NCT04854993

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Academic / Other
• Sex: Male
• Age: 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Prostate Cancer
• Neuromuscular Blockade

Interventions

Type	Name	Description
DRUG	Sugammadex 6 mg/kg	i.v. injection of an increased (by 50%) dose of sugammadex to reverse dNMB
DRUG	Sugammadex 4 mg/kg	i.v. injection of a standard dose of sugammadex to reverse dNMB

Timeline

• Start date: 2021-07-13
• Primary completion: 2022-09-20
• Completion: 2022-09-23
• First posted: 2021-04-22
• Last updated: 2023-01-25

Locations

1 site across 1 country: Italy