Randomized clinical trial to compare the efficacy of opioid-free versus traditional balanced anesthesia in laparoscopic colorectal surgery

Phase 1

• Conditions: laparoscopic colorectal surgery; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]

• Registration Number: EUCTR2021-003245-38-ES
• Lead Sponsor: nai Ortega Mera

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-11-10
• Last Update Posted: 14 March 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 164

Inclusion Criteria

? Patients aged 18 years or older.
? Patients with scheduled laparoscopic colorectal surgery.
? Patients with physical status classification (ASA) I-III.
? Patients who have signed the informed consent for the clinical trial
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 164
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

? Pregnant or lactating patients.
? Patients with an allergy to any of the drugs or excipients used in the study.
? Emergency laparoscopic colorectal surgery.
? Patients with physical status classification (ASA) IV.
? Patients with AV block, intraventricular or sinus block.
? Adam-Stokes syndrome.
? Patient on chronic beta-blockers treatment with HR <50 bpm.
? Patient with known ejection fraction <40%.
? Epilepsy.
? Chronic opioid user.
? Surgery converted to open surgery.
? Legally disabled patient.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified