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Trial record 4 of 1708 for:    CARBON DIOXIDE AND 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

Tracking Information
First Submitted Date  ICMJE December 14, 2014
First Posted Date  ICMJE December 18, 2014
Last Update Posted Date December 18, 2014
Study Start Date  ICMJE December 2014
Estimated Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 14, 2014)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: December 14, 2014)
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Standard Carbon Dioxide Gas Versus Heated Humidified Gas in Gynaecological Laparoscopy
Official Title  ICMJE 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.
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Heated Humidified Carbon Dioxide in Gynaecological Laparoscopic Surgery
Intervention  ICMJE
  • Device: Standard cold carbon dioxide gas
    Use of standard cold carbon dioxide gas in laparoscopic gynaecological surgery.
  • Device: Heated humidified carbon dioxide gas
    Use of the Fischer and Paykel heated humidification system for laparoscopic gynaecological surgery.
Study Arms  ICMJE
  • Placebo Comparator: Standard cold carbon dioxide gas
    Standard cold carbon dioxide gas
    Intervention: Device: Standard cold carbon dioxide gas
  • Active Comparator: Heated humidified carbon dioxide gas
    Heated humidified carbon dioxide gas
    Intervention: Device: Heated humidified carbon dioxide gas
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: December 14, 2014)
88
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2015
Estimated Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02319902
Other Study ID Numbers  ICMJE 14SURN0015
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Fevzi Shakir, Royal Surrey County Hospital NHS Foundation Trust
Study Sponsor  ICMJE Fevzi Shakir
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Royal Surrey County Hospital NHS Foundation Trust
Verification Date December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP