Effectiveness comparative study of two anesthetic techniques commonly used in patients undergoing gallbladder surgical removal.

Phase 1

• Conditions: Elective cholecystectomy; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2020-000732-22-ES
• Lead Sponsor: Pablo Rama Maceiras

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-05-25
• Last Update Posted: 30 November 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

(1) Age between 18 and 85 years.

(2) Laparoscopic elective cholecystectomy intervention with planned hospital admission.

(3) ?ASA Physical Status Classification System < IV
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 23
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 23

Exclusion Criteria

(1) Patient refusal
(2) known hypersensitivity to any of the medications used in this study
(3) opiates chronic use
(4) epilepsy
(5) psychomotor delay
(6) morbid obesity (defined as BMI> 40)
(7) obstructive sleep apnea syndrome
(8) presence of a heart rhythm block that requires a pacemaker implant
(9) liver failure (defined as total preoperative serum bilirubin > 2 mg / dl)
(10) renal insufficiency (defined as estimated renal glomerular filtration rate = 50 ml / min / 1.73 m2)
(11) pregnancy
(12) local skin infection at the puncture site level

Study & Design

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