Respiratory Mechanics and Metabolic Changes During Low Pressure Laparoscopic Cholecystectomy

March 25, 2017 updated by: khaled salah mohamed, Assiut University

The Impact of Deep Versus Moderate Neuromuscular Block on Respiratory System Mechanics and Metabolic Changes During Laparoscopic Cholecystectomy a Double-Blind Randomized Clinical Trial.

The investigators aim to investigate the differences between deep continuous muscle relaxation and moderate blockade during low-pressure (8 mmHg) laparoscopic cholecystectomy in respect to metabolic changes and respiratory mechanics.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

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

  • Egypt
    • اسيوط
      • Assuit, اسيوط, Egypt, 71515
        • Al Rajhy liver hospital

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 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • more than 18 years
  • undergoing elective laparoscopic cholecystectomy

Exclusion Criteria:

  • previous surgeries,
  • a history of venous or arterial diseases,
  • BMI (≥30 kg/m2),
  • Allergy to rocuronium.
  • Significant liver dysfunction.
  • Significant renal dysfunction (S-creatinine > 200 umol/l).
  • Neuromuscular disease that might impair neuromuscular blockade
  • Pregnant or breastfeeding.
  • Indication for rapid sequence induction.
  • Inability to informed consent

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: group D
deep neuromuscular block by rocuronium defined :post tetanic (PTC) >1 but no response to a train of four (TOF) stimulation.
Drug: Rocuronium
Active Comparator: group I
intermediate neuromuscular block by rocuronium defined as TOF count of 1-3.
Drug: Rocuronium

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
respiratory mechanics (Dynamic compliance)
Time Frame: intraoperative
Dynamic compliance
intraoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
surgeon satisfaction (scale from 1 to 5)
Time Frame: intraoperative
scale from 1 to 5
intraoperative
postoperative pain (VAS score)
Time Frame: postoperative for 6 hours
VAS score
postoperative for 6 hours
postoperative nausea and vomiting
Time Frame: postoperative for 6 hours
postoperative for 6 hours
completion of surgical procedure
Time Frame: intraoperative
yes or no
intraoperative
metabolic changes (blood lactate)
Time Frame: intraoperative
blood lactate
intraoperative

Collaborators and Investigators

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

Sponsor

Assiut University

Investigators

  • Study Chair: Osama ibraheim, MD, Assiut University
  • Study Chair: MOSTAFA ABBAS, MD, Assiut University
  • Study Chair: AHMED TAHA, MD, Assiut 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

October 1, 2014

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

May 24, 2015

First Submitted That Met QC Criteria

June 11, 2015

First Posted (Estimate)

June 12, 2015

Study Record Updates

Last Update Posted (Actual)

March 28, 2017

Last Update Submitted That Met QC Criteria

March 25, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • low pressure lap chole.

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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