The Effects of Dexmedetomidine on Peroperative Shivering Incidence Under Spinal Anesthesia
1 other identifier
interventional
120
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Jan 2011
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2012
CompletedFirst Submitted
Initial submission to the registry
August 3, 2013
CompletedFirst Posted
Study publicly available on registry
August 13, 2013
CompletedAugust 13, 2013
August 1, 2013
1 year
August 3, 2013
August 12, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
shivering score
1 day (From start of anaesthesia till discharge from the recovery room )
Secondary Outcomes (3)
blood pressure
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
1 day (From start of anaesthesia till discharge from the recovery room )
Study Arms (3)
Intravenous
ACTIVE COMPARATORIntrathecal (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)
Intrathecal
ACTIVE COMPARATORIntrathecal (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)
Control
PLACEBO COMPARATORIntrathecal (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
Intrathecal 3ml (15 mg)
Intrathecal 3 microgram (diluted 1/10, 0.3 ml)
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.
Eligibility Criteria
You may qualify if:
- y/o patients
- American Society of Anesthesiologists' physical status class I-II
- Scheduled for the spinal anesthesia
You may not qualify if:
- Patients who have the body temperature over 37.3 celsius degree
- Pregnants
- Known allergies to the study drugs
- Contraindication to spinal anesthesia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Erciyes University
Kayseri, 38039, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Resul Altuntas, MD
TC Erciyes University
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
August 3, 2013
First Posted
August 13, 2013
Study Start
January 1, 2011
Primary Completion
January 1, 2012
Study Completion
January 1, 2012
Last Updated
August 13, 2013
Record last verified: 2013-08