Fondazione Policlinico Universitario A. Gemelli IRCCS
Rome, 00168, Italy
NCT Number: NCT04854993
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).
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Notify Me65 year and older
Male
Interventional
Phase 3
Rome, 00168, Italy
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
i.v. injection of an increased (by 50%) dose of sugammadex to reverse dNMB
Other names: MK-8616
i.v. injection of a standard dose of sugammadex to reverse dNMB
Other names: MK-8616
Time frame: 5 minutes
Time from the end of sugammadex administration to train-of-four (TOF)=1
Time frame: 10 minutes
Time from neuromuscular reversal (TOF=1) to extubation
Time frame: 30 minutes
Time from neuromuscular reversal (TOF=1) to exit from the operating room
Time frame: 2 hours
Duration of stay in the post-anaesthesia care unit
Time frame: up to discharge from post-anaesthesia care unit, an average of 2 hours
Non-invasive blood pressure (mmHg) and heart rate (beats per minute) after sugammadex administration
Time frame: up to discarge from post-anaesthesia care unit, an average of 2 hours
Peripheral oxygen saturation (percentage) and respiratory rate (breaths per minute) after sugammadex administration
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Other
Recovery From Deep Neuromuscular Blockade Using Different Sugammadex Doses in Elderly Patients Undergoing Laparoscopic Robot-assisted Prostatectomy: a Prospective, Randomized, Double-blind Clinical Trial
Acronym: RECIR
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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