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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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16 December 2017 |
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Main ID: |
NCT03107832 |
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Date of registration:
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29/03/2017 |
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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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Thoracic Epidural Versus General Anaesthesia in Cholecystectomy
EVGAC |
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Scientific title:
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Comparison of Bi-spectral Index-Controlled Sedation During a Thoracic Epidural Anesthesia With General Anesthesia in Laparoscopic Cholecystectomy |
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Date of first enrolment:
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December 30, 2012 |
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Target sample size:
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40 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03107832 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Turkey
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Key inclusion & exclusion criteria
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- Inclusion Criteria:
- American Society of Anesthesiologists I-II classification ,
- Elective laparoscopic cholecystectomy ,
- Ages of 18 and 75
- Exclusion Criteria:
- allergies against any of the drugs to be used in the study,
- current pregnancy,
- severe cardiac, renal, and liver diseases,
- previous upper abdominal surgery,
- acute cholangitis,
- a body mass index >32 kg m2,
- contraindications for epidural anesthesia and elective surgery
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Surgical Procedure, Unspecified
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Intervention(s)
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Procedure: thoracic epidural anesthesia procedure
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Primary Outcome(s)
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patient satisfaction
[Time Frame: after postoperative 24 hour]
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Secondary Outcome(s)
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heart rate
[Time Frame: intaoperative 0, 5, 10, 15, 30, and 45 minutes]
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Sore throat
[Time Frame: postoperative 24 hour]
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Nausea / vomiting
[Time Frame: postoperative 24 hour]
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mean arterial pressure
[Time Frame: intaoperative 0, 5, 10, 15, 30, and 45 minutes]
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Hypotension
[Time Frame: During the operation]
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Bradycardia
[Time Frame: During the operation]
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Blood gas analysis
[Time Frame: intaoperative 0 and 35 minutes]
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Shoulder pain
[Time Frame: intraoperative and postoperative 24 hour]
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Secondary ID(s)
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AbantIBU mb2
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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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