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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.
Register: ClinicalTrials.gov
Last refreshed on: 19 February 2015
Main ID:  NCT01921361
Date of registration: 03/08/2013
Prospective Registration: No
Primary sponsor: TC Erciyes University
Public title: The Effects of Dexmedetomidine on Peroperative Shivering Incidence Under Spinal Anesthesia
Scientific title: The Effects of Dexmedetomidine on Peroperative Shivering Incidence Under Spinal Anesthesia
Date of first enrolment: January 2011
Target sample size: 120
Recruitment status: Completed
URL:  http://clinicaltrials.gov/show/NCT01921361
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention  
Phase:  Phase 4
Countries of recruitment
Turkey
Contacts
Name:     Resul Altuntas, MD
Address: 
Telephone:
Email:
Affiliation:  Erciyes University
Key inclusion & exclusion criteria

Inclusion Criteria:

- 18-65 y/o patients

- American Society of Anesthesiologists' physical status class I-II

- Scheduled for the spinal anesthesia

Exclusion Criteria:

- Patients who have the body temperature over 37.3 celsius degree

- Pregnants

- Known allergies to the study drugs

- Contraindication to spinal anesthesia



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both
Health Condition(s) or Problem(s) studied
Perioperative/Postoperative Complications
Intervention(s)
Drug: sodium chloride
Drug: Levobupivacaine
Drug: Dexmedetomidine
Primary Outcome(s)
shivering score [Time Frame: 1 day (From start of anaesthesia till discharge from the recovery room )]
Secondary Outcome(s)
core temperature [Time Frame: 1 day (From start of anaesthesia till discharge from the recovery room )]
blood pressure [Time Frame: 1 day (From start of anaesthesia till discharge from the recovery room )]
heart rate [Time Frame: 1 day (From start of anaesthesia till discharge from the recovery room )]
Secondary ID(s)
B.30.2.ERC.0.01.00.01/27
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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