NCT03519724

Role of Curarization During Anesthesia for Gynecologic Surgical Laparotomy Procedures

The Role of Curarization During Anesthesia for Gynecologic Laparotomy Surgical Procedures: a Double Blind Randomized Controlled Trial

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Campus Bio-Medico University · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Conditions

• Curarization, Postoperative Residual

Interventions

Type	Name	Description
DRUG	Sugammadex	Reversal of deep NMB
DRUG	Neostigmine	Reversal of moderate NMB

Timeline

• Start date: 2018-07-30
• Primary completion: 2018-09-30
• Completion: 2019-01-30
• First posted: 2018-05-09
• Last updated: 2018-07-10

Locations

1 site across 1 country: Italy