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

Institute of Hospitalization and Scientific Care (IRCCS)

Status and phase: Completed; Phase 3

Conditions: Prostate Cancer; Neuromuscular Blockade

Treatments: Drug: Sugammadex 6 mg/kg; Drug: Sugammadex 4 mg/kg

Study type: Interventional

Funder types: Other

Identifiers

NCT04854993

2020-004704-34 (EudraCT Number)

3764

Details and patient eligibility

About

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).

Full 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.

Enrollment: 34 patients

Sex: Male

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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34 participants in 2 patient groups

Increased dose of sugammadex

Experimental group

Description:

A dose of 6 mg/kg of sugammadex will be given intravenously for deep neuromuscular block reversal at the end of surgery

Treatment:

Drug: Sugammadex 6 mg/kg

Standard dose of sugammadex

Active Comparator group

Description:

A dose of 6 mg/kg of sugammadex will be given intravenously for deep neuromuscular block reversal at the end of surgery

Treatment:

Drug: Sugammadex 4 mg/kg