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The Effects of Dexmedetomidine on Peroperative Shivering Incidence Under Spinal Anesthesia

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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

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.

Condition or disease Intervention/treatment Phase
Perioperative/Postoperative Complications Drug: Levobupivacaine Drug: Dexmedetomidine Drug: sodium chloride Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Effects of Dexmedetomidine on Peroperative Shivering Incidence Under Spinal Anesthesia
Study Start Date : January 2011
Actual Primary Completion Date : January 2012
Actual Study Completion Date : January 2012

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Arm Intervention/treatment
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)
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: 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

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)
Drug: Levobupivacaine
Intrathecal 3ml (15 mg)
Other Name: Chirocaine, 0.5%, 10 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

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).
Drug: Levobupivacaine
Intrathecal 3ml (15 mg)
Other Name: Chirocaine, 0.5%, 10 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




Primary Outcome Measures :
  1. shivering score [ Time Frame: 1 day (From start of anaesthesia till discharge from the recovery room ) ]

Secondary Outcome Measures :
  1. blood pressure [ Time Frame: 1 day (From start of anaesthesia till discharge from the recovery room ) ]
    non invasive blood pressure measured

  2. heart rate [ Time Frame: 1 day (From start of anaesthesia till discharge from the recovery room ) ]
  3. 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



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01921361


Locations
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Turkey
Erciyes University
Kayseri, Turkey, 38039
Sponsors and Collaborators
TC Erciyes University
Investigators
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Principal Investigator: Resul Altuntas, MD TC Erciyes University

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Responsible Party: RESUL ALTUNTAS, MD, TC Erciyes University
ClinicalTrials.gov Identifier: NCT01921361     History of Changes
Other Study ID Numbers: B.30.2.ERC.0.01.00.01/27
First Posted: August 13, 2013    Key Record Dates
Last Update Posted: August 13, 2013
Last Verified: August 2013

Keywords provided by RESUL ALTUNTAS, TC Erciyes University:
Shivering
Dexmedetomidine
Spinal anesthesia

Additional relevant MeSH terms:
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Postoperative Complications
Pathologic Processes
Anesthetics
Levobupivacaine
Dexmedetomidine
Central Nervous System Depressants
Physiological Effects of Drugs
Hypnotics and Sedatives
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anesthetics, Local