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New study aims to stop shivering in C-Section patients

NCT ID NCT04730609

Symptom relief Sponsor: Mayo Clinic Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled This study
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Sep 18, 2026 · Updated 2 times

Summary

This study tests different doses of dexmedetomidine to find the amount that stops shivering in 90% of women having planned C-sections. Forty healthy mothers with a single baby will receive the drug during spinal anesthesia. The goal is to improve comfort without causing unwanted side effects like slow heart rate or excessive sleepiness.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Dexmedetomidine
What this could lead to
If successful, this could provide a reliable way to stop shivering during C-sections, improving comfort for mothers.
What could go wrong
This is a small, early-phase dose-finding study with only 40 participants, so results may not apply broadly. Side effects like changes in heart rate or sedation are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Expected to start

Sep 2021

An estimate. Start dates often move.

Expected to finish

Sep 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Women presenting for planned cesarean delivery. * American Society of Anesthesiology Physical Classification Status 2 or 3; without major medical co-morbidities. * Singleton gestation in the 3rd trimester (28-42 weeks gestation). * Spinal anesthesia technique Women presenting for planned cesarean delivery. * American Society of Anesthesiology Physical Classification Status 2 or 3; without major medical co-morbidities. * Singleton gestation in the 3rd trimester (28-42 weeks gestation). * Spinal anesthesia technique. Exclusion Criteria: * Any contraindication to spinal anesthesia technique. * Allergy or intolerance to dexmedetomidine or clonidine. * Oral temperature \< 36° Celsius prior to procedure. * Unable to give personal consent. * PPROM or concern for infection (e.g., chorioamnionitis). * Conversion to General Anesthesia prior to randomization. * Sedative medications (e.g., fentanyl, midazolam, ketamine, nitrous oxide) administered prior to randomization.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Dose finding study Shivering

Contacts and locations

Locations

  • Mayo Clinic in Rochester

    Rochester, Minnesota, 55905, United States

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