Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 5 of 2495 for:    CARBON DIOXIDE

Standard Carbon Dioxide Gas Versus Heated Humidified Gas in Gynaecological Laparoscopy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02319902
Recruitment Status : Unknown
Verified December 2014 by Fevzi Shakir, Royal Surrey County Hospital NHS Foundation Trust.
Recruitment status was:  Recruiting
First Posted : December 18, 2014
Last Update Posted : December 18, 2014
Sponsor:
Information provided by (Responsible Party):
Fevzi Shakir, Royal Surrey County Hospital NHS Foundation Trust

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Heated Humidified Carbon Dioxide in Gynaecological Laparoscopic Surgery Device: Standard cold carbon dioxide gas Device: Heated humidified carbon dioxide gas Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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.
Study Start Date : December 2014
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Standard cold carbon dioxide gas
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
Heated humidified carbon dioxide gas
Device: Heated humidified carbon dioxide gas
Use of the Fischer and Paykel heated humidification system for laparoscopic gynaecological surgery.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02319902


Contacts
Layout table for location contacts
Contact: Fevzi Shakir, MBBS BSc MRCOG fevzi@doctors.org.uk
Contact: Andrew Kent, TD MD FRCOG kenta@doctors.org.uk

Locations
Layout table for location information
United Kingdom
Royal Surrey County Hospital NHS Trust Recruiting
Guildford, Surrey, United Kingdom, GU2 7XX
Contact: Fevzi Shakir, MBBS BSc MRCOG       fevzi@doctors.org.uk   
Contact: Andrew Kent, TD MD FRCOG       kenta@doctors.org.uk   
Sponsors and Collaborators
Fevzi Shakir

Layout table for additonal information
Responsible Party: Fevzi Shakir, Senior Clinical Research Fellow in Advanced Gynaecological Laparoscopic Surgery, Royal Surrey County Hospital NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT02319902     History of Changes
Other Study ID Numbers: 14SURN0015
First Posted: December 18, 2014    Key Record Dates
Last Update Posted: December 18, 2014
Last Verified: December 2014