Recovery From dNMB Using Different Sugammadex Doses in Elderly Patients Undergoing Robot-assisted Prostatectomy
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Neuromuscular Blockade
- Prostate Cancer
- Type
- Interventional
- Phase
- Phase 3
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Masking Description: The patient as well as the investigator (care provider) who will administer the different blinded sugammadex dosage and collect postoperative data will be blinded to the group allocation. The randomization and preparation of the drug will be performed by the unblinded staff of hospital experimental pharmacy who will carry out the randomization with a 1: 1 ratio and will assign the different dose to each patient. The drug will be prepared in a shielded pre-filled syringe in order to maintain blindness. In case of emergency, the pharmacy staff will immediately open the randomization code of interest disclosing the group assignment (sugammadex dose).Primary Purpose: Treatment
Participation Requirements
- Age
- Between 65 years and 125 years
- Gender
- Only males
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 a...
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.
Tracking Information
- NCT #
- NCT04854993
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Paola Aceto, MD, PhD Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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