Opioid-free Vs Traditional Balanced Anesthesia in Laparoscopic Colorectal Surgery

Phase 3

Completed

• Conditions: Colorectal Surgery
• Interventions: Drug: Opioid free anesthesia; Drug: Opioid based Anesthesia

• Registration Number: NCT05887258
• Lead Sponsor: Unai Ortega Mera

Brief 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

Study Timeline

• Study Start: 2022-05-15
• Study First Submitted: 2023-04-16
• Study First Submitted QC: 2023-05-31
• Study First Posted: 2023-06-02
• Primary Completion: 2024-05-15
• Study Completion: 2024-06-15
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-27
• Last Update Posted: 2024-10-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

( - ) Patients older than or equal to 18 years.

(-) Patients scheduled for laparoscopic colorectal surgery.

(-) Patients with physical status classification (ASA) I-III.

(- ) Patients who have signed the informed consent of the clinical trial

Exclusion Criteria

(-) Pregnant or lactating patients.

(-)Patients with allergy to any of the drugs or excipients used in the study

(-) Emergency laparoscopic colorectal surgery

(-) Patients with AV block, intraventricular block, or sinus block

(-) Adam-Stokes syndrome.

(-) Patient on chronic beta-blocker treatment with HR < 50 bpm

(-) Patient with ejection fraction < 40% known

(-) Epilepsy.

(-) Surgery converted to open surgery

(-) Legally disabled patient

(-) Patients with physical status classification (ASA) IV.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Opioid free anesthesia (OFA)	Opioid free anesthesia	This arm is administered by the anesthesiologist in charge of the operating room. It is composed by Dexmedetomidine (Dexdor), Lidocaine, Magnesium Sulfate and ketamine (Ketolar).
Opioid based Anesthesia (OA)	Opioid based Anesthesia	This arm is administered by the anesthesiologist in charge of the operating room. This arm is composed of Remifentanil hydrochloride and postoperative rescue analgesia will be morphine.

Primary Outcome Measures

Name	Time	Method
Pain control	3 days	milligrams of opioids required postoperatively during the first 3 of admission

Secondary Outcome Measures

Name	Time	Method
VNS score	3 days	Pain measured through the visual analogue scale (VAS) during the first 3 days of admission
morphine rescues	7 days	Number of opiate rescues required during the postoperative period

Trial Locations

Locations (1)

Hospital de Galdakao; 🇪🇸 Galdakao, Vizcaya, Spain