ObesityPhase 4NCT04260659
Opioid Free vs Opioid Based Anesthesia for Laparoscopic Sleeve Gastrectomy
A Phase 4 study testing Dexmedetomidine Hydrochloride [Dexdor], Remifentanil [Ultiva] and Ketamine [Ketalar] in people with Obesity and Postoperative Pain, run by Medical University of Warsaw at 1 site in Poland.
Trial summary
Opioid free anesthesia is an anesthetic technique, in which administration of multimodal analgesia and sympathicolytics provides hemodynamic stability without use of opioids. Such management may be beneficial to the obese patients undergoing laparoscopic sleeve gastrectomy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity, Postoperative Pain, Postoperative Nausea
- What is being tested?
- Dexmedetomidine Hydrochloride [Dexdor], Remifentanil [Ultiva] and Ketamine [Ketalar]
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 sitePoland
- Study dates
- 4 Feb 2020to 22 Feb 2023
- Phase
- Phase 4
- 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
- Sleeve gastrectomy in patients with BMI > 40 or >35 with comorbidities
- Written informed consent
Who cannot join
- Patient's refusal
- Known allergies to study medication
- Inability to comprehend or participate In pain scoring scale
- Inability to use intravenous patient controlled analgesia
- Changes of operation extent during procedure
- Revisional operations
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Opioid Free vs Opioid Based Anesthesia for Laparoscopic Sleeve Gastrectomy: Clinical, Randomised Study
Opioid free anesthesia is an anesthetic technique, in which administration of multimodal analgesia and sympathicolytics provides hemodynamic stability without use of opioids. Such management may be beneficial to the obese patients undergoing laparoscopic sleeve gastrectomy. Our study aims to compare opioid free anesthesia in such patients with standard, short-acting opioid based.
Read the detailed description
The study has been approved by Bioethical Committee of Medical University of Warsaw. Informed written consent will be obtained from all patients. Sample size of 60 patients has been calculated based on the Altman normogram to obtain 30% reduction of postoperative opioid consumption with significance and power of 90%.
Consenting patients scheduled for laparoscopic sleeve gastrectomy will be randomly assigned to the computer generated list to receive opioid free or standard opioid based anesthesia.
Opioid free protocol includes administration of dexmedetomidine, lidocaine, ketamine, magnesium sulphate whereas standard group will receive remifentanil TCI Minto Model.
After the end of operation all of the patient will receive oxycodone and additional doses via PCA system for postoperative analgesia.
- Being tested
- Dexmedetomidine Hydrochloride [Dexdor], Remifentanil [Ultiva], Ketamine [Ketalar], Lidocaine [Xylocaine 2%], Magnesium Sulphate [Inj. Magnesii Sulfurici Polpharma]
- Keywords
- Opioid free anesthesia, Laparoscopic sleeve gastrectomy
- Medical subject headings
- Obesity, Pain, Postoperative, Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexmedetomidine Hydrochloride [Dexdor]Drug
Initial dosis of dexmedetomidine 1 mcg/kg IBW iv will be administered within 10 minutes before general anesthesia induction. Following intubation infusion of 1 mcg/kg IBW / h will be initiated and continued until the end of operation.
Remifentanil [Ultiva]Drug
Remifentanil TCI Minto Model will be used during induction in dosis 6 ng/ml and intraoperatively appropriately to maintain hemodynamical stability.
Ketamine [Ketalar]Drug
Ketamine 0,5mg/kg IBW iv will be administered during induction of general anesthesia.
Lidocaine [Xylocaine 2%]Drug
Initial dosis of lidocaine 1,5 mg/kg IBW iv will be administered within 10 minutes before general anesthesia induction. Following intubation infusion of 3 mg/kg IBW / h will be initiated and continued until the end of operation.
Magnesium Sulphate [Inj. Magnesii Sulfurici Polpharma]Drug
Magnesium Sulphate will be administered in dosis 50 mg/kg IBW iv intraoperatively.
