Opioid Free AnesthesiaNCT05481970
Opioid Free Anesthesia in Obese Patients.
A study testing dexmedetomidine,ketamine,lidocaine,propofol and fentanyl,propofol in people with Opioid Free Anesthesia, run by Fayoum University Hospital at 1 site in Egypt.
Trial summary
Using opioids in the clinical practice of anesthesia was astonishing. They are good analgesics and used widely to modulate perioperative pain, but analgesia with these drugs can be associated with many side effects that may lead to prolongation of hospital stay and recovery period like respiratory depression… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Opioid Free Anesthesia
- What is being tested?
- dexmedetomidine,ketamine,lidocaine,propofol and fentanyl,propofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2022to 5 Nov 2023
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- American Society of Anesthesiologist (ASA) physical status Ⅱ , Ⅲ.
- body mass index (BMI) ≥30 kg/m2.
- Have upper limb surgeries (orthopedics, plastic,…) under general anesthesia.
Who cannot join
- Known allergy to the drugs will be used in the study.
- Pregnancy and lactation.
- Addiction or recent use of opioids'
- Patients will not be able deal with visual analog score(VAS).
- Hepatic, Renal and cardiac diseases in advanced stages.
- History of epilepsy or seizures.
- Patients with cerebrovascular disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Opioid Free Anesthesia for Upper Limb Surgery in Obese Patients.
Using opioids in the clinical practice of anesthesia was astonishing. They are good analgesics and used widely to modulate perioperative pain, but analgesia with these drugs can be associated with many side effects that may lead to prolongation of hospital stay and recovery period like respiratory depression, delirium, impaired gastrointestinal function, urine retention, post-operative nausea and vomiting (PONV), and addiction. The most significant opioid side effect is respiratory depression. This is especially important in patients suffering from obesity. Obese patients already have a restrictive lung disease leading to decrease in functional residual capacity and total lung compliance. Anesthetics and analgesics specially opioids make these respiratory problems become worse with increasing the incidence of hypoxia. These side effects can be avoided by using opioid free anesthesia (OFA) techniques.
Opioid free anesthesia recently become more applicable and popular in different centers, it provides pain control with marked reduction in opioid consumption. However, researches and studies still unable to explore definite explanations or techniques regarding it. The base of OFA is that not only one drug can replace opioids. It is a multimodal anesthesia. Multiple drugs are used to achieve it. They are hypnotics,N-methyl-D-aspartate (NMDA) antagonists (ketamine, magnesium sulfate), sodium channel blockers (local anesthetics), anti-inflammatory drugs (NSAID, dexamethasone), and alpha-2 agonists (dexmedetomidine, clonidine). Regional anesthesia and nerve blocks also have a role. In this study, using OFA the investigators are hoping to achieve a good quality of care to obese patients helping in fast track surgery with less complications and so shorter period of hospital stay
Read the detailed description
Patients will be randomly allocated (by closed envelope method) to two groups:
Group A (n=38) will have opioid free anesthesia (OFA) Group B (n=38) will have opioid based anesthesia (OPA) All patients will be subjected to a preoperative clinical examination and routine preoperative laboratory investigations. Patients also will be trained on how to deal with the VAS score before surgery. The visual analog scale (VAS) is a pain score using a 10-cm line with two ends "no pain" on the left end and the "worst pain" on the right end, used to track pain for a patient or to compare pain between patients.(9,10) In the operating room (OR), peripheral oxygen saturation (spo2), noninvasive blood pressure and electrocardiogram ( ECG) will be monitored and recorded as a baseline reading. A peripheral intravenous cannula will be inserted t hen patients in both groups will receive 1mg of midazolam prior induction of anesthesia. Preoxygenation 3-5 minutes before induction will be done. Group (A): Induction of general anesthesia will be done using lidocaine (1.5 mg/kg), propofol (2-3 mg/kg), and atracurium (0.5 mg/kg). Dexmedetomidine 0.5 µg/kg over 10 min, started 10 min before induction. Following tracheal intubation, dexmedetomidine infusion generally will be initiated at 0.6 μg/kg/h and titrated between 0.2 and 1.0 μg/kg/h according to the heart rate maintaining bispectral index (BIS) between 40-60, lidocaine (1.5 mg/kg/h). ketamine will be given as a bolus dose of 0.3 mg/kg after induction and prior to skin incision then 0.2 mg/kg/h as an infusion. Patients will receive dexamethasone (8 mg i.v.) after induction. In group (B) for induction of anesthesia, patients will receive propofol 2-3mg/kg, fentanyl 1-2mcg/kg and atracurium 0.5 mg/kg as a muscle relaxant to facilitate intubation. Fentanyl bolus doses of 0.5-1 mcg/kg will be given to keep BIS score 40-60 during surgery.
