Dexmedetomidine in Post Spinal Anesthesia Shivering

March 3, 2015 updated by: Hala Saad Abdel-Ghaffar, Assiut University

Safety and Efficacy of Dexmedetomidine in Treating Post Spinal Anesthesia Shivering: A Clinically Controlled Dose-finding Study.

This study evaluated the effect of dexmedetomidine iv in three different doses in the treatment of shivering in patients undergoing minor elective abdominal surgery under spinal anesthesia, in comparison with intravenous pethidine.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Among the pharmacological agents used in treatment of shivering, pethidine (meperidine) has been shown to be one of the most effective treatments.The α-2 receptor agonists are another important class of anti-shivering drugs that, unlike meperidine, produce little respiratory depression.

Dexmedetomidine is a highly selective α-2 adrenoceptor agonist with potent effects on the central nervous system . Intravenous dexmedetomidine reduces both the vasoconstriction and shivering thresholds . Clinical studies had demonstrated the efficacy of dexmedetomidine in prevention of shivering . Few clinical trials investigated its efficacy in treatment of established shivering. The optimum dose for shivering control with the least hemodynamic derangements is still under research.

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Assiut governorate
      • Assiut, Assiut governorate, Egypt, 715715
        • Assiut university hospital, Assiut, Egypt

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • American Society of Anesthesiologist class I or II scheduled for elective minor lower abdominal operations under spinal anesthesia for an anticipated duration of >60 and <180 min. (e.g. inguinal herniorRaphy, umbilical hernia repair) who developed shivering during the intra or postoperative period

Exclusion Criteria:

  • Patients with BMI>30 kg /m2
  • Initial body temperature >38 C or <36 C and those with a history of convulsions
  • Multiple allergies
  • Thyroid disease
  • Parkinson's disease
  • Dysautonomia
  • Raynaud's syndrome
  • Hypertension
  • Coronary artery disease or other cardio-respiratory or neuromuscular pathology
  • Middle ear pathology
  • A known history of alcohol use
  • Treatment with sedative hypnotic agents or vasodilators
  • Having contraindications to spinal anesthesia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Pethidine 0.4mg/kg iv
interventional: Pethidine 0.4mg/kg intravenous bolus once to be repeated if shivering incompletely abolished.
Drug: Pethidine 0.4mg/kg
2ml intravenous bolus slowly injected in 2minutes.
Other Names:
  • Meperidine
ACTIVE_COMPARATOR: DEX. I
Interventional:Dexmedetomidine (Precedex) 0.5µg/kg intravenous bolus once to be repeated if shivering incompletely abolished.
Drug: Dexmedetomidine
2ml intravenous bolus slowly injected in 2minutes
Other Names:
  • Precedex
ACTIVE_COMPARATOR: DEX. II
Interventional: Dexmedetomidine (PRECEDEX) 0.3µg/kg intravenous bolus given once to be repeated if shivering incompletely abolished.
Drug: Dexmedetomidine
2ml intravenous bolus slowly injected in 2minutes
Other Names:
  • Precedex
ACTIVE_COMPARATOR: DEX III
Interventional: Dexmedetomidine (PRECEDEX) 0.2µg/kg intravenous bolus given once to be repeated if shivering incompletely abolished.
Drug: Dexmedetomidine
2ml intravenous bolus slowly injected in 2minutes
Other Names:
  • Precedex

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Shivering response rate (%)
Time Frame: 10 minutes
complete cessation of shivering activity within 10 minutes after study drug injection
10 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Systolic blood pressure
Time Frame: 6 hours after study drug injection
find for systolic hypotension, hypertension
6 hours after study drug injection
sedation
Time Frame: 6 hours after study drug injection
using an Observer's Assessment of Alertness/Sedation Scale (OAA/SS) (where 5 = Responds readily to name spoken in normal tone, 4 = Lethargic response to name spoken in normal tone, 3 = Responds only after name is spoken loudly and/or repeatedly, 2 = Responds only after mild prodding or shaking, 1 = Does not respond to mild prodding or shaking).
6 hours after study drug injection
peripheral arterial saturation
Time Frame: 6 hours after study drug injection
find for hypoxia
6 hours after study drug injection
diastolic blood pressure
Time Frame: 6 hours after study drug injection
find for diastolic hypertension or hypotension
6 hours after study drug injection
Postoperative adverse events
Time Frame: 24 hours postoperative
postoperative nausea and vomiting, urine retention, post dural puncture headache ect.
24 hours postoperative

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
heart rate
Time Frame: 6 hours after study drug injection
find for bradycardia or tachycardia
6 hours after study drug injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Principal Investigator: Hala S Abdel-Ghaffar, MD, assistant professor in anesthesia, faculty of medicine, Assiut university, Assiut, Egypt

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2013

Primary Completion (ACTUAL)

December 1, 2014

Study Completion (ACTUAL)

December 1, 2014

Study Registration Dates

First Submitted

February 25, 2015

First Submitted That Met QC Criteria

March 3, 2015

First Posted (ESTIMATE)

March 6, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

March 6, 2015

Last Update Submitted That Met QC Criteria

March 3, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00008718 (Registry Identifier: Assiut University)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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