OFA vs OBA in Bariatric Surgery

Completed

• Conditions: Obesity; Postoperative Pain; Bariatric Surgery; Opioid-free Anesthesia

• Registration Number: NCT07075302
• Lead Sponsor: Hospital HM Nou Delfos

Brief Summary

This study compares two different anesthesia techniques in patients with obesity undergoing bariatric surgery: one that includes opioids (OBA), and one that avoids them completely (OFA). The main goal is to determine whether avoiding opioids during surgery leads to lower postoperative morphine requirements and fewer side effects. Researchers reviewed medical records of 70 patients who had bariatric surgery between June 2022 and December 2023 at a hospital in Spain. The study evaluates pain levels, sedation, complications, and total morphine use in the first 48 hours after surgery.

Detailed Description

This is a single-center, retrospective, observational cohort study conducted at Hospital HM Nou Delfos (Barcelona, Spain). The aim is to compare postoperative opioid requirements and outcomes in patients with morbid obesity undergoing laparoscopic bariatric surgery, according to the intraoperative anesthesia technique used.

Two anesthetic strategies were evaluated:

Opioid-Free Anesthesia (OFA): Total intravenous anesthesia (TIVA) without opioids, using agents such as propofol, ketamine, dexmedetomidine, lidocaine and magnesium.

Opioid-Based Anesthesia (OBA): TIVA including opioids, following institutional standards.

Medical records of 70 patients (35 in each group) who underwent surgery between June 2022 and December 2023 were analyzed. Key data extracted included demographics, surgical duration, anesthetic drugs used, intraoperative complications, pain scores (VAS at 1, 2, 4, 24, and 48 hours), sedation levels (RAMSAY scale), adverse effects (e.g., nausea, vomiting, ileus, hypotension), and morphine consumption.

The primary outcome is total morphine use within the first 48 hours postoperatively. Secondary outcomes include pain scores, adverse events, time to awakening, and hospital length of stay. Statistical analysis was performed using descriptive and inferential methods, including regression models adjusted for age, sex, BMI, and comorbidities.

This study provides real-world evidence on the clinical impact of opioid-free anesthesia in bariatric patients, aiming to improve perioperative safety and enhance postoperative recovery.

Study Timeline

• Study Start: 2022-06-01
• Primary Completion: 2023-12-31
• Study Completion: 2024-01-31
• Status Verified: 2025-07
• Study First Submitted: 2025-07-11
• Study First Submitted QC: 2025-07-11
• Last Update Submitted: 2025-07-11
• Study First Posted: 2025-07-20
• Last Update Posted: 2025-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Total postoperative morphine consumption (mg)	From 0 to 48 hours after surgery	Cumulative amount of morphine (in milligrams) administered within the first 48 hours after surgery, as recorded in the post-anesthesia care unit and inpatient medical records.

Secondary Outcome Measures

Name	Time	Method
Sedation level (RAMSAY scale)	From 0 to 48 hours after surgery	Sedation assessed using the Ramsay Sedation Scale, ranging from 1 (anxious/agitated) to 6 (no response to stimuli).
Pain intensity (VAS)	At 1, 2, 4, 24, and 48 hours postoperatively	Pain evaluated using the Visual Analog Scale (VAS) from 0 (no pain) to 10 (worst imaginable pain), both at rest and with movement.
Incidence of adverse events	Up to 48 hours after surgery	Number of patients experiencing side effects such as nausea, vomiting, pruritus, hypotension, bradycardia, ileus, or urinary retention.
Length of hospital stay	From surgery until discharge (up to 7 days)	Total duration of hospital stay in days, calculated from the day of surgery to discharge date.
Time to awakening	Intraoperative period until recovery (measured at end of surgery)	Time in minutes from the end of surgery until patient opens eyes or responds to verbal commands.

Trial Locations

Locations (1)

Hospital HM Nou Delfos; 🇪🇸 Barcelona, Spain