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

Prostate Cancer Clinical Trial

— RECIR  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04854993
• Other study ID #: 3764
• Secondary ID: 2020-004704-34
• Status: Completed
• Phase: Phase 3
• Start date: July 13, 2021
• Est. completion date: September 23, 2022

Study information

• Verified date: January 2022
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: September 23, 2022
• Est. primary completion date: September 20, 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neuromuscular Blockade
• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Sugammadex 6 mg/kg
i.v. injection of an increased (by 50%) dose of sugammadex to reverse dNMB
• Sugammadex 4 mg/kg
i.v. injection of a standard dose of sugammadex to reverse dNMB

Locations

Country	Name	City	State
Italy	Fondazione Policlinico Universitario A. Gemelli IRCCS	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neuromuscular recovery time	Time from the end of sugammadex administration to train-of-four (TOF)=1	5 minutes
Secondary	Time to extubation	Time from neuromuscular reversal (TOF=1) to extubation	10 minutes
Secondary	Time to OR exit	Time from neuromuscular reversal (TOF=1) to exit from the operating room	30 minutes
Secondary	PACU length of stay	Duration of stay in the post-anaesthesia care unit	2 hours
Secondary	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
Secondary	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