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

NCT ID: NCT04854993

Last Updated: 2023-01-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-13
• Study Completion Date: 2022-09-23

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).

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.

Conditions

Prostate Cancer; Neuromuscular Blockade

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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

Group Type: EXPERIMENTAL

Sugammadex 6 mg/kg

Intervention Type: DRUG

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

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

Group Type: ACTIVE_COMPARATOR

Sugammadex 4 mg/kg

Intervention Type: DRUG

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

Interventions

Sugammadex 6 mg/kg

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

Intervention Type: DRUG

Sugammadex 4 mg/kg

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

Intervention Type: DRUG

Other Intervention Names

MK-8616; MK-8616

Eligibility Criteria

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Paola Aceto, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Locations

Fondazione Policlinico Universitario A. Gemelli IRCCS

Rome, , Italy

Countries

Italy

Other Identifiers

2020-004704-34

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

3764

Identifier Type: -

Identifier Source: org_study_id