Recovery From dNMB Using Different Sugammadex Doses in Elderly Patients Undergoing Robot-assisted Prostatectomy (RECIR)

Recovery From Deep Neuromuscular Blockade Using Different Sugammadex Doses in Elderly Patients Undergoing Laparoscopic Robot-assisted Prostatectomy: a Prospective, Randomized, Double-blind Clinical Trial

The aim of this prospecive randomized study is to evaluate the effects of a dose of sugammadex increased by 50% compared to a standard dose on recovery time from deep neuromuscular block in elderly patients undergoing robot-assisted laparoscopic radical prostatectomy (RALP). Secondary objectives are to evaluate the different extubation time, time to exit from the operating room (OR), lenght of stay in post-anaesthesia care unit (PACU) and safety (hemodynamic parameters and respiratory function).

Study Overview

• Status: Completed
• Conditions: Prostate Cancer; Neuromuscular Blockade
• Intervention / Treatment: Drug: Sugammadex 6 mg/kg; Drug: Sugammadex 4 mg/kg

Detailed Description

An increasing percentage of elderly patients with localized prostate cancer undergo RALP, due to the higher safety and feasibility of this minimally invasive surgical option compared to standard open procedure. This procedure is performed under deep neuromuscular block (dNMB) in order to guarantee an adequate working space. Induction and maintenance of the dNMB require neuromuscular monitoring and adequate reversal at the end of the intervention to prevent postoperative residual curarization (PORC). Sugammadex is the most attractive strategy to titrate reversal according to NMB monitoring data and to ensure a complete recovery of muscle function before extubation. In elderly patients, the risk of PORC and related postoperative complications is higher. For these reasons, we hypothesize that a dose of sugammadex increased by 50% compared to a standard dose could significantly shorten neuromuscular recovery time, extubation time, OR discharge time and PACU length of stay in elderly patients undergoing RALP.

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Paola Aceto, MD, PhD; Phone Number: +39630154507; Email: paola.aceto@policlinicogemelli.it

Study Locations

• Italy
  • Rome, Italy, 00168
    • Fondazione Policlinico Universitario A. Gemelli IRCCS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• patient's age ≥65years
• prostate cancer
• robot-assisted laparoscopic radical prostatectomy (RALP)

Exclusion Criteria:

• inability to obtain written informed consent
• history of significant liver, renal or pulmonary diseases
• current smoking
• chronic or acute alcoholism
• known or suspected neuromuscular disorders
• family history of malignant hyperthermia
• any pre-existing coagulopathy
• abnormal blood coagulation tests (including prothrombin time <70%; activated partial thromboplastin time >38 seconds and INR >1.20) or preoperative anticoagulant therapies
• BMI ≥30 Kg/m2
• known allergy or hypersensitivity to the drugs used in the study
• planned postoperative admission to intensive care unit.
• moderate neuromuscular block (TOF 1-3) at the end of surgery

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Increased dose of sugammadex; A dose of 6 mg/kg of sugammadex will be given intravenously for deep neuromuscular block reversal at the end of surgery	Drug: Sugammadex 6 mg/kg; i.v. injection of an increased (by 50%) dose of sugammadex to reverse dNMB; Other Names: MK-8616
Active Comparator: Standard dose of sugammadex; A dose of 6 mg/kg of sugammadex will be given intravenously for deep neuromuscular block reversal at the end of surgery	Drug: Sugammadex 4 mg/kg; i.v. injection of a standard dose of sugammadex to reverse dNMB; Other Names: MK-8616

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neuromuscular recovery time	Time from the end of sugammadex administration to train-of-four (TOF)=1	5 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to extubation	Time from neuromuscular reversal (TOF=1) to extubation	10 minutes
Time to OR exit	Time from neuromuscular reversal (TOF=1) to exit from the operating room	30 minutes
PACU length of stay	Duration of stay in the post-anaesthesia care unit	2 hours
Hemodynamic parameters	Non-invasive blood pressure (mmHg) and heart rate (beats per minute) after sugammadex administration	up to discharge from post-anaesthesia care unit, an average of 2 hours
Respiratory function	Peripheral oxygen saturation (percentage) and respiratory rate (breaths per minute) after sugammadex administration	up to discarge from post-anaesthesia care unit, an average of 2 hours

Collaborators and Investigators

• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Investigators: Principal Investigator: Paola Aceto, MD, PhD, Fondazione Policlinico Universitario Agostino Gemelli Irccs

Study record dates

Study Major Dates

• Study Start (Actual): July 13, 2021
• Primary Completion (Actual): September 20, 2022
• Study Completion (Actual): September 23, 2022

Study Registration Dates

• First Submitted: April 14, 2021
• First Submitted That Met QC Criteria: April 20, 2021
• First Posted (Actual): April 22, 2021

Study Record Updates

• Last Update Posted (Estimate): January 25, 2023
• Last Update Submitted That Met QC Criteria: January 24, 2023
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: elderly; robotic surgery; sugammadex; recovery time
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: 3764; 2020-004704-34 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No