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

Fondazione Policlinico Universitario Agostino Gemelli IRCCS34 enrolled

Overview

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).

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Eligibility

Sex: MALEMin age: 65 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Neuromuscular recovery time

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

Time frame: 5 minutes

Secondary Outcomes

Time to extubation

Time from neuromuscular reversal (TOF=1) to extubation

Time frame: 10 minutes

Time to OR exit

Time from neuromuscular reversal (TOF=1) to exit from the operating room

Time frame: 30 minutes

PACU length of stay

Duration of stay in the post-anaesthesia care unit

Time frame: 2 hours

Hemodynamic parameters

Non-invasive blood pressure (mmHg) and heart rate (beats per minute) after sugammadex administration

Time frame: 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

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