Role of Curarization During Anesthesia for Laparoscopic Hysterectomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

238 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-01

Study Completion Date

2024-12-31

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 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.

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Detailed Description

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Conditions

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Curarization, Postoperative Residual Postoperative Pain Of Laparoscopic Surgery PONV

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Anesthesiologists were aware of the treatment assignment, while the surgeon and surgical staff were blinded. Additionally, patients, nurses/doctors assessing outcomes, and the statistician were blinded

Study Groups

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SUG

Group Type EXPERIMENTAL

Sugammadex

Intervention Type DRUG

Reversal of deep NMB

NEO

Group Type ACTIVE_COMPARATOR

Neostigmine

Intervention Type DRUG

Reversal of moderate NMB

Interventions

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Sugammadex

Reversal of deep NMB

Intervention Type DRUG

Neostigmine

Reversal of moderate NMB

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No