NCT02382432

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Dec 2013

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2013

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 25, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 6, 2015

Completed
Last Updated

March 6, 2015

Status Verified

March 1, 2015

Enrollment Period

1 year

First QC Date

February 25, 2015

Last Update Submit

March 3, 2015

Conditions

Shivering Caused by Spinal Anesthesia

Keywords

Anesthesiadexmedetomidinepethidineshiveringspinal

Outcome Measures

Primary Outcomes (1)

  • Shivering response rate (%)

    complete cessation of shivering activity within 10 minutes after study drug injection

    10 minutes

Secondary Outcomes (5)

  • Systolic blood pressure

    6 hours after study drug injection

  • sedation

    6 hours after study drug injection

  • peripheral arterial saturation

    6 hours after study drug injection

  • diastolic blood pressure

    6 hours after study drug injection

  • Postoperative adverse events

    24 hours postoperative

Other Outcomes (1)

  • heart rate

    6 hours after study drug injection

Study Arms (4)

Pethidine 0.4mg/kg iv

ACTIVE COMPARATOR

interventional: Pethidine 0.4mg/kg intravenous bolus once to be repeated if shivering incompletely abolished.

Drug: Pethidine 0.4mg/kg

DEX. I

ACTIVE COMPARATOR

Interventional:Dexmedetomidine (Precedex) 0.5µg/kg intravenous bolus once to be repeated if shivering incompletely abolished.

Drug: Dexmedetomidine

DEX. II

ACTIVE COMPARATOR

Interventional: Dexmedetomidine (PRECEDEX) 0.3µg/kg intravenous bolus given once to be repeated if shivering incompletely abolished.

Drug: Dexmedetomidine

DEX III

ACTIVE COMPARATOR

Interventional: Dexmedetomidine (PRECEDEX) 0.2µg/kg intravenous bolus given once to be repeated if shivering incompletely abolished.

Drug: Dexmedetomidine

Interventions

Pethidine 0.4mg/kgDRUG

2ml intravenous bolus slowly injected in 2minutes.

Also known as: Meperidine
Pethidine 0.4mg/kg iv
DexmedetomidineDRUG

2ml intravenous bolus slowly injected in 2minutes

Also known as: Precedex
DEX IIIDEX. IDEX. II

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut university hospital, Assiut, Egypt

Asyut, Assiut Governorate, 715715, Egypt

Location

Related Publications (1)

  • Abdel-Ghaffar HS, Mohamed SA, Fares KM, Osman MA. Safety and Efficacy of Dexmedetomidine in Treating Post Spinal Anesthesia Shivering: A Randomized Clinically Controlled Dose-Finding Trial. Pain Physician. 2016 May;19(4):243-53.

    PMID: 27228512DERIVED

MeSH Terms

Interventions

MeperidineDexmedetomidine

Intervention Hierarchy (Ancestors)

Isonipecotic AcidsAcids, HeterocyclicHeterocyclic CompoundsPiperidinesHeterocyclic Compounds, 1-RingImidazolesAzoles

Study Officials

  • Hala S Abdel-Ghaffar, MD

    assistant professor in anesthesia, faculty of medicine, Assiut university, Assiut, Egypt

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor in anesthesia department, faculty of medicine, Assiut university

Study Record Dates

First Submitted

February 25, 2015

First Posted

March 6, 2015

Study Start

December 1, 2013

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

March 6, 2015

Record last verified: 2015-03

Locations

EG(1)