NCT03519633

Role of Curarization During Anesthesia for Laparoscopic Hysterectomy

The Role of Deep Neuromuscular Blockade and Sugammadex in Laparoscopic Hysterectomy: A Randomized Controlled Trial

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 238 (actual)
• 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 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.

Conditions

• Curarization, Postoperative Residual
• Postoperative Pain Of Laparoscopic Surgery
• PONV

Interventions

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

Timeline

• Start date: 2018-04-01
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2018-05-09
• Last updated: 2025-04-10

Locations

1 site across 1 country: Italy