Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neuromuscular Blockade | — | UNRESOLVED | — |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sugammadex 4 mg/kg | Drug | — | UNRESOLVED |
| Sugammadex 6 mg/kg | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Increased dose of sugammadex
- description
- A dose of 6 mg/kg of sugammadex will be given intravenously for deep neuromuscular block reversal at the end of surgery
- interventionNames
- Drug: Sugammadex 6 mg/kg
- type
- ACTIVE_COMPARATOR
- label
- Standard dose of sugammadex
- description
- A dose of 6 mg/kg of sugammadex will be given intravenously for deep neuromuscular block reversal at the end of surgery
- interventionNames
- Drug: Sugammadex 4 mg/kg
Primary outcomes (1)
- measure
- Neuromuscular recovery time
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 65 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available