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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT01182545 |
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Date of registration:
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12/08/2010 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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The Effects of Hyperventilation Prior to CO2 Insufflation During Laparoscopic Cholecystectomy
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Scientific title:
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A Prospective Randomized Study of the Effects of Hyperventilation Prior to Carbon Dioxide Insufflation on Hemodynamic Changes During Laparoscopic Cholecystectomy |
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Date of first enrolment:
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December 2008 |
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Target sample size:
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100 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01182545 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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Phase:
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Phase 1
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Countries of recruitment
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Saudi Arabia
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Contacts
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Name:
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Mohamed R El Tahan, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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King Faisal University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- ASA I & II
- aged 18-45 years
- undergoing elective laparoscopic cholecystectomy
Exclusion Criteria:
- history of cardiovascular disease
- respiratory diseases
- neurological disease
- renal disease
- liver disease
- hormonal disease
- pregnancy
- obesity (defined as a body mass index> 29)
- smokers
Age minimum:
18 Years
Age maximum:
45 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Laparoscopic Cholecystectomy
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Intervention(s)
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Procedure: Ventilation
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Primary Outcome(s)
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haemodynamic percussion response
[Time Frame: at 5 and 10 minutes, in supine and Trendelenburg (30° head-down) positions, respectively, before CO2 insufflation and at 15, 30, 45, and 60 min after CO2 insufflation, and at 5 min after desufflation of pneumoperitoneum]
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Secondary Outcome(s)
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other hemodynamic and respiratory parameters
[Time Frame: at 5 and 10 minutes, in supine and Trendelenburg (30° head-down) positions, respectively, before CO2 insufflation and at 15, 30, 45, and 60 min after CO2 insufflation, and at 5 min after desufflation of pneumoperitoneum,]
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Secondary ID(s)
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23-10-2007
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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