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

NCT04854993 | Completed Phase 3

• 2 other identifiers: 37642020-004704-34
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Prostate Cancer; Neuromuscular Blockade

Keywords

sugammadex; elderly; recovery time; robotic surgery

Outcome Measures

Primary Outcomes (1)

• Neuromuscular recovery time

  Time from the end of sugammadex administration to train-of-four (TOF)=1

  5 minutes

Secondary Outcomes (5)

• Time to extubation

  10 minutes

• Time to OR exit

  30 minutes

• PACU length of stay

  2 hours

• Hemodynamic parameters

  up to discharge from post-anaesthesia care unit, an average of 2 hours

• Respiratory function

  up to discarge from post-anaesthesia care unit, an average of 2 hours

Study Arms (2)

Increased dose of sugammadex

EXPERIMENTAL

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

Standard dose of sugammadex

ACTIVE COMPARATOR

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

Interventions

Sugammadex 6 mg/kg DRUG

i.v. injection of an increased (by 50%) dose of sugammadex to reverse dNMB

Also known as: MK-8616

Increased dose of sugammadex

Sugammadex 4 mg/kg DRUG

i.v. injection of a standard dose of sugammadex to reverse dNMB

Also known as: MK-8616

Standard dose of sugammadex

Eligibility Criteria

• Age: 65 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario A. Gemelli IRCCS

Rome, 00168, Italy

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Sugammadex

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

gamma-Cyclodextrins; Cyclodextrins; Macrocyclic Compounds; Polycyclic Compounds; Dextrins; Starch; Glucans; Polysaccharides; Carbohydrates

Study Officials

• Paola Aceto, MD, PhD

  Fondazione Policlinico Universitario Agostino Gemelli IRCCS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The patient as well as the investigator (care provider) who will administer the different blinded sugammadex dosage and collect postoperative data will be blinded to the group allocation. The randomization and preparation of the drug will be performed by the unblinded staff of hospital experimental pharmacy who will carry out the randomization with a 1: 1 ratio and will assign the different dose to each patient. The drug will be prepared in a shielded pre-filled syringe in order to maintain blindness. In case of emergency, the pharmacy staff will immediately open the randomization code of interest disclosing the group assignment (sugammadex dose).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2021
• First Posted: April 22, 2021
• Study Start: July 13, 2021
• Primary Completion: September 20, 2022
• Study Completion: September 23, 2022
• Last Updated: January 25, 2023

Record last verified: 2022-01

Locations

IT (1)