Role of Curarization During Anesthesia for Gynecologic Surgical Laparotomy Procedures

Study Overview
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Brief Summary
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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

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

Conditions
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Curarization, Postoperative Residual

Intervention / Treatment
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* Drug: Sugammadex
* Drug: Neostigmine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SUG<br> | Drug: Sugammadex<br>* Reversal of deep NMB<br>|
| Active Comparator: NEO<br> | Drug: Neostigmine<br>* Reversal of moderate NMB<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | The recovery time (or Reversal time) will be measured in minutes after the administration of reversal agent at the end of the surgical procedure |