NCT05887258

Opioid-free Vs Traditional Balanced Anesthesia in Laparoscopic Colorectal Surgery

Randomized Clinical Trial to Compare the Efficacy of Opioid-free Vs Traditional Balanced Anesthesia in Laparoscopic Colorectal Surgery

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Unai Ortega Mera · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to compare opioid free anesthesia versus opioid anesthesia in patients undergo laparoscopic colorectal surgery. The main question it aims to answer is assess the efficacy of opioid-free anaesthesia respect to postoperative pain control in patients undergoing a laparoscopic colorectal surgery. Participants will answer a questionnaire during the first 3 days of admission, assessing pain through the visual analog scale (VAS). The researchers will compare the consumption of opiates during the postoperative period in the opioid-free anesthesia group.

Detailed description

The objective of the study is to know the efficacy of OFA in laparoscopic colorectal surgery. The consumption of opiates will be evaluated according to the VAS scale, defining non-tolerable pain greater than 5. The number of rescues required, the time elapsed until the first rescue and the total consumption of opiates administered will be evaluated. Other variables that will be evaluated will be safety variables defined as intraoperative complications that require immediate action by the anesthesiologist, interruption of the procedure, or conversion to open surgery. Other variables evaluated will be postoperative complications: * Postoperative hypoxemia. * Incidence of postoperative nausea and vomiting (PONV). * Postoperative ileus. * surgical complications. * medical complications

Conditions

• Colorectal Surgery

Interventions

Type	Name	Description
DRUG	Opioid free anesthesia	It administers a combination of drugs to replace the opioid derivatives. Among them, we will use lidocaine, ketamine, dexmetomidine, and magnesium sulfate in continuous infusion adjusted to the patient's weight during surgery.
DRUG	Opioid based Anesthesia	administer anesthesia based on opioids such as fentanyl and/or morphine to guarantee analgesia during the surgical intervention.

Timeline

• Start date: 2022-05-15
• Primary completion: 2024-05-15
• Completion: 2024-06-15
• First posted: 2023-06-02
• Last updated: 2024-10-30

Locations

1 site across 1 country: Spain