Opioid-free Vs Traditional Balanced Anesthesia in Laparoscopic Colorectal Surgery

NCT05887258 | Completed Phase 3

• 1 other identifier: 2021-003245-38
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Surgery

Outcome Measures

Primary Outcomes (1)

• Pain control

  milligrams of opioids required postoperatively during the first 3 of admission

  3 days

Secondary Outcomes (2)

• VNS score

  3 days

• morphine rescues

  7 days

Other Outcomes (2)

• intraoperative Security

  1 day

• postoperative security

  3 day

Study Arms (2)

Opioid free anesthesia (OFA)

EXPERIMENTAL

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

Opioid based Anesthesia (OA)

ACTIVE COMPARATOR

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

Interventions

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.

Also known as: OFA

Opioid free anesthesia (OFA)

Opioid based Anesthesia DRUG

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

Also known as: Traditional anesthesia

Opioid based Anesthesia (OA)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ( - ) 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

You may not qualify if:

• (-) 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.

Sponsors & Collaborators

• Unai Ortega Mera: lead
• Osakidetza: collaborator

Study Sites (1)

Hospital de Galdakao

Galdakao, Vizcaya, 48960, Spain

Location

Study Officials

• Unai Ortega, MD

  Osakidetza

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 16, 2023
• First Posted: June 2, 2023
• Study Start: May 15, 2022
• Primary Completion: May 15, 2024
• Study Completion: June 15, 2024
• Last Updated: October 30, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)