Comparing Nitrous Oxide and Carbon Dioxide for Laparoscopic Cholecystectomy

January 15, 2012 updated by: Mehdi Asgari, Ahvaz Jundishapur University of Medical Sciences

Prospective Randomized Trial Comparing Nitrous Oxide and Carbon Dioxide for Laparoscopic Cholecystectomy

There is no general agreement about the ideal gas for pneumoperitoneum. CO2, now in common use, has not compared to N2O sufficiently to disclose which one has minimal "physiological" invasiveness characters. Assigned randomly to carbon dioxide or nitrous oxide group, the hemodynamic and respiratory parameters (heart rate, mean arterial blood pressure, end-tidal CO2, minute ventilation, and O2 saturation) before pneumoperitoneum and during it were recorded. Pain, as perceived by patients, is measured 2, 4 and 24 hours after the procedure by visual analogue scale. Vomiting and use of analgesics and antiemetics were recorded and compared.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

64

Phase

  • Not Applicable

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

  • Iran, Islamic Republic of
    • Khuzestan
      • Ahvaz, Khuzestan, Iran, Islamic Republic of
        • Ahvaz jundishapur university of medical sciences; Razi 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

No older than 63 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • developed gallstones
  • candidates for laparoscopic cholecystectomy
  • written informed consent
  • ASA Score = 1&2

Exclusion Criteria:

  • signs and complications of gallstones in admission include acute cholecystitis and suppurative cholangitis
  • complete Inability to move
  • severe physical or mental disorders leading to inability to communicate -Pregnancy and
  • cancer

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

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: nitrous oxide
use nitrous oxide for pneumoperitoneum creation
Procedure: nitrous oxide use for pneumoperitoneum creation
use nitrous oxide for create pneumoperitoneum in laparoscopic cholecystectomy
Placebo Comparator: carbon dioxide
use carbon dioxide for pneumoperitoneum creation
Procedure: nitrous oxide use for pneumoperitoneum creation
use nitrous oxide for create pneumoperitoneum in laparoscopic cholecystectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
heart rate
Time Frame: At the start of laparoscopic surgery and Immediately after surgery.
number of heartbeats per minute measured in At the start of laparoscopic surgery and Immediately after surgery.
At the start of laparoscopic surgery and Immediately after surgery.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean arterial pressure
Time Frame: At the start of laparoscopic surgery and Immediately after surgery.
average arterial pressure during a single cardiac cycle At the start of laparoscopic surgery and Immediately after surgery
At the start of laparoscopic surgery and Immediately after surgery.

Collaborators and Investigators

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

Sponsor

Ahvaz Jundishapur University of Medical Sciences

Investigators

  • Principal Investigator: Mehdi Asgari, PhD, Ahvaz Jundishapur University of Medical Sciences

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

November 1, 2010

Primary Completion (Actual)

March 1, 2011

Study Completion (Actual)

April 1, 2011

Study Registration Dates

First Submitted

January 3, 2012

First Submitted That Met QC Criteria

January 15, 2012

First Posted (Estimate)

January 19, 2012

Study Record Updates

Last Update Posted (Estimate)

January 19, 2012

Last Update Submitted That Met QC Criteria

January 15, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • u-89140

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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