Role of Curarization During Anesthesia for Gynecologic Surgical Laparotomy Procedures

• Status: Unknown status
• Trial end date: 2019-01-30
• Target enrollment: 0
• Participant gender: Female

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 gynecologic surgery, 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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Campus Bio-Medico University
• Treatments: Neostigmine

Criteria

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