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The Effects of Dexmedetomidine on Peroperative Shivering Incidence Under Spinal Anesthesia

NCT ID: NCT01921361

Last Updated: 2013-08-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2012-01-31

Brief Summary

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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

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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.

Conditions

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Perioperative/Postoperative Complications

Keywords

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Shivering Dexmedetomidine Spinal anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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)

Group Type ACTIVE_COMPARATOR

Levobupivacaine

Intervention Type DRUG

Intrathecal 3ml (15 mg)

Dexmedetomidine

Intervention Type DRUG

Intrathecal 3 microgram (diluted 1/10, 0.3 ml)

sodium chloride

Intervention Type DRUG

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.

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)

Group Type ACTIVE_COMPARATOR

Levobupivacaine

Intervention Type DRUG

Intrathecal 3ml (15 mg)

Dexmedetomidine

Intervention Type DRUG

Intravenous 1ml/kg/10 minutes and than 0.5 ml/kg/hour infusion (dexmedetomidine diluted 1 microgram/ml)

sodium chloride

Intervention Type DRUG

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.

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).

Group Type PLACEBO_COMPARATOR

Levobupivacaine

Intervention Type DRUG

Intrathecal 3ml (15 mg)

sodium chloride

Intervention Type DRUG

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.

Interventions

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Levobupivacaine

Intrathecal 3ml (15 mg)

Intervention Type DRUG

Dexmedetomidine

Intrathecal 3 microgram (diluted 1/10, 0.3 ml)

Intervention Type DRUG

Dexmedetomidine

Intravenous 1ml/kg/10 minutes and than 0.5 ml/kg/hour infusion (dexmedetomidine diluted 1 microgram/ml)

Intervention Type DRUG

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.

Intervention Type DRUG

Other Intervention Names

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Chirocaine, 0.5%, 10 ml, Abbott Precedex, 100 mcg/ml, Abbott Precedex, 100 mcg/ml, Abbott 0.9 Sodium chloride

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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TC Erciyes University

OTHER

Sponsor Role lead

Responsible Party

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RESUL ALTUNTAS

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Resul Altuntas, MD

Role: PRINCIPAL_INVESTIGATOR

TC Erciyes University

Locations

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Erciyes University

Kayseri, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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B.30.2.ERC.0.01.00.01/27

Identifier Type: -

Identifier Source: org_study_id