Dexmedetomidine for Shivering

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
Shivering+1 MoreDexmedetomidine - Drug
Eligibility
18+
Female
What conditions do you have?
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Study Summary

This trial is testing whether a common sedative can help stop shivering during surgery.

Eligible Conditions
  • Shivering
  • Dose Finding Study

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Study Objectives

1 Primary · 2 Secondary · Reporting Duration: During intraoperative course

5 minutes after administration of the drug
Shivering will be graded using a five-point scale as outlined by Crossley and Mahajan
During intraoperative course
Doses of dexmedetomidine
Maternal Heart Rate

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Side Effects for

Dexmedetomidine
57%Clinically important hypotension
9%Clinically important bradycardia
1%Atelectasis
1%stroke
1%infection
1%Hemorrhage
This histogram enumerates side effects from a completed 2020 Phase 4 trial (NCT02004613) in the Dexmedetomidine ARM group. Side effects include: Clinically important hypotension with 57%, Clinically important bradycardia with 9%, Atelectasis with 1%, stroke with 1%, infection with 1%.

Trial Design

1 Treatment Group

Dexmedetomidine
1 of 1

Experimental Treatment

40 Total Participants · 1 Treatment Group

Primary Treatment: Dexmedetomidine · No Placebo Group · Phase 4

Dexmedetomidine
Drug
Experimental Group · 1 Intervention: Dexmedetomidine · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexmedetomidine
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: during intraoperative course

Who is running the clinical trial?

Mayo ClinicLead Sponsor
2,917 Previous Clinical Trials
3,506,848 Total Patients Enrolled
Hans Sviggum, MDPrincipal InvestigatorMayo Clinic

Eligibility Criteria

Age 18+ · Female Participants · 5 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are pregnant with a baby whose gestational age is between 28 and 42 weeks.
Women presenting for planned cesarean delivery should be offered spinal anesthesia.