Perioperative/Postoperative Complications
Conditions
Keywords
Shivering, Dexmedetomidine, 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.
Interventions
DRUGLevobupivacaine
Intrathecal 3ml (15 mg)
DRUGDexmedetomidine
Intrathecal 3 microgram (diluted 1/10, 0.3 ml)
DRUGsodium 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.
Sponsors
TC Erciyes University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| shivering score | 1 day (From start of anaesthesia till discharge from the recovery room ) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| blood pressure | 1 day (From start of anaesthesia till discharge from the recovery room ) | non invasive blood pressure measured |
| 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 ) | lower than 36 celsius degree was accepted as hypothermia |
Countries
Turkey (Türkiye)
Outcome results
None listed