Standard Carbon Dioxide Gas Versus Heated Humidified Gas in Gynaecological Laparoscopy

December 14, 2014 updated by: Fevzi Shakir

The Effects of Using Heated Humidified Carbon Dioxide Gas on Post Operative Pain Scores, Nausea and Analgesic Requirements in Patients Undergoing Gynaecological Laparoscopy: a Randomised Controlled Trial.

To establish if heated humidified carbon dioxide gas improves pain scores as well as nausea and analgesic requirements in post operative patients compared to standard cold carbon dioxide.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

88

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

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 and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Patients over 18 years of age
  • Patients planned to undergo laparoscopy for minor procedures such as endometriosis, adhesions, ovarian cystectomies, bilateral salpingoophorectomy, tubal ligation and sterilisation will be invited to participate in the trial.
  • Capacity to consent

Exclusion Criteria:

  • Patients unable to speak English
  • Patients unable to give 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
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Standard cold carbon dioxide gas
Device: Standard cold carbon dioxide gas
Use of standard cold carbon dioxide gas in laparoscopic gynaecological surgery.
ACTIVE_COMPARATOR: Heated humidified carbon dioxide gas
Device: Heated humidified carbon dioxide gas
Use of the Fischer and Paykel heated humidification system for laparoscopic gynaecological surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Shoulder tip pain
Time Frame: 8 hours
Shoulder tip pain recorded as a visual analogue scale from 1-10, 8 hours post surgery compared to baseline
8 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
General abdominal pain, nausea, vomiting and analgesia requirements
Time Frame: 8 hours
General abdominal pain, nausea, vomiting and analgesia requirements 8 hours post surgery compared to baseline
8 hours
Shoulder tip pain, general abdominal pain, nausea, vomiting.
Time Frame: 7 days
Shoulder tip pain, general abdominal pain, nausea, vomiting over a 7 day period compared to baseline
7 days

Collaborators and Investigators

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

Sponsor

Fevzi Shakir

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

December 1, 2014

Primary Completion (ANTICIPATED)

December 1, 2015

Study Completion (ANTICIPATED)

December 1, 2015

Study Registration Dates

First Submitted

December 14, 2014

First Submitted That Met QC Criteria

December 14, 2014

First Posted (ESTIMATE)

December 18, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

December 18, 2014

Last Update Submitted That Met QC Criteria

December 14, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

  • 14SURN0015

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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