Prostate Cancer, Neuromuscular Blockade
Conditions
Keywords
sugammadex, elderly, recovery time, robotic surgery
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 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.
Interventions
DRUGSugammadex 6 mg/kg
i.v. injection of an increased (by 50%) dose of sugammadex to reverse dNMB
i.v. injection of a standard dose of sugammadex to reverse dNMB
Sponsors
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, 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).
Eligibility
Sex/Gender
MALE
Age
65 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Neuromuscular recovery time | 5 minutes | Time from the end of sugammadex administration to train-of-four (TOF)=1 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to extubation | 10 minutes | Time from neuromuscular reversal (TOF=1) to extubation |
| Time to OR exit | 30 minutes | Time from neuromuscular reversal (TOF=1) to exit from the operating room |
| PACU length of stay | 2 hours | Duration of stay in the post-anaesthesia care unit |
| Hemodynamic parameters | up to discharge from post-anaesthesia care unit, an average of 2 hours | Non-invasive blood pressure (mmHg) and heart rate (beats per minute) after sugammadex administration |
| Respiratory function | up to discarge from post-anaesthesia care unit, an average of 2 hours | Peripheral oxygen saturation (percentage) and respiratory rate (breaths per minute) after sugammadex administration |
Countries
Italy
Outcome results
None listed