Role of Curarization During Anesthesia for Gynecologic Surgical Laparotomy Procedures

Phase 2

• Conditions: Curarization, Postoperative Residual
• Interventions: Drug: Sugammadex; Drug: Neostigmine

• Registration Number: NCT03519724
• Lead Sponsor: Campus Bio-Medico University

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 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-03-09
• Study First Submitted QC: 2018-04-26
• Study First Posted: 2018-05-09
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-09
• Last Update Posted: 2018-07-10
• Study Start: 2018-07-30
• Primary Completion: 2018-09-30
• Study Completion: 2019-01-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SUG	Sugammadex	-
NEO	Neostigmine	-

Primary Outcome Measures

Name	Time	Method
Overall pain in the first 48 hrs after gynecologic surgical procedures	First 48 hrs after gynecologic surgical procedures	0 - 10 NRS scale of the overall pain in the first 48 hrs after gynecologic surgical procedures
Recovery time (or Reversal time) from NMB (TOF≥0.9)	The recovery time (or Reversal time) will be measured in minutes after the administration of reversal agent at the end of the surgical procedure	The recovery time (or Reversal time) will be measured in minutes from the administration of reversal agent to a TOF≥0.9

Trial Locations

Locations (1)

Campus Bio-medico; 🇮🇹 Roma, RM, Italy