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Role of Curarization During Anesthesia for Gynecologic Surgical Laparotomy Procedures

NCT03519724 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2018-07-10

No results posted yet for this study

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

Conditions

  • Curarization, Postoperative Residual

Interventions

DRUG

Sugammadex

Reversal of deep NMB

DRUG

Neostigmine

Reversal of moderate NMB

Sponsors & Collaborators

  • Campus Bio-Medico University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-30
Primary Completion
2018-09-30
Completion
2019-01-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03519724 on ClinicalTrials.gov