Fentanyl [Fentanyl WZF]Drug
Rescue dosis of 100 mcg iv will be administered if hypertension > 140/90 mmHg or tachycardia > 120min occurs. If necessary rescue dosis may be repeated.
| Study group | Role | What they receive |
|---|---|---|
| Opioid liberal group | Active comparator | Not described Receives: Drug: Remifentanil [Ultiva] |
| Opioid free group | Experimental | Not described Receives: Drug: Dexmedetomidine Hydrochloride [Dexdor]; Drug: Ketamine [Ketalar]; Drug: Lidocaine [Xylocaine 2%]; Drug: Magnesium Sulphate [Inj. Magnesii Sulfurici Polpharma]; Drug: Fentanyl [Fentanyl WZF] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total postoperative oxycodone consumption
PCA (Patient's controlled analgesia) iv pump, oxycodone will be administered on patient's demand by 2mg boli, with lock out time 10 minutes
Measured: Day "0"
Postoperative pain score in NRS scale
NRS range from 0 for no pain to 10 for worst pain imaginable
Measured: Day "0", assessed 1 hour after operation
Postoperative pain score in NRS scale
NRS range from 0 for no pain to 10 for worst pain imaginable
Measured: Day "0", assessed 6 hours after operation
Postoperative pain score in NRS scale
NRS range from 0 for no pain to 10 for worst pain imaginable
Measured: Day "0", assessed 12 hours after operation
Postoperative pain score in NRS scale
NRS range from 0 for no pain to 10 for worst pain imaginable
Measured: Day "1" assessed 24 hours after operation
Secondary outcomes (10)
Postoperative sedation score
1-6 Ramsay sedation score; 1 - agitated or restless 6 - unresponsive
Measured: Day "0", assessed 1,6,12 and 24 hours after operation
Postoperative nausea and vomiting
Simplified PONV impact scale 0-6 0 - no nausea nor vomiting 6 - >3 episodes of vomiting and nausea all of the time
Measured: Day "0", assessed 1,6,12 and 24 hours after operation
Rescue fentanyl administration dosis
In opioid free group, rescue fentanyl dosis will be administered if hypertension > 140/90 mmHg or tachycardia > 120/min occurs
Measured: intraoperative
Highest BP
Highest BP during operation
Measured: intraoperative
Lowest BP
Lowest BP during operation
Measured: intraoperative
Highest HR
Highest HR during operation
Measured: intraoperative
Lowest HR
Lowest HR during operation
Measured: intraoperative
Total ephedrine dosis
Ephedrine is a vasopressor used in case of hypotension to maintain mean arterial pressure > 65 mmHg or to increase blood pressure to check surgical hemostasis
Measured: intraoperative
Postoperative desaturation
SpO2 < 94%
Measured: Day "0", assessed 1,6,12 and 24 hours after operation
Patient's comfort assessed in QoR-40 formulary
QoR-40 scale is used to measure the quality of recovery after surgery and anesthesia, it is a 40 item questionnaire that provides a score across five dimensions: patient support, comfort, emotions, physical independence, and pain. Formulary will assess first 24 hours following the operation and will be filled by the patient 7 days after operation
Measured: 7 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2020
- Study start4 Feb 2020
- Primary completion6 Oct 2022
- Study completion22 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Medical University of WarsawThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Piotr Mieszczański, MD, Principal investigator, Medical University of Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04260659
- Sponsor's protocol ID
- OFA LSG
- Status last verified
- Mar 2023
- First submitted
- 29 Jan 2020
- Last updated
- 8 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Opioid Free vs Opioid Based Anesthesia for Laparoscopic Sleeve Gastrectomy: Clinical, Randomised Study
- ClinicalTrials.gov ID
- NCT04260659
- Acronym / sponsor ID
- OFA LSG
- Keywords
- Opioid free anesthesia, Laparoscopic sleeve gastrectomy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Study start
- 4 Feb 2020 (actual)
- Primary completion
- 6 Oct 2022 (actual)
- Study completion
- 22 Feb 2023 (actual)
- First posted
- 7 Feb 2020 (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.
Opioid free anesthesia is an anesthetic technique, in which administration of multimodal analgesia and sympathicolytics provides hemodynamic stability without use of opioids. Such management may be beneficial to the obese patients undergoing laparoscopic sleeve gastrectomy. Our study aims to compare opioid free anesthesia in such patients with standard, short-acting opioid based.
Detailed description
The study has been approved by Bioethical Committee of Medical University of Warsaw. Informed written consent will be obtained from all patients. Sample size of 60 patients has been calculated based on the Altman normogram to obtain 30% reduction of postoperative opioid consumption with significance and power of 90%.
Consenting patients scheduled for laparoscopic sleeve gastrectomy will be randomly assigned to the computer generated list to receive opioid free or standard opioid based anesthesia.
Opioid free protocol includes administration of dexmedetomidine, lidocaine, ketamine, magnesium sulphate whereas standard group will receive remifentanil TCI Minto Model.
