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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT00792389
Other study ID # PAT-HWA-001
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received November 14, 2008
Last updated November 14, 2008
Start date January 2009
Est. completion date January 2010

Study information

Verified date November 2008
Source Pennine Acute Hospitals NHS Trust
Contact Stephanie L Trevelyan, MBChB
Phone 01616200420
Email stephanie.trevelyan@pat.nhs.uk
Is FDA regulated No
Health authority UK:National Health ServiceUK:Research Ethics Committee
Study type Interventional

Clinical Trial Summary

Double blind RCT comparing elective laparoscopic cholecystectomy using warmed, humidified gas (new) against laparoscopic cholecystectomy with cool, dry gas (usual). Sample size of 200 patients. Outcome measures are postoperative opiate analgesia use, and post operative numerical pain scores.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 200
Est. completion date January 2010
Est. primary completion date January 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- elective laparoscopic cholecystectomy

- 18 years of age or over

Exclusion Criteria:

- under 18 years of age

- prisoners

- converted to open operation

- secondary invasive procedure during operation

- unable to give consent for whatever reason

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Intervention

Other:
Warm humidified C02
Insufflation of warmed humidified gas during laparoscopic cholecystectomy
Cool dry C02
Insufflation of cool dry gas during laparoscopic cholecystectomy

Locations

Country Name City State
United Kingdom Royal Oldham Hospital Oldham Lancashire

Sponsors (1)

Lead Sponsor Collaborator
Pennine Acute Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Total post operative opiate analgesia - morphine equivalent dose. 1 day No
Secondary Subjective post operative pain as defined on numerical pain scales 1 day No
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