Skip to content

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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07077031
Acronym
OFA-MG
Enrollment
110
Registered
2025-07-22
Start date
2022-06-01
Completion date
2024-01-31
Last updated
2025-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Magnesium Sulfate, Morphine Consumption, Opioid-Free Anesthesia, TIVA, Multimodal Analgesia

Brief 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.

Interventions

None listed

Sponsors

Hospital HM Nou Delfos
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

Age between 18 and 65 years Body mass index (BMI) ≥ 30 kg/m² ASA physical status II or III Underwent laparoscopic bariatric surgery (sleeve gastrectomy or Roux-en-Y gastric bypass) under opioid-free total intravenous anesthesia

Exclusion criteria

Pregnancy or breastfeeding Chronic opioid use before surgery Known allergy to magnesium sulfate or any drug used in the anesthetic protocol Severe renal or hepatic insufficiency Untreated coagulopathy Active substance abuse Uncontrolled psychiatric disorders Intraoperative complications requiring deviation from the protocol Postoperative morphine consumption exceeding institutional standards

Design outcomes

Primary

MeasureTime frameDescription
Total postoperative morphine consumption (mg) within 48 hours after surgery0-48 hours after surgeryTotal amount of morphine administered within 48 hours after surgery, measured in milligrams, as recorded in the post-anesthesia care unit and hospital stay.

Secondary

MeasureTime frameDescription
Pain intensity using Visual Analog Scale (VAS)1, 2, 4, 24, and 48 hours postoperativelyPain intensity assessed using a 10-point Visual Analog Scale (VAS), where 0 represents no pain and 10 represents the worst imaginable pain.
Incidence of adverse eventsUp to 48 hours after surgeryNumber of patients experiencing side effects such as nausea, vomiting, pruritus, hypotension, bradycardia, ileus, or urinary retention.
Sleep quality reported by the patientWithin 24 hours after surgeryPatient-reported quality of sleep using a numeric scale from 1 (very poor) to 5 (very good).
Patient satisfaction with anesthesiaWithin 24 hours after surgerySatisfaction assessed using a standardized like scale questionnaire (1 = very dissatisfied, 5 = very satisfied).
Length of hospital stayUp to 5 days after surgeryTotal number of days from surgery to discharge, extracted from medical records.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026