All Patients will be mechanically ventilated with 50% O2 and 50% air and the end-tidal carbon dioxide( CO2) will be maintained between 30 - 35 mmHg. Anesthesia will be maintained by isoflurane and atracurium 0.1-0.2 mg/kg every 20-30 minutes. Reversal of muscle relaxants will done by using intravenous neostigmine (0.05 mg/kg) and atropine (0.01 mg/kg) at the end of surgery and the patient will be extubated when the patient will be able to breath spontaneously with tidal volume ≥5ml/kg and spo2>92%. Paracetamol 1gm i.v. infusion and ketorolac 30 mg slow i.v injection will be used at the end of surgery and before emergence in both groups. At the recovery room, patients will assess their pain and rating it using VAS score, monitored for postoperative pain, the patients will leave the post anesthesia care unit (PACU) with Aldrete score more than 9. (11) Any patient with Vas score ≥4, will receive tramadol 1mg/kg i.v. with a maximum dose 600mg/day.
- Conditions
- Opioid Free Anesthesia
- Being tested
- dexmedetomidine,ketamine,lidocaine,propofol, fentanyl,propofol
- Keywords
- opioid free anesthesia, obese, dexmedetomidine, ketamine
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dexmedetomidine,ketamine,lidocaine,propofolDrug
Also called dexamethasone
Group (A): Induction of general anesthesia will be done using lidocaine (1.5 mg/kg), propofol (2-3 mg/kg), and atracurium (0.5 mg/kg). Dexmedetomidine 0.5 µg/kg over 10 min, started 10 min before induction. Following tracheal intubation, dexmedetomidine infusion generally will be initiated at 0.6 μg/kg/h and titrated between 0.2 and 1.0 μg/kg/h according to the heart rate maintaining bispectral index (BIS) between 40-60, lidocaine (1.5 mg/kg/h). ketamine will be given as a bolus dose of 0.3 mg/kg after induction and prior to skin incision then 0.2 mg/kg/h as an infusion. Patients will receive dexamethasone (8 mg i.v.) after induction.
fentanyl,propofolDrug
Also called fentanyl
In group (B) for induction of anesthesia, patients will receive propofol 2-3mg/kg, fentanyl 1-2mcg/kg and atracurium 0.5 mg/kg as a muscle relaxant to facilitate intubation. Fentanyl bolus doses of 0.5-1 mcg/kg will be given to keep BIS score 40-60 during surgery.
