Analgesics, OpioidNCT05004519
Benefits of Opioid Free Anesthesia on Morphine Consumption in Gastric Bypass
A study testing Dexmedetomidine Injection [Precedex] and Remifentanil in people with Analgesics, Opioid, run by matthieu clanet at 1 site in Belgium.
Trial summary
Opioid free anesthesia is a recent anesthesia technique with the aim to avoid peroperative use of morphinics to allow a diminution of secondary morphinics effects in the postoperative period. There is no robust data on the real benefits of such procedures. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Analgesics, Opioid
- What is being tested?
- Dexmedetomidine Injection [Precedex] and Remifentanil
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 183 participants
- Where
- 1 siteBelgium
- Study dates
- 5 Oct 2021to 15 Oct 2022
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of anesthesia score (ASA) 2-3
- Scheduled for a laparoscopic gastric bypass surgery
Who cannot join
- Patient refusal
- Medical diseases: Cardiac arrhythmia like atrioventricular block 2nd or 3rd degree, pacemaker, arterial hypotension, severe bradycardia, cerebrovascular pathology, renal and/or hepatic insufficiency
- Previous bariatric surgery
- Allergy to any medication used during the surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of an Opioid Free Anesthesia Protocol Compared to Multimodal Anesthesia on Postoperative Morphine Consumption in an Enhanced Recovery After Gastric Bypass Surgery Protocol: a Prospective, Double Blind Study
Opioid free anesthesia is a recent anesthesia technique with the aim to avoid peroperative use of morphinics to allow a diminution of secondary morphinics effects in the postoperative period.
There is no robust data on the real benefits of such procedures. Obese patients are particular at risk of secondary effects of opioids. The aim of our study is to compare opioid free anesthesia to multimodal anesthesia on postoperative morphine consumption after a laparoscopic gastric bypass.
Read the detailed description
The aim of the study is to study the impact of an opioid free anesthesia protocol on the postoperative morphine consumption in laparoscopic gastric bypass compared to a multimodal anesthesia protocol.
183 morbidly obese patients (Body mass index >40Kg/m2 or >35kg/m2 AND/OR diabete mellitus AND/OR sleep apnea syndrome AND/OR arterial hypertension.
A randomization will allocate two groups of 100 patients in:
- Group 1: Multimodal anesthesia without opioids
- Group 2: Multimodal anesthesia with opioid The patient, the anesthesist and the data evaluator will be all blinded about the allocation of the patient.
- Conditions
- Analgesics, Opioid
- Being tested
- Dexmedetomidine Injection [Precedex], Remifentanil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexmedetomidine Injection [Precedex]Drug
dexmedetomidine or remifentanil during laparoscopic gastric bypass
RemifentanilDrug
dexmedetomidine or remifentanil during laparoscopic gastric bypass
| Study group | Role | What they receive |
|---|---|---|
| Opioid free anesthesia | Experimental | Dexmedetomidine 0,5 microgrammes/kg of ideal body weight (IBW) + magnesium 40 mg/kg of total body weight (TBW) in 10 minutes
* Dexmedetomidine 0,4- 0,8 microgrammes/kg of IBW/h;Lidocaine 2% 49ml+ Ketamine 50mg: 1ml/10kg of IBW/ hour;Ketamine 25 mg;lidocaïne 1,5 mg/kg IBW;Propofol 2mg/kgTBW;Rocuronium 1,2 mg/kg IBW;Cefazoline 2g if >120 kg, 3g if >120Kg;Paracetamol 15 mg/ KgTBW;Diclofenac 75 mg;Dexamethasone 10 mg;Ondansetron 4 mg;Sevorane;dexmedetomidine: 0,4-0,8 microgramme/kg/h;Rocuronium 0,1 mg/kg of IBW if posttetanic count>1/10;Atropine 0,5 mg if heart rate < 40/min;Ephedrine 5mg in Arterial mean pressure < 20% of basal value;Nicardipine 0,5 mg if Arterial mean pressure > 20% of basal value Emergence
