Skip to main content
OpenTrials
Completed

NCT Number: NCT01921361

The Effects of Dexmedetomidine on Peroperative Shivering Incidence Under Spinal Anesthesia

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Perioperative/Postoperative Complications Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Erciyes University

Kayseri, 38039, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Levobupivacaine

Drug

Intrathecal 3ml (15 mg)

Other names: Chirocaine, 0.5%, 10 ml, Abbott

Dexmedetomidine

Drug

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

Other names: Precedex, 100 mcg/ml, Abbott

Sodium Chloride

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.

Other names: 0.9 Sodium chloride

Primary outcomes

  1. shivering score

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

Secondary outcomes

  1. blood pressure

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

    non invasive blood pressure measured

  2. heart rate

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

  3. core temperature

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

    lower than 36 celsius degree was accepted as hypothermia

Sponsors and collaborators

Lead sponsor

TC Erciyes University

Other

Registry information

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Aug 13, 2013
Registry last updated
Aug 13, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.