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine group | Active comparator | Group A , Induction of general anesthesia will be done using lidocaine (1.5 mg/kg), propofol (2-3 mg/kg), and atracurium (0.5 mg/kg). Dexmedetomidine 0.5 µg/kg over 10 min, started 10 min before induction. Following tracheal intubation, dexmedetomidine infusion generally will be initiated at 0.6 μg/kg/h and titrated between 0.2 and 1.0 μg/kg/h according to the heart rate maintaining bispectral index (BIS) between 40-60, lidocaine (1.5 mg/kg/h). ketamine will be given as a bolus dose of 0.3 mg/kg after induction and prior to skin incision then 0.2 mg/kg/h as an infusion. Patients will receive dexamethasone (8 mg i.v.) after induction. Receives: Drug: dexmedetomidine,ketamine,lidocaine,propofol |
| Opioid group | Placebo comparator | In group (B) (OBA) for induction of anesthesia, patients will receive propofol 2-3mg/kg, fentanyl 1-2mcg/kg and atracurium 0.5 mg/kg as a muscle relaxant to facilitate intubation. Fentanyl bolus doses of 0.5-1 mcg/kg will be given to keep BIS score 40-60 during surgery. Receives: Drug: fentanyl,propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Attacks of postoperative pain with vas score ≥4
The visual analog scale (VAS) is a pain score using a 10-cm line with two ends "no pain" on the left end and the "worst pain" on the right end, postoperative pain with vas score ≥4 will be monitored and recorded
Measured: 24 hours postoperative
rescue doses of tramadol
time of rescue doses of tramadol
Measured: 24 hours postoperative
how many rescue doses of tramadol
number of rescue doses of tramadol
Measured: 24 hours postoperative
Secondary outcomes (8)
Hypoxia
number of patients with hypoxia (an Spo2 level of less than 95%)
Measured: every 2hours for 24 hours.
Postoperative nausea and vomiting.
Postoperative nausea and vomiting( number of attacks)
Measured: 24 hours postoperative
Postoperative usage of antiemetics
number of patients who will need rescue dose of antiemetic medication.
Measured: 24 hours postoperative
Intraoperative bradycardia
number of patients who will develop intra-operative bradycardia HR≤50bpm,
Measured: intraoperative
Intraoperative hypotension
number of patients who will develop intra-operative hypotension mean arterial blood pressure ( mABP) ≤60 millimetre of mercury (mmHg)
Measured: intraoperative
Intraoperative hypertension
number of patients who will develop intra-operative hypertension mABP ≥90mmHg).
Measured: intraoperative
ICU admission.
number of participants who will need intensive care unit
Measured: 24 hours postoperative
extubation time
time when endotracheal tube removed from the patients
Measured: 60 minutes after cessation of anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2022
- Study start1 Sep 2022
- Primary completion14 Aug 2023
- Study completion5 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid Free AnesthesiaStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fayoum University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rana Ahmed Abdelghaffar, Fayoum University Hospital
- Investigators
- Rana A Abelghaffar, MD, Principal investigator, Faculty of medicine , Fayoum university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05481970
- Sponsor's protocol ID
- opioid free anesthesia
- Status last verified
- Jul 2022
- First submitted
- 20 Jul 2022
- Last updated
- 20 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Opioid Free Anesthesia for Upper Limb Surgery in Obese Patients.
- ClinicalTrials.gov ID
- NCT05481970
- Acronym / sponsor ID
- opioid free anesthesia
- Conditions
- Opioid Free Anesthesia
- Keywords
- opioid free anesthesia, obese, dexmedetomidine, ketamine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Fayoum University HospitalUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 14 Aug 2023 (actual)
- Study completion
- 5 Nov 2023 (actual)
- First posted
- 1 Aug 2022 (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.
Using opioids in the clinical practice of anesthesia was astonishing. They are good analgesics and used widely to modulate perioperative pain, but analgesia with these drugs can be associated with many side effects that may lead to prolongation of hospital stay and recovery period like respiratory depression, delirium, impaired gastrointestinal function, urine retention, post-operative nausea and vomiting (PONV), and addiction. The most significant opioid side effect is respiratory depression. This is especially important in patients suffering from obesity. Obese patients already have a restrictive lung disease leading to decrease in functional residual capacity and total lung compliance. Anesthetics and analgesics specially opioids make these respiratory problems become worse with increasing the incidence of hypoxia. These side effects can be avoided by using opioid free anesthesia (OFA) techniques.
