The Effects of Dexmedetomidine on Peroperative Shivering Incidence Under Spinal Anesthesia

Perioperative/Postoperative Complications Clinical Trial

Official title:

The Effects of Dexmedetomidine on Peroperative Shivering Incidence Under Spinal Anesthesia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01921361
• Other study ID #: B.30.2.ERC.0.01.00.01/27
• Status: Completed
• Phase: Phase 4
• First received: August 3, 2013
• Last updated: August 12, 2013
• Start date: January 2011
• Est. completion date: January 2012

Study information

• Verified date: August 2013
• Source: TC Erciyes University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Perioperative/Postoperative Complications
• Postoperative Complications

Intervention

Drug:
• Levobupivacaine
Intrathecal 3ml (15 mg)
• Dexmedetomidine
Intrathecal 3 microgram (diluted 1/10, 0.3 ml)
• Dexmedetomidine
Intravenous 1ml/kg/10 minutes and than 0.5 ml/kg/hour infusion (dexmedetomidine diluted 1 microgram/ml)
• 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.

Locations

Country	Name	City	State
Turkey	Erciyes University	Kayseri

Sponsors (1)

Lead Sponsor	Collaborator
TC Erciyes University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	shivering score		1 day (From start of anaesthesia till discharge from the recovery room )	No
Secondary	blood pressure	non invasive blood pressure measured	1 day (From start of anaesthesia till discharge from the recovery room )	No
Secondary	heart rate		1 day (From start of anaesthesia till discharge from the recovery room )	No
Secondary	core temperature	lower than 36 celsius degree was accepted as hypothermia	1 day (From start of anaesthesia till discharge from the recovery room )	No