Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05004519
Other study ID # P2021/378
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 5, 2021
Est. completion date October 15, 2022

Study information

Verified date November 2023
Source Chirec
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 183
Est. completion date October 15, 2022
Est. primary completion date September 15, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - American Society of anesthesia score (ASA) 2-3 - Scheduled for a laparoscopic gastric bypass surgery Exclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Dexmedetomidine Injection [Precedex]
dexmedetomidine or remifentanil during laparoscopic gastric bypass
Remifentanil
dexmedetomidine or remifentanil during laparoscopic gastric bypass

Locations

Country Name City State
Belgium CHIREC Delta Hospital Brussels

Sponsors (1)

Lead Sponsor Collaborator
matthieu clanet

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary Total Morphine consumption total morphine consumption from the PACU arrival to the 24 h post-surgery 24 hours after surgery
Secondary Visual analog scale Post Anesthesia Care Unit admission (Hour 0), Hour +4, Hour +24
Secondary Morphine consumption Post Anesthesia Care Unit admission (Hour 0), Hour +4
Secondary Quality of Recovery 40 score Recovery scale: From 40 (worst recovery) to 200 (Best Recovery) operative Day -1, Operative day +1, operative day +30
Secondary Hypoxemia SpO2 < 90% on 2 liters of nasal Oxygen up to patient discharge
Secondary Postoperative Nausea and vomiting Post Anesthesia Care Unit admission (Hour 0), Hour +4, Hour +24
Secondary Need of Antiemetics Up to patient discharge
Secondary Bradycardia and use of atropine Up to patient discharge
Secondary Readmissions rate Admission of the patient in hospital during the first 30 postoperative days Up to 30 days
See also
  Status Clinical Trial Phase
Completed NCT03380533 - Buprenorphine Transdermal Patches in Arthroscopic Rotator Cuff Repair Phase 2/Phase 3
Not yet recruiting NCT04836169 - Phase 1: Randomized Evaluation of a System to Deliver Mobile Cognitive Behavioral Therapy N/A
Completed NCT02987985 - Efficacy of Opioid-free Anesthesia in Reducing Postoperative Respiratory Depression in Children Undergoing Tonsillectomy Phase 3
Active, not recruiting NCT03366805 - A Patient Education Video Program for Post-Operative Recovery After Upper Extremity Surgery N/A
Recruiting NCT04144933 - Effect of Multimodal Opioid-free Anesthesia on Return of Bowel Function in Laparoscopic Colorectal Surgery Phase 3
Completed NCT04369950 - Post-cesarean Analgesia With Epidural Morphine Following Epidural 2-chloroprocaine Phase 4
Recruiting NCT05842928 - Patient-centred Deprescribing of Psychotropic, Sedative and Anticholinergic Medication in Elderly Patients With Polypharmacy N/A
Active, not recruiting NCT03485430 - Tapering From Long-term Opioid Therapy in Chronic Pain Population. Randomized Controlled Trial With 12 Months Follow up N/A
Completed NCT05099055 - Dexmedetomine as Adjuvant for Spinal Anesthesia in Elective Cesarian Sections : a Pilot Study Phase 3
Completed NCT03858621 - Comparison of Postoperative Nociception Between NOL-guided and Standard Intraoperative Analgesia Based on Fentanyl N/A
Recruiting NCT06390046 - Opioid-free Anesthesia, Optimization of Anesthesia After Bariatric Surgery N/A
Recruiting NCT06380244 - Opioid-free Anesthesia as an Alternative to General Anesthesia in Abdominal Surgery N/A
Completed NCT03991546 - Pain and Narcotic Usage After Orthopaedic Surgery N/A
Withdrawn NCT02985177 - A RCT of a Combination of Analgesics for Pain Management in Children With a Suspected Fracture Phase 4
Completed NCT05581901 - Perioperative Methadone in Hip Fracture Patients Phase 4
Withdrawn NCT04397458 - Rescue Quadratus Lumborum Blocks for Post-cesarean Pain Phase 4
Completed NCT03294109 - Evaluation of Abdominal Wall Block With Liposomal Bupivacaine for Post-Operative Analgesia in Donor Nephrectomy Phase 4
Completed NCT04204967 - Totally Transdermal Sedation in the Weaning From Remifentanil Infusion Phase 2
Completed NCT02665429 - A Quality Improvement Project to Investigate Individual Provider Variation in Opioid Prescribing From the Emergency Department N/A
Completed NCT04355468 - Opioid Free Anesthesia in Thoracic Surgery N/A