Opioid free anesthesia recently become more applicable and popular in different centers, it provides pain control with marked reduction in opioid consumption. However, researches and studies still unable to explore definite explanations or techniques regarding it. The base of OFA is that not only one drug can replace opioids. It is a multimodal anesthesia. Multiple drugs are used to achieve it. They are hypnotics,N-methyl-D-aspartate (NMDA) antagonists (ketamine, magnesium sulfate), sodium channel blockers (local anesthetics), anti-inflammatory drugs (NSAID, dexamethasone), and alpha-2 agonists (dexmedetomidine, clonidine). Regional anesthesia and nerve blocks also have a role. In this study, using OFA the investigators are hoping to achieve a good quality of care to obese patients helping in fast track surgery with less complications and so shorter period of hospital stay
Detailed description
Patients will be randomly allocated (by closed envelope method) to two groups:
Group A (n=38) will have opioid free anesthesia (OFA) Group B (n=38) will have opioid based anesthesia (OPA) All patients will be subjected to a preoperative clinical examination and routine preoperative laboratory investigations. Patients also will be trained on how to deal with the VAS score before surgery. The visual analog scale (VAS) is a pain score using a 10-cm line with two ends "no pain" on the left end and the "worst pain" on the right end, used to track pain for a patient or to compare pain between patients.(9,10) In the operating room (OR), peripheral oxygen saturation (spo2), noninvasive blood pressure and electrocardiogram ( ECG) will be monitored and recorded as a baseline reading. A peripheral intravenous cannula will be inserted t hen patients in both groups will receive 1mg of midazolam prior induction of anesthesia. Preoxygenation 3-5 minutes before induction will be done. Group (A): Induction of general anesthesia will be done using lidocaine (1.5 mg/kg), propofol (2-3 mg/kg), and atracurium (0.5 mg/kg). Dexmedetomidine 0.5 µg/kg over 10 min, started 10 min before induction. Following tracheal intubation, dexmedetomidine infusion generally will be initiated at 0.6 μg/kg/h and titrated between 0.2 and 1.0 μg/kg/h according to the heart rate maintaining bispectral index (BIS) between 40-60, lidocaine (1.5 mg/kg/h). ketamine will be given as a bolus dose of 0.3 mg/kg after induction and prior to skin incision then 0.2 mg/kg/h as an infusion. Patients will receive dexamethasone (8 mg i.v.) after induction. In group (B) for induction of anesthesia, patients will receive propofol 2-3mg/kg, fentanyl 1-2mcg/kg and atracurium 0.5 mg/kg as a muscle relaxant to facilitate intubation. Fentanyl bolus doses of 0.5-1 mcg/kg will be given to keep BIS score 40-60 during surgery.
All Patients will be mechanically ventilated with 50% O2 and 50% air and the end-tidal carbon dioxide( CO2) will be maintained between 30 - 35 mmHg. Anesthesia will be maintained by isoflurane and atracurium 0.1-0.2 mg/kg every 20-30 minutes. Reversal of muscle relaxants will done by using intravenous neostigmine (0.05 mg/kg) and atropine (0.01 mg/kg) at the end of surgery and the patient will be extubated when the patient will be able to breath spontaneously with tidal volume ≥5ml/kg and spo2>92%. Paracetamol 1gm i.v. infusion and ketorolac 30 mg slow i.v injection will be used at the end of surgery and before emergence in both groups. At the recovery room, patients will assess their pain and rating it using VAS score, monitored for postoperative pain, the patients will leave the post anesthesia care unit (PACU) with Aldrete score more than 9. (11) Any patient with Vas score ≥4, will receive tramadol 1mg/kg i.v. with a maximum dose 600mg/day.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine group | Active comparator | Drug: dexmedetomidine,ketamine,lidocaine,propofolGroup A , Induction of general anesthesia will be done using lidocaine (1.5 mg/kg), propofol (2-3 mg/kg), and atracurium (0.5 mg/kg). Dexmedetomidine 0.5 µg/kg over 10 min, started 10 min before induction. Following tracheal intubation, dexmedetomidine infusion generally will be initiated at 0.6 μg/kg/h and titrated between 0.2 and 1.0 μg/kg/h according to the heart rate maintaining bispectral index (BIS) between 40-60, lidocaine (1.5 mg/kg/h). ketamine will be given as a bolus dose of 0.3 mg/kg after induction and prior to skin incision then 0.2 mg/kg/h as an infusion. Patients will receive dexamethasone (8 mg i.v.) after induction. |
| Opioid group | Placebo comparator | Drug: fentanyl,propofolIn group (B) (OBA) for induction of anesthesia, patients will receive propofol 2-3mg/kg, fentanyl 1-2mcg/kg and atracurium 0.5 mg/kg as a muscle relaxant to facilitate intubation. Fentanyl bolus doses of 0.5-1 mcg/kg will be given to keep BIS score 40-60 during surgery. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- American Society of Anesthesiologist (ASA) physical status Ⅱ , Ⅲ.