* Stop dexmedetomidine;Stop sevorane;1 ml of NaCL 0,9%;Suggamadex 4 mg/ kg of IBW+ 4mg/kg of 40% ABW Post-anesthesia:Lidocaïne 2% 49ml + Ketamine 50 mg: 0,5 ml/ 10 kg IBW;Paracetamol 1g/6h;Diclofenac 75mg/12h;Morphine patient controlled analgesia: 1 mg/5 min, maximum 20mg/ 4 hours Receives: Drug: Dexmedetomidine Injection [Precedex] |
| Multimodal anesthesia | Experimental | magnesium 40 mg/kg of total body weight (TBW) in 10 minutes
* Remifentanil 0,2-0,4 microgrammes/kg/min of ideal body weight; Saline 0,9%: Infusion at 1ml/10kg of ideal body weight/ hour;Ketamine 25 mg;lidocaïne 1,5 mg/kg IBW;Propofol 2mg/kgTBW;Rocuronium 1,2 mg/kg IBW;Cefazoline 2g if >120 kg, 3g if >120Kg;Paracetamol 15 mg/ Kg TBW;Diclofenac 75 mg;Dexamethasone 10 mg;Ondansetron 4 mg;Sevorane;remifentanil 0,2-0,4 microgrammes/kg/min;Rocuronium 0,1 mg/kg of IBW if posttetanic count>1/10;Atropine 0,5 mg if heart rate < 40/min;Ephedrine 5mg in Arterial mean pressure < 20% of basal value;Nicardipine 0,5 mg if Arterial mean pressure > 20% of basal value Emergence
* Stop remifentanil;Stop sevorane;1 ml of morphine 10mg/ml;Suggamadex 4 mg/ kg of IBW+ 4mg/kg of 40% ABW Post-anesthesia:Salne 50ml: 0,5 ml/ 10 kg IBW;Paracetamol 1g/6h;Diclofenac 75mg/12h;Morphine patient controlled analgesia: 1 mg/5 min, maximum 20mg/ 4 hours Receives: Drug: Remifentanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Morphine consumption
total morphine consumption from the PACU arrival to the 24 h post-surgery
Measured: 24 hours after surgery
Secondary outcomes (8)
Visual analog scale
Measured: Post Anesthesia Care Unit admission (Hour 0), Hour +4, Hour +24
Morphine consumption
Measured: Post Anesthesia Care Unit admission (Hour 0), Hour +4
Quality of Recovery 40 score
Recovery scale: From 40 (worst recovery) to 200 (Best Recovery)
Measured: operative Day -1, Operative day +1, operative day +30
Hypoxemia
SpO2 < 90% on 2 liters of nasal Oxygen
Measured: up to patient discharge
Postoperative Nausea and vomiting
Measured: Post Anesthesia Care Unit admission (Hour 0), Hour +4, Hour +24
Need of Antiemetics
Measured: Up to patient discharge
Bradycardia and use of atropine
Measured: Up to patient discharge
Readmissions rate
Admission of the patient in hospital during the first 30 postoperative days
Measured: Up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2021
- Study start5 Oct 2021
- Primary completion15 Sep 2022
- Study completion15 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Analgesics, OpioidStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 183 participants (actual)
Sponsor and investigators
- Lead sponsor
- matthieu clanet
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, matthieu clanet, Chirec
- Investigators
- matthieu Clanet, Principal investigator, Chirec
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05004519
- Sponsor's protocol ID
- P2021/378
- Status last verified
- Nov 2023
- First submitted
- 3 Aug 2021
- Last updated
- 30 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Study protocol, informed consent form
Publications
Clanet M, Touihri K, El Haddad C, Goldsztejn N, Himpens J, Fils JF, Gricourt Y, Van der Linden P, Coeckelenbergh S, Joosten A, Dandrifosse AC. Effect of opioid-free versus opioid-based strategies during multimodal anaesthesia on postoperative morphine consumption after bariatric surgery: a randomised double-blind clinical trial. BJA Open. 2024 Feb 23;9:100263. doi: 10.1016/j.bjao.2024.100263. eCollection 2024 Mar.
