The Effects of Dexmedetomidine on Peroperative Shivering Incidence Under Spinal Anesthesia

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.

Study Overview

• Status: Completed
• Conditions: Perioperative/Postoperative Complications
• Intervention / Treatment: Drug: Levobupivacaine; Drug: Dexmedetomidine; Drug: Dexmedetomidine; Drug: sodium chloride

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: Interventional
• Enrollment (Actual): 120
• Phase: Phase 4

Contacts and Locations

Study Locations

• Turkey
  • Kayseri, Turkey, 38039
    • Erciyes University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / 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 Names: Chirocaine, 0.5%, 10 ml, Abbott; Drug: Dexmedetomidine; Intrathecal 3 microgram (diluted 1/10, 0.3 ml); Other Names: 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 Names: 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 Names: 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 Names: Chirocaine, 0.5%, 10 ml, Abbott; Drug: Dexmedetomidine; Intrathecal 3 microgram (diluted 1/10, 0.3 ml); Other Names: 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 Names: 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 Names: 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 Names: 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 Names: 0.9 Sodium chloride

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
shivering score	1 day (From start of anaesthesia till discharge from the recovery room )

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
blood pressure	non invasive blood pressure measured	1 day (From start of anaesthesia till discharge from the recovery room )
heart rate		1 day (From start of anaesthesia till discharge from the recovery room )
core temperature	lower than 36 celsius degree was accepted as hypothermia	1 day (From start of anaesthesia till discharge from the recovery room )

Collaborators and Investigators

• Sponsor: TC Erciyes University
• Investigators: Principal Investigator: Resul Altuntas, MD, TC Erciyes University

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): January 1, 2012
• Study Completion (Actual): January 1, 2012

Study Registration Dates

• First Submitted: August 3, 2013
• First Submitted That Met QC Criteria: August 12, 2013
• First Posted (Estimate): August 13, 2013

Study Record Updates

• Last Update Posted (Estimate): August 13, 2013
• Last Update Submitted That Met QC Criteria: August 12, 2013
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Keywords: Spinal anesthesia; Dexmedetomidine; Shivering
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Anesthetics, Local; Dexmedetomidine; Levobupivacaine
• Other Study ID Numbers: B.30.2.ERC.0.01.00.01/27