl, propofol and sevoflurane) regarding intraoperative analgesic efficacy in colectomies and rectal resections at Viet Tiep Friendship Hospital.
Methods: A prospective, randomized controlled clinical trial was performed on 98 patients who were anesthetized for colorectal surgery from December 2019 to November 2021. Patients were randomized into 2 groups: Group OA - Opioid anesthesia (n = 49): Intraoperative pain control by fentanyl; FOA group - Free-opioid anesthesia (n = 49): Intraoperative pain control by continuous infusion of lidocaine, bolus doses of ketamine combined with epidural levobupivacaine.
Detailed description
After being placed an epidural catheter and given a bolus dose of dexamethasone 0.1 mg/kg, patients was endotracheal anesthetized with propofol 1% 2-2.5 mg/kg, rocuronium 0.6 mg/kg. Intubation was implemented when TOF (Train Of Four)=0 and RE (Response Entropy), SE (State Entropy) ≤ 60. Patients in OA group received a bolus dose of fentanyl 2 µg/kg before induction of anesthesia while those in FOA group received bolus doses of lidocaine 1 mg/kg and ketamine 0.5 mg/kg. In FOA group, lidocaine 10% was sprayed on the patients glottis to facilitate intubation.
For anesthesia maintenance, in group OA, a bolus dose of fentanyl 3 µg/kg was given 5 minutes before skin incision, and then a continuous infusion of fentanyl 2 µg/kg/h was maintained for intraoperative pain management; fentanyl 0.5 μg/kg was bolused when SPI (Surgical Pleth Index) > 50, 40 < SE < 60, TOF = 0 and the patient was hemodynamically stable. Propofol and fentanyl were discontinued at the start of skin closure. In FOA group, patients received intraoperative multimodal analgesia, in which an epidural bolus of 3 - 5 ml of levobupivacaine 0.1% was followed by a continuous infusion of 3 - 5 ml/h epidurally; in addition, intravenous infusion of lidocaine 1 mg/kg/hour and ketamine 0.25 mg/kg/h were maintained until the end of surgery. Patients were given a bolus of 3-5 ml levobupivacaine 0.1% epidurally and ketamine 0.25 mg/kg intravenously if SPI > 50, 40 < SE < 60, TOF = 0 and hemodynamics was stable.
For all patients, anesthesia was maintained by volatile anesthetics (Sevoflurane or Desflurane) to ensure 40 < SE < 60, and rocuronium 0.2 mg/kg was repeated when TOF = 2 (the last injection of neuromuscular blockade was not given when the estimated duration from the point of injection to the point of abdominal closure is shorter than 20 minutes). Mechanical ventilation was provided with a tidal volume 6-8 ml/kg in the volume-controlled mode and respiratory rate at 10-12 breath/minute, FiO2 (Fraction of inspired oxygen)=50%. Peak airway pressure was maintained within the range of 12-16 cmH2O and EtCO2 (End-tidal Carbon dioxide) was kept from 35 to 40 mmHg with a fresh gas flow of 1.2 - 2 liters/minute. At the end of surgery, reversal of neuromuscular blockade was performed with neostigmine combined with atropine, and extubation was carried out when patients met the criteria. Postoperative pain management was implemented with patient-controlled epidural levobupivacaine 0.1% for 72 hours, and pain rescue with fentanyl 0.5 μg/kg.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients were randomized into 2 groups: Group OA - Opioid anesthesia (n = 49): Intraoperative pain control by fentanyl; FOA group - Free-opioid anesthesia (n = 49): Intraoperative pain control by continuous infusion of lidocaine, bolus doses of ketamine combined with epidural levobupivacaine.
