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NCT Number: NCT07077031

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

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).

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Total postoperative morphine consumption (mg) within 48 hours after surgery

    Time frame: 0-48 hours after surgery

    Total amount of morphine administered within 48 hours after surgery, measured in milligrams, as recorded in the post-anesthesia care unit and hospital stay.

Secondary outcomes

  1. Pain intensity using Visual Analog Scale (VAS)

    Time frame: 1, 2, 4, 24, and 48 hours postoperatively

    Pain intensity assessed using a 10-point Visual Analog Scale (VAS), where 0 represents no pain and 10 represents the worst imaginable pain.

  2. Incidence of adverse events

    Time frame: Up to 48 hours after surgery

    Number of patients experiencing side effects such as nausea, vomiting, pruritus, hypotension, bradycardia, ileus, or urinary retention.

  3. Sleep quality reported by the patient

    Time frame: Within 24 hours after surgery

    Patient-reported quality of sleep using a numeric scale from 1 (very poor) to 5 (very good).

  4. Patient satisfaction with anesthesia

    Time frame: Within 24 hours after surgery

    Satisfaction assessed using a standardized like scale questionnaire (1 = very dissatisfied, 5 = very satisfied).

  5. Length of hospital stay

    Time frame: Up to 5 days after surgery

    Total number of days from surgery to discharge, extracted from medical records.

Sponsors and collaborators

Lead sponsor

Hospital HM Nou Delfos

Other

Registry information

Official study title

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

Acronym: OFA-MG

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Jul 22, 2025
Registry last updated
Jul 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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