The Effects of Dexmedetomidine on Peroperative Shivering Incidence Under Spinal Anesthesia

Phase 4

Completed

• Conditions: Perioperative/Postoperative Complications
• Interventions: Drug: Levobupivacaine; Drug: Dexmedetomidine; Drug: sodium chloride

• Registration Number: NCT01921361
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2011-01
• Primary Completion: 2012-01
• Study Completion: 2012-01
• Status Verified: 2013-08
• Study First Submitted: 2013-08-03
• Study First Submitted QC: 2013-08-12
• Last Update Submitted: 2013-08-12
• Study First Posted: 2013-08-13
• Last Update Posted: 2013-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intravenous	Levobupivacaine	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)
Intravenous	Dexmedetomidine	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)
Intrathecal	Levobupivacaine	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)
Control	sodium chloride	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).
Intravenous	sodium chloride	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)
Intrathecal	Dexmedetomidine	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)
Control	Levobupivacaine	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).
Intrathecal	sodium chloride	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)

Primary Outcome Measures

Name	Time	Method
shivering score	1 day (From start of anaesthesia till discharge from the recovery room )

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Erciyes University; 🇹🇷 Kayseri, Turkey