- body mass index (BMI) ≥30 kg/m2.
- Have upper limb surgeries (orthopedics, plastic,…) under general anesthesia.
Key exclusion criteria (7 listed)
- Known allergy to the drugs will be used in the study.
- Pregnancy and lactation.
- Addiction or recent use of opioids'
- Patients will not be able deal with visual analog score(VAS).
- Hepatic, Renal and cardiac diseases in advanced stages.
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 |
|---|---|---|
| dexmedetomidine,ketamine,lidocaine,propofolAlso: dexamethasoneGroup (A): Induction of general anesthesia will be done using lidocaine (1.5 mg/kg), propofol (2-3 mg/kg), and atracurium (0.5 mg/kg). Dexmedetomidine 0.5 µg/kg over 10 min, started 10 min before induction. Following tracheal intubation, dexmedetomidine infusion generally will be initiated at 0.6 μg/kg/h and titrated between 0.2 and 1.0 μg/kg/h according to the heart rate maintaining bispectral index (BIS) between 40-60, lidocaine (1.5 mg/kg/h). ketamine will be given as a bolus dose of 0.3 mg/kg after induction and prior to skin incision then 0.2 mg/kg/h as an infusion. Patients will receive dexamethasone (8 mg i.v.) after induction. | Drug | Dexmedetomidine group |
| fentanyl,propofolAlso: fentanylIn group (B) for induction of anesthesia, patients will receive propofol 2-3mg/kg, fentanyl 1-2mcg/kg and atracurium 0.5 mg/kg as a muscle relaxant to facilitate intubation. Fentanyl bolus doses of 0.5-1 mcg/kg will be given to keep BIS score 40-60 during surgery. | Drug | Opioid group |
Primary outcome
Attacks of postoperative pain with vas score ≥4
Time frame: 24 hours postoperative
The visual analog scale (VAS) is a pain score using a 10-cm line with two ends "no pain" on the left end and the "worst pain" on the right end, postoperative pain with vas score ≥4 will be monitored and recorded
rescue doses of tramadol
Time frame: 24 hours postoperative
time of rescue doses of tramadol
how many rescue doses of tramadol
Time frame: 24 hours postoperative
number of rescue doses of tramadol
8 secondary outcomes
Hypoxia
Time frame: every 2hours for 24 hours.
Postoperative nausea and vomiting.
Time frame: 24 hours postoperative
Postoperative usage of antiemetics
Time frame: 24 hours postoperative
Intraoperative bradycardia
Time frame: intraoperative
Intraoperative hypotension
Time frame: intraoperative
Intraoperative hypertension
Time frame: intraoperative
ICU admission.
Time frame: 24 hours postoperative
extubation time
Time frame: 60 minutes after cessation of anesthesia
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 20 Feb 2024.
- Individual participant dataSharing planned: No
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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.
Rana A Abelghaffar, MD principal investigator
Faculty of medicine , Fayoum university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dexmedetomidine,ketamine,lidocaine,propofol and fentanyl,propofol in people with Opioid Free Anesthesia, run by Fayoum University Hospital at 1 site in Egypt.
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 3 inclusion and 7 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 20 Feb 2024. 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 Egypt. 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. Some participants in this study may receive a placebo. 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?
Attacks of postoperative pain with vas score ≥4 (time frame: 24 hours postoperative). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Feb 2024.