NCT03530007

Brief Summary

Shivering is one of the most frequent complications occurring during or after spinal anesthesia with many side effects. The aim of the present study was to compare between two different doses of ondansetron for anti-shivering effect

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started May 2018

Shorter than P25 for phase_2

Status
unknown

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

First Submitted

Initial submission to the registry

May 8, 2018

Completed
7 days until next milestone

Study Start

First participant enrolled

May 15, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 21, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2018

Completed
Last Updated

May 21, 2018

Status Verified

May 1, 2018

Enrollment Period

3 months

First QC Date

May 8, 2018

Last Update Submit

May 17, 2018

Conditions

ShiveringOndansetron

Outcome Measures

Primary Outcomes (1)

  • incidence of shivering

    Incidence of shivering among patients in both groups

    for 24 hours after spinal anesthesia

Secondary Outcomes (4)

  • Axillary temperature

    for 24 hours after spinal anesthesia

  • core temperature

    for 24 hours after spinal anesthesia

  • incidence of hypotension

    for 24 hours after spinal anesthesia

  • incidence of nausea and vomiting

    for 24 hours after spinal anesthesia

Study Arms (3)

normal saline

ACTIVE COMPARATOR

patients received normal saline for prevention of shivering during spinal anesthesia

Drug: Normal saline

ondansetron 4MG

ACTIVE COMPARATOR

patients received 4 mg of ondansetron for prevention of spinal shivering

Drug: Ondansetron 4 MG

ondansetron 8MG

ACTIVE COMPARATOR

patients received 8 mg of ondansetron for prevention of spinal shivering

Drug: Ondansetron 8mg

Interventions

Normal salineDRUG

normal saline used for prevention of spinal shivering

Also known as: placebo
normal saline
Ondansetron 4 MGDRUG

ondansetron 4 MG used for prevention of spinal shivering

Also known as: low ondansetron
ondansetron 4MG
Ondansetron 8mgDRUG

ondansetron 8 MG used for prevention of spinal shivering

Also known as: high ondansetron
ondansetron 8MG

Eligibility Criteria

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

You may qualify if:

  • Age between 18-65 years
  • Both sexes
  • American Society of Anesthesiologists
  • physical status I and II
  • scheduled for lower limb surgery under spinal anesthesia

You may not qualify if:

  • Uncooperative patients
  • psychologically unstable patients
  • obese patients with BMI \>30 preoperative use of ondansetron, or opioids Fever Patients with some clinical conditions like hypo- or hyperthyroidism, Parkinson's disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Saline SolutionOndansetron

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical PreparationsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsCarbazolesIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds, 3-Ring

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer

Study Record Dates

First Submitted

May 8, 2018

First Posted

May 21, 2018

Study Start

May 15, 2018

Primary Completion

August 15, 2018

Study Completion

September 15, 2018

Last Updated

May 21, 2018

Record last verified: 2018-05