Opioid-free Vs Traditional Balanced Anesthesia in Laparoscopic Colorectal Surgery

Unai Ortega Mera120 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

120

Conditions

Colorectal Surgery

Interventions

Opioid free anesthesiaDRUG

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.

Opioid based AnesthesiaDRUG

administer anesthesia based on opioids such as fentanyl and/or morphine to guarantee analgesia during the surgical intervention.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Hospital de Galdakao

Galdakao, Vizcaya, Spain

Outcomes

Primary Outcomes

Pain control

milligrams of opioids required postoperatively during the first 3 of admission

Time frame: 3 days

Secondary Outcomes

VNS score

Pain measured through the visual analogue scale (VAS) during the first 3 days of admission

Time frame: 3 days

morphine rescues

Number of opiate rescues required during the postoperative period

Time frame: 7 days

Data from ClinicalTrials.gov

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