Curarization, Postoperative Residual, PONV, Postoperative Pain Of Laparoscopic Surgery
Conditions
Keywords
deep neuromuscular blockade, sugammadex, postoperative pain, laparoscopic hysterectomy
Brief summary
The primary outcome of this study is to investigate whether deep NMB reversed with Sugammadex is superior to moderate NMB reversed with Neostigmine, in terms of overall pain in the first 48 hrs after laparoscopic hysterectomy, reversal time from NMB (TOF≥0.9) and direct and indirect costs. Additionally we will also assess: drugs consumption for pain and antiemetics (rescue dose), surgical conditions, hemodynamic and respiratory stability, operation time, anesthesia time, total amount and flow rate of CO2, insufflation time, resolution of post-operative ileus, dry mouth and PONV in the first 48 hours, patient satisfaction.
Interventions
DRUGSugammadex
Reversal of deep NMB
DRUGNeostigmine
Reversal of moderate NMB
Sponsors
Campus Bio-Medico University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
Anesthesiologists were aware of the treatment assignment, while the surgeon and surgical staff were blinded. Additionally, patients, nurses/doctors assessing outcomes, and the statistician were blinded
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Age 18-75 years BMI between 16 and 40 Kg/m2 ECOG Performance Status tra 0 e 1 American Society Anesthesiologist (ASA) class 1 or 3 Able to provide informed consent to trial procedures
Exclusion criteria
* Age \< 18 or \> 75 years * BMI \<16 o \> 40 Kg/m2 * ECOG Performance Status \>1 * Pregnancy * Active or recent pelvic inflammation * Anticipated airway difficulty * Patients with history of allergy to rocuronium, neostigmine or sugammadex * Allergy to NSAIDs * Previous opioids consumption for chronic pain * Patients receiving drugs for different medical conditions, that may prolong or shorten the duration of rocuronium effect (e.g aminoglycosides, magnesium) * Hepatic or renal failure * Persistent coagulopathy * Neurological or cognitive disorders * Conversion from laparoscopic to open surgery Onset of intraoperative complications
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall pain in the first 24 hrs after gynecologic surgical procedures | First 48 hrs after gynecologic surgical procedures | 0-10 NRS |
| Recovery time (or Reversal time) from NMB (TOF≥0.9) | Recovery time (or Reversal time) from NMB (TOF≥0.9) will be measured after the administration of reversal agent at the end of the surgical procedure. | Recovery time (or Reversal time) from NMB (TOF≥0.9), measured in minutes from to administration of reversal agent to a TOF≥0.9 |
Countries
Italy
Outcome results
None listed