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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Recovery From Deep Neuromuscular Blockade Using Different Sugammadex Doses in Elderly Patients Undergoing Laparoscopic Robot-assisted Prostatectomy: a Prospective, Randomized, Double-blind Clinical Trial

Conditions
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Prostate Cancer, Neuromuscular Blockade

Intervention / Treatment
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* Drug: Sugammadex 6 mg/kg
* Drug: Sugammadex 4 mg/kg


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Increased dose of sugammadex<br>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<br>* i.v. injection of an increased (by 50%) dose of sugammadex to reverse dNMB<br>* Other names: MK-8616;|
| Active Comparator: Standard dose of sugammadex<br>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<br>* i.v. injection of a standard dose of sugammadex to reverse dNMB<br>* Other names: MK-8616;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neuromuscular recovery time | Time from the end of sugammadex administration to train-of-four (TOF)=1 | 5 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to extubation | Time from neuromuscular reversal (TOF=1) to extubation | 10 minutes | 
| Time to OR exit | Time from neuromuscular reversal (TOF=1) to exit from the operating room | 30 minutes | 
| PACU length of stay | Duration of stay in the post-anaesthesia care unit | 2 hours | 
| Hemodynamic parameters | Non-invasive blood pressure (mmHg) and heart rate (beats per minute) after sugammadex administration | 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 | up to discarge from post-anaesthesia care unit, an average of 2 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sugammadex, elderly, recovery time, robotic surgery