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

Unai Ortega Mera

Status and phase: Completed; Phase 3

Conditions: Colorectal Surgery

Treatments: Drug: Opioid based Anesthesia; Drug: Opioid free anesthesia

Study type: Interventional

Funder types: Other

Identifiers

NCT05887258

2021-003245-38

Details and patient eligibility

About

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.

Full 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

Enrollment: 120 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 2 patient groups

Opioid free anesthesia (OFA)

Experimental group

Description:

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).

Treatment:

Drug: Opioid free anesthesia

Opioid based Anesthesia (OA)

Active Comparator group

Description:

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.

Treatment:

Drug: Opioid based Anesthesia