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The Effects of Dexmedetomidine on Peroperative Shivering Incidence Under Spinal Anesthesia

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: NCT01921361
Recruitment Status : Completed
First Posted : August 13, 2013
Last Update Posted : August 13, 2013
Sponsor:
Information provided by (Responsible Party):
RESUL ALTUNTAS, TC Erciyes University

Tracking Information
First Submitted Date  ICMJE August 3, 2013
First Posted Date  ICMJE August 13, 2013
Last Update Posted Date August 13, 2013
Study Start Date  ICMJE January 2011
Actual Primary Completion Date January 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 12, 2013)
shivering score [ Time Frame: 1 day (From start of anaesthesia till discharge from the recovery room ) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: August 12, 2013)
  • blood pressure [ Time Frame: 1 day (From start of anaesthesia till discharge from the recovery room ) ]
    non invasive blood pressure measured
  • heart rate [ Time Frame: 1 day (From start of anaesthesia till discharge from the recovery room ) ]
  • core temperature [ Time Frame: 1 day (From start of anaesthesia till discharge from the recovery room ) ]
    lower than 36 celsius degree was accepted as hypothermia
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 The Effects of Dexmedetomidine on Peroperative Shivering Incidence Under Spinal Anesthesia
Official Title  ICMJE The Effects of Dexmedetomidine on Peroperative Shivering Incidence Under Spinal Anesthesia
Brief Summary The purpose of this study to compare the efficacy of intravenous or intrathecal dexmedetomidine on the incidence of shivering on patients who scheduled spinal anesthesia for elective surgery.
Detailed Description

The design of the study includes three study groups done in random order. The groups are as follows: 1) Control group received 15 mg levobupivacaine intrathecally and intravenous 0.9% sodium chloride; 2) Intravenous group received 15 mg levobupivacaine intrathecally and intravenous dexmedetomidine (1mcg/kg/10min, 0.5mcg/kg/h infusion) ; 3) Intrathecal group received 15 mg levobupivacaine + 3 mcg dexmedetomidine intrathecally and intravenous 0.9% sodium chloride.

Throughout the study period,shivering scores, tympanic temperature were recorded, heart rate were measured continuously using an electrocardiogram; blood pressure was determined oscillometrically at 5 min intervals at the ankle. In case heart rate decreased by more than 30% of the baseline atropin received and blood pressure decreased 30% of the baseline effedrin received.

Side effects (bradycardia, hypotension, hypothermia, nausea and vomiting etc ) were recorded peroperatively in the operating room and postanesthetic care unit.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Perioperative/Postoperative Complications
Intervention  ICMJE
  • Drug: Levobupivacaine
    Intrathecal 3ml (15 mg)
    Other Name: Chirocaine, 0.5%, 10 ml, Abbott
  • Drug: Dexmedetomidine
    Intrathecal 3 microgram (diluted 1/10, 0.3 ml)
    Other Name: Precedex, 100 mcg/ml, Abbott
  • Drug: Dexmedetomidine
    Intravenous 1ml/kg/10 minutes and than 0.5 ml/kg/hour infusion (dexmedetomidine diluted 1 microgram/ml)
    Other Name: Precedex, 100 mcg/ml, Abbott
  • Drug: sodium chloride
    Intravenous 1ml/kg/10 minutes and than 0.5 ml/kg/hour infusion in the control and intrathecal groups, intrathecal 0.3 ml in the control and intravenous groups.
    Other Name: 0.9 Sodium chloride
Study Arms  ICMJE
  • Active Comparator: Intravenous
    Intrathecal (3 ml) 15 mg levobupivacaine + 0.3 ml 0.9% Sodium chloride and intravenous dexmedetomidine (dexmedetomidine diluted 1mcg/ml and than 1ml/kg/10 minutes and 0.5 ml/kg/hour infusion)
    Interventions:
    • Drug: Levobupivacaine
    • Drug: Dexmedetomidine
    • Drug: sodium chloride
  • Active Comparator: Intrathecal
    Intrathecal (3 ml) 15 mg levobupivacaine + (0.3 ml) 3 mcg dexmedetomidine (dexmedetomidine diluted 10 mcg/ml) and intravenous 0.9% Sodium chloride (1ml/kg/10 minutes and 0.5 ml/kg/hour infusion)
    Interventions:
    • Drug: Levobupivacaine
    • Drug: Dexmedetomidine
    • Drug: sodium chloride
  • Placebo Comparator: Control
    Intrathecal (3 ml) 15 mg levobupivacaine + 0.3 ml 0.9% Sodium chloride and intravenous 0.9% Sodium chloride (1ml/kg/10 minutes and 0.5 ml/kg/hour infusion).
    Interventions:
    • Drug: Levobupivacaine
    • Drug: sodium chloride
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 Completed
Actual Enrollment  ICMJE
 (submitted: August 12, 2013)
120
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2012
Actual Primary Completion Date January 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Turkey
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01921361
Other Study ID Numbers  ICMJE B.30.2.ERC.0.01.00.01/27
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party RESUL ALTUNTAS, TC Erciyes University
Study Sponsor  ICMJE TC Erciyes University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Resul Altuntas, MD TC Erciyes University
PRS Account TC Erciyes University
Verification Date August 2013

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