| Arm | Type | Receives |
|---|---|---|
| Free-opioid anesthesia | Experimental | Procedure: Free-opioid anesthesia49 patients were injected bolus doses of lidocaine 1 mg/kg and ketamine 0.5 mg/kg before induction. Then intravenous propofol 1% 2-2.5 mg/kg, rocuronium 0.6 mg/kg were utilized for induction. For anesthesia maintenance, patients received intraoperative multimodal analgesia, in which an epidural bolus of 3 - 5 ml of levobupivacaine 0.1% was followed by a continuous infusion of 3 - 5 ml/h epidurally; in addition, intravenous infusion of lidocaine 1 mg/kg/hour and ketamine 0.25 mg/kg/h were maintained until the end of surgery. Patients were given a bolus of 3-5 ml levobupivacaine 0.1% epidurally and ketamine 0.25 mg/kg intravenously if SPI > 50, 40 < SE < 60, TOF = 0 and hemodynamics was stable. Postoperative pain management was implemented with patient-controlled epidural levobupivacaine 0.1% for 72 hours, and pain rescue with fentanyl 0.5 μg/kg. |
| Opioid anesthesia | Active comparator | Procedure: opioid anesthesia49 patients received a bolus dose of fentanyl 2 µg/kg before induction of anesthesia. For anesthesia maintenance, in group OA, a bolus dose of fentanyl 3 µg/kg was given 5 minutes before skin incision, and then a continuous infusion of fentanyl 2 µg/kg/h was maintained for intraoperative pain management; fentanyl 0.5 μg/kg was bolused when SPI (Surgical Pleth Index) > 50, 40 < State Entropy (SE) < 60, Train of four (TOF) = 0 and the patient was hemodynamically stable. Propofol and fentanyl were discontinued at the start of skin closure. Postoperative pain management was implemented with patient-controlled epidural levobupivacaine 0.1% for 72 hours, and pain rescue with fentanyl 0.5 μg/kg. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients agreed to participate in the study.
- Patients aged ≥ 18 years old,
- Those who underwent elective colectomies or rectal resections,
- Those who were ASA (American Society of Anesthesiologists) classified as I - III,
- Those who were indicated for general endotracheal anesthesia from December 2019 to November 2021 at Viet Tiep Friendship Hospital
Key exclusion criteria (5 listed)
- Patients refused to participate in the study,
- Patients had BMI (Body Mass Index) ≥ 35;
- Pregnant or lactating or menstruating women;
- Those who had liver failure, renal failure, heart failure, history of chronic pain, alcohol or drug abuse, mental illnesses, allergies or contraindications to any studied medications.
- Those who were unable to assess pain or use of patient-controlled analgesia devices (PCA).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Free-opioid anesthesiaFree opioid anesthesia (FOA) has been used in many countries around the world, making use of multimodal analgesia therapy which includes hypnotics, N-methyl-D-aspartate (NMDA) antagonists, local anesthetics and anti-inflammatory agents and sympathetic block in surgery. This method was demonstrated to contribute to enhanced recovery after surgery (ERAS). The use of long-acting local anesthetics also enhances postoperative pain relief. As a result, the concept of balanced anesthesia now has a change in three basic components: hypnotics, muscle relaxants and sympathomimetic inhibitors | Procedure or surgery | Free-opioid anesthesia |
| opioid anesthesiaOpioids have been used as one of three basic components of balanced anesthesia, including anesthetic drugs, pain relievers, and neuromuscular blockade agents (opioid anesthesia). Opioids not only facilitate deep anesthesia but also create the most favorable conditions for surgeries. Fentanyl is a potent opioid used to control pain, reduce the dose of sympathomimetic inhibitors and maintain hemodynamic stability. However, several common side effects of fentanyl are well known: nausea and vomiting, constipation, urinary retention, headache, pruritus, rash, histamine release, biliary spasm and respiratory depression, the most severe adverse effect | Procedure or surgery | Opioid anesthesia |
Primary outcome
analgesic efficacy of free-opioid anesthesia
Time frame: before induction of anesthesia
intraoperative alteration of Surgical Pleth Index (SPI). The Surgical Pleth Index (SPI) is an objective tool that can reflect nociception-antinociception balance and guide the use of intraoperative analgesics. The values of the SPI range from 0 to 100. During general anaesthesia, maintaining a value between 20 and 50 is generally recommended. When the SPI value is greater than 50 and exceeds 3-5 min, it routinely indicates that the noxious stimulation is too strong and that additional analgesic drugs are needed.
