Role of Curarization During Anesthesia for Gynecologic Surgical Laparotomy Procedures

Phase 2UnknownNCT03519724

Campus Bio-Medico University100 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

100

Conditions

Curarization, Postoperative Residual

Interventions

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Overall pain in the first 48 hrs after gynecologic surgical procedures

0 - 10 NRS scale of the overall pain in the first 48 hrs after gynecologic surgical procedures

Time frame: 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 from the administration of reversal agent to a TOF≥0.9

Time frame: The recovery time (or Reversal time) will be measured in minutes after the administration of reversal agent at the end of the surgical procedure