Comparing Opioid Free and Opioid Based Anaesthesia in Bariatric Surgery
Evaluation of the Stress Response in Bariatric Surgery With and Without the Use of Opioids
This study is testing whether using an opioid-free anesthesia approach during bariatric surgery helps manage pain better than traditional opioid-based anesthesia.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | G.Gennimatas General Hospital Academic / other |
| Locations | 1 site (Athens) |
| Trial ID | NCT05752799 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effects of Opioid Free Anaesthesia versus Opioid Based Anaesthesia in patients undergoing sleeve gastrectomy. Participants will be randomly assigned to one of two groups, with the Opioid Free group receiving a combination of magnesium sulfate, dexmedetomidine, and ketamine, while the Opioid Based group will receive fentanyl and remifentanil. The study will utilize the Nociceptive Level Index algorithm to monitor pain levels and adjust analgesia accordingly. Blood samples will also be collected to assess the stress response associated with each anaesthesia method.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with a confirmed diagnosis of morbid obesity who are scheduled for elective laparoscopic sleeve gastrectomy.
Not a fit: Patients with certain cardiovascular issues, obstructive sleep apnea, or a history of depression may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved pain management and reduced opioid use in bariatric surgery patients.
How similar studies have performed: Other studies have shown promising results with opioid-sparing techniques in surgical settings, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age \>18y and \<75y * morbid obesity confirmed diagnosis * American Society of Anesthesiologists (ASA) II-III * elective laparoscopic sleeve gastrectomy surgery * signed informed consent Exclusion Criteria: * bradycardia, bundle branch block, hypotension, postural hypotension * obstructive sleep apnoea * history of depression * chronic corticosteroid use or intraoperative administration of more than 8mg of prednisolone or equivalent * refusal to participate
Where this trial is running
Athens
- G.Gennimatas General Hospital — Athens, Greece (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.