analgesic efficacy of free-opioid anesthesia
Time frame: After intubation
intraoperative alteration of Surgical Pleth Index (SPI)
analgesic efficacy of free-opioid anesthesia
Time frame: After skin incision
intraoperative alteration of Surgical Pleth Index (SPI)
analgesic efficacy of free-opioid anesthesia
Time frame: when the restoration of eyelids reflex emerged
intraoperative alteration of Surgical Pleth Index (SPI)
analgesic efficacy of free-opioid anesthesia
Time frame: Intraoperatively (From the induction of anesthesia to the emergence)
The number of times of intraoperative analgesics adjustment
analgesic efficacy of free-opioid anesthesia
Time frame: postoperatively (upto 3 days after surgery)
the proportion of patients requiring postoperative pain rescue
39 secondary outcomes
Effects of free-opioid anesthesia on intraoperative mean arterial blood pressure
Time frame: T0 (right after entering the operating theatre)
Effects of free-opioid anesthesia on intraoperative mean arterial blood pressure
Time frame: T1 (before induction of anesthesia)
Effects of free-opioid anesthesia on intraoperative mean arterial blood pressure
Time frame: T2 (patients lost eyelid reflex and response to verbal command)
Effects of free-opioid anesthesia on intraoperative mean arterial blood pressure
Time frame: T3 (before intubation)
Effects of free-opioid anesthesia on intraoperative mean arterial blood pressure
Time frame: T4 (after intubation)
Effects of free-opioid anesthesia on intraoperative mean arterial blood pressure
Time frame: T5 (before skin incision)
Effects of free-opioid anesthesia on intraoperative mean arterial blood pressure
Time frame: T6 (after skin incision)
Effects of free-opioid anesthesia on intraoperative mean arterial blood pressure
Time frame: T7 (colon release)
Effects of free-opioid anesthesia on intraoperative mean arterial blood pressure
Time frame: T8 (dissection of colorectal mesentery)
Effects of free-opioid anesthesia on intraoperative mean arterial blood pressure
Time frame: T9 (colon resection)
Effects of free-opioid anesthesia on intraoperative mean arterial blood pressure
Time frame: T10 (restore gastrointestinal flow)
Effects of free-opioid anesthesia on intraoperative mean arterial blood pressure
Time frame: T11 (drainage placement)
Effects of free-opioid anesthesia on intraoperative mean arterial blood pressure
Time frame: T12 (before skin closure)
Effects of free-opioid anesthesia on intraoperative mean arterial blood pressure
Time frame: T13 (immediately after skin closure)
Effects of free-opioid anesthesia on intraoperative mean arterial blood pressure
Time frame: T14 (eyelids reflex restored and patients eyes could open on command)
Effects of free-opioid anesthesia on intraoperative mean arterial blood pressure
Time frame: T15 (before extubation)
Effects of free-opioid anesthesia on intraoperative mean arterial blood pressure
Time frame: T16 (15 minutes after extubation)
Effects of free-opioid anesthesia on intraoperative heart rate
Time frame: T0 (right after entering the operating theatre)
Effects of free-opioid anesthesia on intraoperative heart rate
Time frame: T1 (before induction of anesthesia)
Effects of free-opioid anesthesia on intraoperative heart rate
Time frame: T2 (patients lost eyelid reflex and response to verbal command)
Effects of free-opioid anesthesia on intraoperative heart rate
Time frame: T3 (before intubation)
Effects of free-opioid anesthesia on intraoperative heart rate
Time frame: T4 (after intubation)
Effects of free-opioid anesthesia on intraoperative heart rate
Time frame: T5 (before skin incision)
Effects of free-opioid anesthesia on intraoperative heart rate
Time frame: T6 (after skin incision)
Effects of free-opioid anesthesia on intraoperative heart rate
Time frame: T7 (colon release)
