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The Effects of Dexmedetomidine on Peroperative Shivering Incidence Under Spinal Anesthesia

Primary Purpose

Perioperative/Postoperative Complications

Status

Completed

Phase

Phase 4

Locations

Turkey

Study Type

Interventional

Intervention

Levobupivacaine

Dexmedetomidine

sodium chloride

About this trial

This is an interventional prevention trial for Perioperative/Postoperative Complications focused on measuring Shivering, Dexmedetomidine, Spinal anesthesia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Erciyes University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Intravenous

Intrathecal

Control

Arm Description

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 (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)

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).

Outcomes

Primary Outcome Measures

shivering score

Secondary Outcome Measures

blood pressure

non invasive blood pressure measured

heart rate

core temperature

lower than 36 celsius degree was accepted as hypothermia

Full Information

NCT ID

NCT01921361

First Posted

August 3, 2013

Last Updated

August 12, 2013

Sponsor

TC Erciyes University

1. Study Identification

Unique Protocol Identification Number

NCT01921361

Brief Title

The Effects of Dexmedetomidine on Peroperative Shivering Incidence Under Spinal Anesthesia

Official Title

The Effects of Dexmedetomidine on Peroperative Shivering Incidence Under Spinal Anesthesia

Study Type

Interventional

2. Study Status

Record Verification Date

August 2013

Overall Recruitment Status

Completed

Study Start Date

January 2011 (undefined)

Primary Completion Date

January 2012 (Actual)

Study Completion Date

January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

TC Erciyes University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Perioperative/Postoperative Complications

Keywords

Shivering, Dexmedetomidine, Spinal anesthesia

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

120 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intravenous

Arm Type

Active Comparator

Arm Description

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)

Arm Title

Intrathecal

Arm Type

Active Comparator

Arm Description

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)

Arm Title

Control

Arm Type

Placebo Comparator

Arm Description

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 Type

Drug

Intervention Name(s)

Levobupivacaine

Other Intervention Name(s)

Chirocaine, 0.5%, 10 ml, Abbott

Intervention Description

Intrathecal 3ml (15 mg)

Intervention Type

Drug

Intervention Name(s)

Dexmedetomidine

Other Intervention Name(s)

Precedex, 100 mcg/ml, Abbott

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Dexmedetomidine

Other Intervention Name(s)

Precedex, 100 mcg/ml, Abbott

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

sodium chloride

Other Intervention Name(s)

0.9 Sodium chloride

Intervention Description

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.

Primary Outcome Measure Information:

Title

shivering score

Time Frame

1 day (From start of anaesthesia till discharge from the recovery room )

Secondary Outcome Measure Information:

Title

blood pressure

Description

non invasive blood pressure measured

Time Frame

1 day (From start of anaesthesia till discharge from the recovery room )

Title

heart rate

Time Frame

1 day (From start of anaesthesia till discharge from the recovery room )

Title

core temperature

Description

lower than 36 celsius degree was accepted as hypothermia

Time Frame

1 day (From start of anaesthesia till discharge from the recovery room )

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Resul Altuntas, MD

Organizational Affiliation

TC Erciyes University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Erciyes University

City

Kayseri

ZIP/Postal Code

38039

Country

Turkey

12. IPD Sharing Statement

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The Effects of Dexmedetomidine on Peroperative Shivering Incidence Under Spinal Anesthesia

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