NCT07077031

Comparison of Two Magnesium Sulfate Protocols in Opioid-Free Anesthesia for Bariatric Surgery

Comparison of Postoperative Morphine Requirements Between Two Magnesium Sulfate Administration Protocols in Opioid-Free Anesthesia for Bariatric Surgery

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 110 (actual)
• Sponsor: Hospital HM Nou Delfos · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This retrospective observational study aims to compare postoperative morphine consumption in patients undergoing bariatric surgery with opioid-free anesthesia (OFA) using two different intravenous magnesium sulfate administration protocols: a single bolus versus a bolus followed by continuous infusion. Medical records of 110 patients operated between June 2022 and December 2023 at Hospital HM Nou Delfos were reviewed. All patients received standardized OFA, and only the magnesium protocol varied between the groups. The primary objective was to evaluate total morphine consumption during the first 48 hours postoperatively. Secondary outcomes included pain scores, antiemetic use, and adverse events. This study was approved by the hospital's Research Ethics Committee (Protocol V3\_12.05.2025).

Detailed description

This is a retrospective, single-center, observational study conducted at Hospital HM Nou Delfos (Barcelona, Spain), which compares the effect of two intravenous magnesium sulfate (MgSO₄) administration protocols on postoperative opioid requirements in patients undergoing bariatric surgery under opioid-free anesthesia (OFA). The two magnesium protocols evaluated were: Group A: MgSO₄ bolus 40 mg/kg administered before induction. Group B: MgSO₄ bolus 50 mg/kg before induction followed by continuous infusion of 15 mg/kg/h until the end of surgery. All patients underwent standardized OFA including propofol, lidocaine, ketamine and dexmedetomidine. No intraoperative opioids were administered. Multimodal postoperative analgesia was provided in all cases(dexamethasone, paracetamol, and dexketoprofen). A total of 110 patients were included in the analysis, as defined in the original approved protocol (55 per group). The primary outcome was cumulative morphine consumption in the first 48 hours postoperatively. Secondary outcomes included: Pain scores at rest and with movement at 2, 6, 12, 24, and 48 hours Use of rescue analgesics Incidence of postoperative nausea and vomiting (PONV) Adverse events potentially related to OFA (e.g., hypotension, bradycardia) Data were extracted from electronic health records and analyzed using descriptive and inferential statistical methods. This study aims to contribute real-world evidence on magnesium strategies in OFA and to support the development of safe, cost-effective analgesic protocols in bariatric patients.

Conditions

• Postoperative Pain
• Obesity
• Bariatric Surgery
• Opioid-free Anesthesia

Timeline

• Start date: 2022-06-01
• Primary completion: 2023-12-31
• Completion: 2024-01-31
• First posted: 2025-07-22
• Last updated: 2025-07-22

Locations

1 site across 1 country: Spain