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

• Status: Not yet recruiting
• Trial end date: 2022-11-01
• Target enrollment: 0
• Participant gender: Male

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Criteria

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