PubMed 38435809
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of an Opioid Free Anesthesia Protocol Compared to Multimodal Anesthesia on Postoperative Morphine Consumption in an Enhanced Recovery After Gastric Bypass Surgery Protocol: a Prospective, Double Blind Study
- ClinicalTrials.gov ID
- NCT05004519
- Acronym / sponsor ID
- P2021/378
- Conditions
- Analgesics, Opioid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 183 participants (actual)
- Lead sponsor
- matthieu clanetUniversity, hospital or other
- Study start
- 5 Oct 2021 (actual)
- Primary completion
- 15 Sep 2022 (actual)
- Study completion
- 15 Oct 2022 (actual)
- First posted
- 13 Aug 2021 (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 a recent anesthesia technique with the aim to avoid peroperative use of morphinics to allow a diminution of secondary morphinics effects in the postoperative period.
There is no robust data on the real benefits of such procedures. Obese patients are particular at risk of secondary effects of opioids. The aim of our study is to compare opioid free anesthesia to multimodal anesthesia on postoperative morphine consumption after a laparoscopic gastric bypass.
Detailed description
The aim of the study is to study the impact of an opioid free anesthesia protocol on the postoperative morphine consumption in laparoscopic gastric bypass compared to a multimodal anesthesia protocol.
183 morbidly obese patients (Body mass index >40Kg/m2 or >35kg/m2 AND/OR diabete mellitus AND/OR sleep apnea syndrome AND/OR arterial hypertension.
A randomization will allocate two groups of 100 patients in:
- Group 1: Multimodal anesthesia without opioids
- Group 2: Multimodal anesthesia with opioid The patient, the anesthesist and the data evaluator will be all blinded about the allocation of the patient.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Opioid free anesthesia | Experimental | Drug: Dexmedetomidine Injection [Precedex]Dexmedetomidine 0,5 microgrammes/kg of ideal body weight (IBW) + magnesium 40 mg/kg of total body weight (TBW) in 10 minutes * Dexmedetomidine 0,4- 0,8 microgrammes/kg of IBW/h;Lidocaine 2% 49ml+ Ketamine 50mg: 1ml/10kg of IBW/ hour;Ketamine 25 mg;lidocaïne 1,5 mg/kg IBW;Propofol 2mg/kgTBW;Rocuronium 1,2 mg/kg IBW;Cefazoline 2g if >120 kg, 3g if >120Kg;Paracetamol 15 mg/ KgTBW;Diclofenac 75 mg;Dexamethasone 10 mg;Ondansetron 4 mg;Sevorane;dexmedetomidine: 0,4-0,8 microgramme/kg/h;Rocuronium 0,1 mg/kg of IBW if posttetanic count>1/10;Atropine 0,5 mg if heart rate < 40/min;Ephedrine 5mg in Arterial mean pressure < 20% of basal value;Nicardipine 0,5 mg if Arterial mean pressure > 20% of basal value Emergence * Stop dexmedetomidine;Stop sevorane;1 ml of NaCL 0,9%;Suggamadex 4 mg/ kg of IBW+ 4mg/kg of 40% ABW Post-anesthesia:Lidocaïne 2% 49ml + Ketamine 50 mg: 0,5 ml/ 10 kg IBW;Paracetamol 1g/6h;Diclofenac 75mg/12h;Morphine patient controlled analgesia: 1 mg/5 min, maximum 20mg/ 4 hours |
