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Alpha-2 Adrenergic Agonist

Dexmedetomidine for Surgical Shivering

Phase 4
Recruiting
Led By Hans Sviggum, MD
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Singleton gestation in the 3rd trimester (28-42 weeks gestation).
Women presenting for planned cesarean delivery.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during intraoperative course
Awards & highlights

Study Summary

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

Who is the study for?
This trial is for women having a planned cesarean delivery under spinal anesthesia, with an ASA status of 2 or 3 and no major health issues. They must be in their third trimester without signs of infection or preterm rupture of membranes (PPROM), able to consent, and not have taken certain sedatives or have allergies to dexmedetomidine.Check my eligibility
What is being tested?
The study aims to find the best dose of Dexmedetomidine that stops shivering in 90% of patients during elective cesarean deliveries. It's focused on those who experience shivering as a side effect from the operation.See study design
What are the potential side effects?
Dexmedetomidine may cause side effects such as low blood pressure, slow heart rate, dry mouth, nausea, drowsiness. The exact side effects will depend on how much is given.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am in my third trimester of a single pregnancy.
Select...
I am a woman scheduled for a cesarean delivery.
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I am in fair to severe health but without major health problems.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 minutes after administration of the drug
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 minutes after administration of the drug for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Shivering will be graded using a five-point scale as outlined by Crossley and Mahajan
Secondary outcome measures
Doses of dexmedetomidine
Maternal Heart Rate

Side effects data

From 2020 Phase 4 trial • 798 Patients • NCT02004613
57%
Clinically important hypotension
9%
Clinically important bradycardia
1%
infection
1%
stroke
1%
Atelectasis
1%
Hemorrhage
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Dexmedetomidine

Trial Design

1Treatment groups
Experimental Treatment
Group I: DexmedetomidineExperimental Treatment1 Intervention
IV administration of Dexmedetomidine, using an Up-Down method utilizing a biased coin design to determine that next patient's dose. Initial dose will be 10mcg.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexmedetomidine
FDA approved

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,212 Previous Clinical Trials
3,766,998 Total Patients Enrolled
Hans Sviggum, MDPrincipal InvestigatorMayo Clinic

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this experiment currently looking for participants?

"According to the data on clinicaltrials.gov, this trial is currently open for recruitment and was first published in September 2021. The most up-to-date information about the study can be found from its revised version dated at September 2022."

Answered by AI

Has Dexmedetomidine been tested in other medical experiments?

"At present, there are 110 active studies in progress concerning Dexmedetomidine. Of these, 23 have reached Phase 3 and 207 sites around the world are contributing to this research with Karachi being the primary location."

Answered by AI

Has the Federal Drug Administration approved Dexmedetomidine for public use?

"With clinical approval and data supporting safety, dexmedetomidine is rated a 3 on our scale."

Answered by AI

What ailments can Dexmedetomidine be used to mitigate?

"Dexmedetomidine is an effective medication for treating pathologies and various maladies, such as ventilations, mechanical intubations, and cyclic vomiting syndrome."

Answered by AI

How many people are eligible to take part in the experiment?

"Affirmative, according to information from clinicaltrials.gov this research project is currently recruiting participants. It was initially uploaded on the 21st of September 2021 and has recently been modified on 26th of September 2022. 40 willing individuals are being sought for participation at one location."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Dexmedetomidine for Intraoperative Shivering in Scheduled Elective Cesarean Delivery
Hans P. Sviggum, M.D. 2021. "Dexmedetomidine for Intraoperative Shivering in Scheduled Elective Cesarean Delivery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04730609.
~4 spots leftby Aug 2024
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