After the end of operation all of the patient will receive oxycodone and additional doses via PCA system for postoperative analgesia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Opioid liberal group | Active comparator | Drug: Remifentanil [Ultiva] |
| Opioid free group | Experimental | Drug: Dexmedetomidine Hydrochloride [Dexdor], Drug: Ketamine [Ketalar], Drug: Lidocaine [Xylocaine 2%], Drug: Magnesium Sulphate [Inj. Magnesii Sulfurici Polpharma], Drug: Fentanyl [Fentanyl WZF] |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Sleeve gastrectomy in patients with BMI > 40 or >35 with comorbidities
- Written informed consent
Key exclusion criteria (6 listed)
- Patient's refusal
- Known allergies to study medication
- Inability to comprehend or participate In pain scoring scale
- Inability to use intravenous patient controlled analgesia
- Changes of operation extent during procedure
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 Hydrochloride [Dexdor]Initial dosis of dexmedetomidine 1 mcg/kg IBW iv will be administered within 10 minutes before general anesthesia induction. Following intubation infusion of 1 mcg/kg IBW / h will be initiated and continued until the end of operation. | Drug | Opioid free group |
| Remifentanil [Ultiva]Remifentanil TCI Minto Model will be used during induction in dosis 6 ng/ml and intraoperatively appropriately to maintain hemodynamical stability. | Drug | Opioid liberal group |
| Ketamine [Ketalar]Ketamine 0,5mg/kg IBW iv will be administered during induction of general anesthesia. | Drug | Opioid free group |
| Lidocaine [Xylocaine 2%]Initial dosis of lidocaine 1,5 mg/kg IBW iv will be administered within 10 minutes before general anesthesia induction. Following intubation infusion of 3 mg/kg IBW / h will be initiated and continued until the end of operation. | Drug | Opioid free group |
| Magnesium Sulphate [Inj. Magnesii Sulfurici Polpharma]Magnesium Sulphate will be administered in dosis 50 mg/kg IBW iv intraoperatively. | Drug | Opioid free group |
| Fentanyl [Fentanyl WZF]Rescue dosis of 100 mcg iv will be administered if hypertension > 140/90 mmHg or tachycardia > 120min occurs. If necessary rescue dosis may be repeated. | Drug | Opioid free group |
Primary outcome
Total postoperative oxycodone consumption
Time frame: Day "0"
PCA (Patient's controlled analgesia) iv pump, oxycodone will be administered on patient's demand by 2mg boli, with lock out time 10 minutes
Postoperative pain score in NRS scale
Time frame: Day "0", assessed 1 hour after operation
NRS range from 0 for no pain to 10 for worst pain imaginable
Postoperative pain score in NRS scale
Time frame: Day "0", assessed 6 hours after operation
NRS range from 0 for no pain to 10 for worst pain imaginable
Postoperative pain score in NRS scale
Time frame: Day "0", assessed 12 hours after operation
NRS range from 0 for no pain to 10 for worst pain imaginable
Postoperative pain score in NRS scale
Time frame: Day "1" assessed 24 hours after operation
NRS range from 0 for no pain to 10 for worst pain imaginable
10 secondary outcomes
Postoperative sedation score
Time frame: Day "0", assessed 1,6,12 and 24 hours after operation
Postoperative nausea and vomiting
Time frame: Day "0", assessed 1,6,12 and 24 hours after operation
Rescue fentanyl administration dosis
Time frame: intraoperative
Highest BP
Time frame: intraoperative
Lowest BP
Time frame: intraoperative
Highest HR
Time frame: intraoperative
Lowest HR
Time frame: intraoperative
Total ephedrine dosis
Time frame: intraoperative
Postoperative desaturation
Time frame: Day "0", assessed 1,6,12 and 24 hours after operation
Patient's comfort assessed in QoR-40 formulary
Time frame: 7 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 8 Mar 2023.
- Individual participant dataSharing planned: Yes
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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.
Piotr Mieszczański, MD principal investigator
Medical University of Warsaw
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexmedetomidine Hydrochloride [Dexdor], Remifentanil [Ultiva] and Ketamine [Ketalar] in people with Obesity and Postoperative Pain, run by Medical University of Warsaw at 1 site in Poland.
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 2 inclusion and 6 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 8 Mar 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 Poland. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Total postoperative oxycodone consumption (time frame: Day "0"). The study lists 5 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 8 Mar 2023.