Role of Curarization During Anesthesia for Gynecologic Surgical Laparoscopic Procedures

July 9, 2018 updated by: Corrado Terranova, Campus Bio-Medico University

The Role of Curarization During Anesthesia for Gynecologic Surgical Laparoscopic Procedures: a Double Blind Randomized Controlled Trial.

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • RM
      • Roma, RM, Italy, 00128
        • Campus Bio-Medico

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: SUG
Drug: Sugammadex
Reversal of deep NMB
ACTIVE_COMPARATOR: NEO
Drug: Neostigmine
Reversal of moderate NMB

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall pain in the first 48 hrs after gynecologic surgical procedures
Time Frame: First 48 hrs after gynecologic surgical procedures
0-10 NRS
First 48 hrs after gynecologic surgical procedures
Recovery time (or Reversal time) from NMB (TOF≥0.9)
Time Frame: Recovery time (or Reversal time) from NMB (TOF≥0.9) will be measured after the administration of reversal agent at the end of the surgical procedure.
Recovery time (or Reversal time) from NMB (TOF≥0.9), measured in minutes from to administration of reversal agent to a TOF≥0.9
Recovery time (or Reversal time) from NMB (TOF≥0.9) will be measured after the administration of reversal agent at the end of the surgical procedure.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Campus Bio-Medico University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

July 30, 2018

Primary Completion (ANTICIPATED)

September 30, 2018

Study Completion (ANTICIPATED)

January 30, 2019

Study Registration Dates

First Submitted

March 9, 2018

First Submitted That Met QC Criteria

April 26, 2018

First Posted (ACTUAL)

May 9, 2018

Study Record Updates

Last Update Posted (ACTUAL)

July 10, 2018

Last Update Submitted That Met QC Criteria

July 9, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GYN LPS-CUR 2018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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