Status:
COMPLETED
Recovery From dNMB Using Different Sugammadex Doses in Elderly Patients Undergoing Robot-assisted Prostatectomy
Lead Sponsor:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Conditions:
Prostate Cancer
Neuromuscular Blockade
Eligibility:
MALE
65+ years
Phase:
PHASE3
Brief 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 pa...
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 ...
Eligibility Criteria
Inclusion
- patient's age ≥65years
- prostate cancer
- robot-assisted laparoscopic radical prostatectomy (RALP)
Exclusion
- 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
Key Trial Info
Start Date :
July 13 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 23 2022
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT04854993
Start Date
July 13 2021
End Date
September 23 2022
Last Update
January 25 2023
Active Locations (1)
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1
Fondazione Policlinico Universitario A. Gemelli IRCCS
Rome, Italy, 00168