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Completed

NCT Number: NCT05887258

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.

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Key information

Conditions

Colorectal Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hospital de Galdakao

Galdakao, Vizcaya, 48960, Spain

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

opioid free anesthesia

Drug

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

Opioid based Anesthesia

Drug

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

Other names: Traditional anesthesia

Primary outcomes

  1. Pain control

    Time frame: 3 days

    milligrams of opioids required postoperatively during the first 3 of admission

Secondary outcomes

  1. VNS score

    Time frame: 3 days

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

  2. morphine rescues

    Time frame: 7 days

    Number of opiate rescues required during the postoperative period

Other outcomes

  1. intraoperative Security

    Time frame: 1 day

    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.

  2. postoperative security

    Time frame: 3 day

    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

Sponsors and collaborators

Lead sponsor

Unai Ortega Mera

Other

Collaborators

  • Osakidetza

Registry information

Official study title

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

Acronym: OFA_GAL_21

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jun 2, 2023
Registry last updated
Oct 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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