Effects of free-opioid anesthesia on intraoperative heart rate
Time frame: T8 (dissection of colorectal mesentery)
Effects of free-opioid anesthesia on intraoperative heart rate
Time frame: T9 (colon resection)
Effects of free-opioid anesthesia on intraoperative heart rate
Time frame: T10 (restore gastrointestinal flow)
Effects of free-opioid anesthesia on intraoperative heart rate
Time frame: T11 (drainage placement)
Effects of free-opioid anesthesia on intraoperative heart rate
Time frame: T12 (before skin closure)
Effects of free-opioid anesthesia on intraoperative heart rate
Time frame: T13 (immediately after skin closure)
Effects of free-opioid anesthesia on intraoperative heart rate
Time frame: T14 (eyelids reflex restored and patients eyes could open on command)
Effects of free-opioid anesthesia on intraoperative heart rate
Time frame: T15 (before extubation)
Effects of free-opioid anesthesia on intraoperative heart rate
Time frame: T16 (15 minutes after extubation)
changes in the concentration of IL (Interleukin)-6
Time frame: Before surgery
changes in the concentration of IL (Interleukin)-6
Time frame: 1 hour after surgery
changes in the concentration of IL-10
Time frame: Before surgery
changes in the concentration of IL-10
Time frame: 1 hour after surgery
Adverse effects of free-opioid anesthesia
Time frame: up to 3 days postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
- Results publication: PubMed 29207810Vaswani JP, Debata D, Vyas V, Pattil S. Comparative Study of the Effect of Dexmedetomidine Vs. Fentanyl on Haemodynamic Response in Patients Undergoing Elective Laparoscopic Surgery. J Clin Diagn Res. 2017 Sep;11(9):UC04-UC08. doi: 10.7860/JCDR/2017/27020.10578. Epub 2017 Sep 1.
- Results publication: PubMed 35945992Choi H, Song JY, Oh EJ, Chae MS, Yu S, Moon YE. The Effect of Opioid-Free Anesthesia on the Quality of Recovery After Gynecological Laparoscopy: A Prospective Randomized Controlled Trial. J Pain Res. 2022 Aug 3;15:2197-2209. doi: 10.2147/JPR.S373412. eCollection 2022.
- Results publication: PubMed 25925031Bakan M, Umutoglu T, Topuz U, Uysal H, Bayram M, Kadioglu H, Salihoglu Z. Opioid-free total intravenous anesthesia with propofol, dexmedetomidine and lidocaine infusions for laparoscopic cholecystectomy: a prospective, randomized, double-blinded study. Braz J Anesthesiol. 2015 May-Jun;65(3):191-9. doi: 10.1016/j.bjane.2014.05.001. Epub 2014 Jun 3.
- Results publication: PubMed 31198230Hakim KYK, Wahba WZB. Opioid-Free Total Intravenous Anesthesia Improves Postoperative Quality of Recovery after Ambulatory Gynecologic Laparoscopy. Anesth Essays Res. 2019 Apr-Jun;13(2):199-203. doi: 10.4103/aer.AER_74_19.
- Results publication: PubMed 30180150Chin KJ, Lewis S. Opioid-free Analgesia for Posterior Spinal Fusion Surgery Using Erector Spinae Plane (ESP) Blocks in a Multimodal Anesthetic Regimen. Spine (Phila Pa 1976). 2019 Mar 15;44(6):E379-E383. doi: 10.1097/BRS.0000000000002855.
- Individual participant dataSharing planned: Yes. The datasets used and/or analyzed during this study are available from the corresponding author on reasonable request. Researchers could contact the corresponding author via email to ask for IPD.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kien T Nguyen, Ph.D study director
Center of Emergency, Critical Care Medicine and Clinical Toxicology, Military Hospital 103, Vietnam
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Free-opioid anesthesia and opioid anesthesia in people with Colorectal Cancer, run by Vietnam Military Medical University at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
analgesic efficacy of free-opioid anesthesia (time frame: before induction of anesthesia). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06042816, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2023.