Opioid-Free vs Opioid-Based Anesthesia in Bariatric Surgery

Hospital dos Lusíadas

Status: Completed

Conditions: Postoperative Pain; Bariatric Surgery; Morbid Obesity; Opioid Free Anesthesia

Treatments: Drug: Opioid-Free Anesthesia (Dexmedetomidine-Ketamine-Lidocaine Protocol); Drug: Opioid-Based Anesthesia (Remifentanil-Based Protocol)

Study type: Interventional

Funder types: Other

Identifiers

NCT07337135

CESHLAM17072023

Details and patient eligibility

About

This prospective randomized controlled trial aims to compare the clinical effectiveness and safety of opioid-free anesthesia (OFA) versus traditional opioid-based anesthesia (OBA) in adult patients undergoing laparoscopic bariatric surgery. The study evaluates postoperative pain, need for rescue analgesia, incidence of postoperative nausea and vomiting (PONV), intraoperative nociception monitoring (NOL index), and patient satisfaction. A total of 60 patients were randomized into two parallel groups receiving either OFA or OBA according to standardized anesthetic protocols.

Full description

Bariatric surgery is the most effective treatment for severe and morbid obesity, but perioperative pain management and PONV remain significant challenges. Traditional opioid-based anesthesia is associated with adverse effects such as respiratory depression, postoperative hyperalgesia, ileus, and delayed recovery.

Opioid-free anesthesia is an emerging strategy based on the use of multimodal, non-opioid agents-including dexmedetomidine, lidocaine, and ketamine-aimed at providing adequate analgesia while reducing opioid-related complications.

This randomized controlled trial evaluates whether OFA improves postoperative pain control, reduces the requirement for rescue analgesia, and promotes better perioperative outcomes compared to OBA in laparoscopic bariatric surgery. Outcomes include NRS pain scores at multiple time points, NOL monitoring during surgery, PONV occurrence, and patient satisfaction at discharge.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥ 18 years;
• Body mass index (BMI ≥ 35 kg/m² with associated comorbidities) or BMI ≥ 40 kg/m²;
• Scheduled for elective laparoscopic bariatric surgery;
• Ability to provide informed consent.

Exclusion criteria

• Pregnancy;
• History of substance abuse;
• Severe psychiatric disease;
• Contraindications to any of the drugs used in either anesthetic protocol (dexmedetomidine, ketamine, lidocaine, remifentanil, etc.);
• Inability to comply with study procedures;
• Refusal or inability to provide informed consent.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Opioid-Based Anesthesia (OBA)

Active Comparator group

Description:

Standard opioid-based anesthesia using remifentanil infusion plus propofol induction, desflurane maintenance, and conventional multimodal analgesia, with opioids permitted for rescue.

Treatment:

Drug: Opioid-Based Anesthesia (Remifentanil-Based Protocol)

Opioid-Free Anesthesia (OFA)

Experimental group

Description:

Opioid-free anesthesia using dexmedetomidine, ketamine, and lidocaine infusion, combined with propofol induction, desflurane maintenance, and opioid-free multimodal analgesia, continued into early recovery.

Treatment:

Drug: Opioid-Free Anesthesia (Dexmedetomidine-Ketamine-Lidocaine Protocol)