| Multimodal anesthesia | Experimental | Drug: Remifentanilmagnesium 40 mg/kg of total body weight (TBW) in 10 minutes * Remifentanil 0,2-0,4 microgrammes/kg/min of ideal body weight; Saline 0,9%: Infusion at 1ml/10kg of ideal body weight/ hour;Ketamine 25 mg;lidocaïne 1,5 mg/kg IBW;Propofol 2mg/kgTBW;Rocuronium 1,2 mg/kg IBW;Cefazoline 2g if >120 kg, 3g if >120Kg;Paracetamol 15 mg/ Kg TBW;Diclofenac 75 mg;Dexamethasone 10 mg;Ondansetron 4 mg;Sevorane;remifentanil 0,2-0,4 microgrammes/kg/min;Rocuronium 0,1 mg/kg of IBW if posttetanic count>1/10;Atropine 0,5 mg if heart rate < 40/min;Ephedrine 5mg in Arterial mean pressure < 20% of basal value;Nicardipine 0,5 mg if Arterial mean pressure > 20% of basal value Emergence * Stop remifentanil;Stop sevorane;1 ml of morphine 10mg/ml;Suggamadex 4 mg/ kg of IBW+ 4mg/kg of 40% ABW Post-anesthesia:Salne 50ml: 0,5 ml/ 10 kg IBW;Paracetamol 1g/6h;Diclofenac 75mg/12h;Morphine patient controlled analgesia: 1 mg/5 min, maximum 20mg/ 4 hours |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- American Society of anesthesia score (ASA) 2-3
- Scheduled for a laparoscopic gastric bypass surgery
Key exclusion criteria (4 listed)
- Patient refusal
- Medical diseases: Cardiac arrhythmia like atrioventricular block 2nd or 3rd degree, pacemaker, arterial hypotension, severe bradycardia, cerebrovascular pathology, renal and/or hepatic insufficiency
- Previous bariatric surgery
- Allergy to any medication used during the surgery
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 Injection [Precedex]dexmedetomidine or remifentanil during laparoscopic gastric bypass | Drug | Opioid free anesthesia |
| Remifentanildexmedetomidine or remifentanil during laparoscopic gastric bypass | Drug | Multimodal anesthesia |
Primary outcome
Total Morphine consumption
Time frame: 24 hours after surgery
total morphine consumption from the PACU arrival to the 24 h post-surgery
8 secondary outcomes
Visual analog scale
Time frame: Post Anesthesia Care Unit admission (Hour 0), Hour +4, Hour +24
Morphine consumption
Time frame: Post Anesthesia Care Unit admission (Hour 0), Hour +4
Quality of Recovery 40 score
Time frame: operative Day -1, Operative day +1, operative day +30
Hypoxemia
Time frame: up to patient discharge
Postoperative Nausea and vomiting
Time frame: Post Anesthesia Care Unit admission (Hour 0), Hour +4, Hour +24
Need of Antiemetics
Time frame: Up to patient discharge
Bradycardia and use of atropine
Time frame: Up to patient discharge
Readmissions rate
Time frame: Up to 30 days
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 30 Nov 2023.
- Derived from this study: PubMed 38435809Clanet M, Touihri K, El Haddad C, Goldsztejn N, Himpens J, Fils JF, Gricourt Y, Van der Linden P, Coeckelenbergh S, Joosten A, Dandrifosse AC. Effect of opioid-free versus opioid-based strategies during multimodal anaesthesia on postoperative morphine consumption after bariatric surgery: a randomised double-blind clinical trial. BJA Open. 2024 Feb 23;9:100263. doi: 10.1016/j.bjao.2024.100263. eCollection 2024 Mar.
- Individual participant dataSharing planned: No. Study protocol, informed consent form
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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.
matthieu Clanet principal investigator
Chirec
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 Injection [Precedex] and Remifentanil in people with Analgesics, Opioid, run by matthieu clanet at 1 site in Belgium.
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 4 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 30 Nov 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 Belgium. 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?
Total Morphine consumption (time frame: 24 hours after surgery). 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 NCT05004519, which also lists 1 linked publication.
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 30 Nov 2023.