Opioid-free Vs Traditional Balanced Anesthesia in Laparoscopic Colorectal Surgery (OFA_GAL_21)

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

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Surgery
• Intervention / Treatment: Drug: Opioid free anesthesia; Drug: Opioid based Anesthesia

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 Type: Interventional
• Enrollment (Actual): 120
• Phase: Phase 3

Contacts and Locations

Study Locations

• Spain
  • Vizcaya
    • Galdakao, Vizcaya, Spain, 48960
      • Hospital de Galdakao

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Opioid free anesthesia (OFA); 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).	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.; Other Names: OFA
Active Comparator: Opioid based Anesthesia (OA); 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.	Drug: Opioid based Anesthesia; administer anesthesia based on opioids such as fentanyl and/or morphine to guarantee analgesia during the surgical intervention.; Other Names: Traditional anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain control	milligrams of opioids required postoperatively during the first 3 of admission	3 days

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
intraoperative Security	Presentation of complications during the surgical intervention defined as a situation that requires immediate action by the anesthetist and lasts more than 30 minutes, the interruption of the operation and/or conversion to open surgery.	1 day
postoperative security	Operative hypoxemia defined as oxygen saturation by pulseoximetry less than 90% Incidence of Postoperative Nausea and Vomiting (PONV) during de first 3 days Postoperative ileus defined as the absence of bowel movements during the first 3 days	3 day

Collaborators and Investigators

• Sponsor: Unai Ortega Mera
• Collaborators: Osakidetza
• Investigators: Principal Investigator: Unai Ortega, MD, Osakidetza

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2022
• Primary Completion (Actual): May 15, 2024
• Study Completion (Actual): June 15, 2024

Study Registration Dates

• First Submitted: April 16, 2023
• First Submitted That Met QC Criteria: May 31, 2023
• First Posted (Actual): June 2, 2023

Study Record Updates

• Last Update Posted (Actual): October 30, 2024
• Last Update Submitted That Met QC Criteria: October 27, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Peripheral Nervous System Agents; Central Nervous System Depressants; Sensory System Agents; Analgesics; Narcotics; Analgesics, Opioid; Anesthetics
• Other Study ID Numbers: 2021-003245-38

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No