The Effects of Dexmedetomidine on Peroperative Shivering Incidence Under Spinal Anesthesia
Overview
- Phase
- Phase 4
- Intervention
- Levobupivacaine
- Conditions
- Perioperative/Postoperative Complications
- Sponsor
- TC Erciyes University
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- shivering score
- Status
- Completed
- Last Updated
- 12 years ago
Overview
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.
Investigators
RESUL ALTUNTAS
MD
TC Erciyes University
Eligibility 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
Arms & Interventions
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)
Intervention: Levobupivacaine
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)
Intervention: Dexmedetomidine
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)
Intervention: sodium chloride
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)
Intervention: Levobupivacaine
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)
Intervention: Dexmedetomidine
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)
Intervention: sodium chloride
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).
Intervention: Levobupivacaine
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).
Intervention: sodium chloride
Outcomes
Primary Outcomes
shivering score
Time Frame: 1 day (From start of anaesthesia till discharge from the recovery room )
Secondary Outcomes
- core temperature(1 day (From start of anaesthesia till discharge from the recovery room ))
- 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 ))