Recovery from deep neuromuscular blockade using different sugammadex doses in elderly patients undergoing laparoscopic robot-assisted prostatectomy: a prospective, randomized, double-blind clinical trial (RECIR)

Phase 1

• Conditions: Deep neuromuscular block in patients undergoing RALP under general anaesthesia; MedDRA version: 21.1Level: PTClassification code 10057286Term: Neuromuscular blockade reversalSystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2020-004704-34-IT
• Lead Sponsor: FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS UNIVERSITA' CATTOLICA DEL SACRO CUORE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-05-24
• Last Update Posted: 11 September 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 34

Inclusion Criteria

patient’s age =65years, robot-assisted laparoscopic radical prostatectomy (RALP).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 34

Exclusion Criteria

Inability to obtain written informed consent, history of significant liver or renal diseases, chronic or acute alcoholism, known or suspected neuromuscular disorders, a family history of malignant hyperthermia, BMI =30 Kg/m2, known allergy or hypersensitivity to drugs used, or planned admission to postoperative intensive care unit. Patients showing moderate neuromuscular block (TOF count=1-3) will be excluded from the study. (pag 5 protocol)

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: The aim of this prospective, double-blind, single center randomized study will be to evaluate the effects of a dose of sugammadex increased by 50% compared with standard dose on recovery time from deep neuromuscular block (primary outcome) in the elderly patients undergoing robot-assisted laparoscopic radical prostatectomy (RALP).;Secondary Objective: Secondary objectives will be to evaluate difference in: 1. extubation time; 2. time to exit from the OR; and 3. post-anaesthesia care unit (PACU) length of stay.;Primary end point(s): Primary endpoint will be neuromuscular recovery time (primary outcome): time from the end of sugammadex administration to TOF=1.;Timepoint(s) of evaluation of this end point: 5 MINUTES

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Secondary endpoints will be: <br>1. time from neuromuscular reversal (TOF=1) to extubation; <br>2. time from neuromuscular reversal (TOF=1) to exit from the OR; <br>3. PACU length of stay.;Timepoint(s) of evaluation of this end point: 1. 10 MINUTES<br>2. 30 MINUTES<br>3. 2 HOURS