Clinical trial NCT04854993: Recovery From dNMB Using Different Sugammadex Doses in Elderly Patients Undergoing Robot-assisted Prostatectomy
Official title: Recovery From Deep Neuromuscular Blockade Using Different Sugammadex Doses in Elderly Patients Undergoing Laparoscopic Robot-assisted Prostatectomy: a Prospective, Randomized, Double-blind Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Prostate Cancer
Neuromuscular Blockade
Keywords: sugammadex
elderly
recovery time
robotic surgery
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2021-04-22
Enrollment: 34
Sex: MALE
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Neuromuscular recovery time
timeFrame: 5 minutes
Secondary outcomes:
measure: Time to extubation
timeFrame: 10 minutes
measure: Time to OR exit
timeFrame: 30 minutes
measure: PACU length of stay
timeFrame: 2 hours
measure: Hemodynamic parameters
timeFrame: up to discharge from post-anaesthesia care unit, an average of 2 hours
measure: Respiratory function
timeFrame: up to discarge from post-anaesthesia care unit, an average of 2 hours
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Fondazione Policlinico Universitario A. Gemelli IRCCS
Study officials:
affiliation: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
name: Paola Aceto, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: