Role of Curarization During Anesthesia for Gynecologic Surgical Laparotomy Procedures

Campus Bio-Medico University of Rome

Status and phase

Unknown

Phase 2

Conditions

Curarization, Postoperative Residual

Treatments

Drug: Sugammadex

Drug: Neostigmine

Study type

Interventional

Funder types

Other

Identifiers

NCT03519724

GYN LPTM-CUR 2018

Details and patient eligibility

About

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

Enrollment

100 estimated patients

Sex

Female

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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