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Can a simple drug stop shivering during surgery? new trial aims to find out

NCT ID NCT07300826

Symptom relief Sponsor: Assiut University 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 This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests two common sedatives, dexmedetomidine and midazolam, to see which better prevents shivering in trauma patients having lower leg surgery under spinal anesthesia. Shivering affects up to 60% of these patients and can cause discomfort and complications. The trial will enroll 100 adults and monitor shivering during and after surgery.

What this could mean

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

Active substance
Dexmedetomidine and midazolam
What this could lead to
If this trial succeeds, it could show that one of these drugs is better at preventing shivering during surgery, improving patient comfort and safety.
What could go wrong
This is a small, early-phase trial with only 100 participants, so results may not apply to all patients. Shivering prevention is a secondary benefit, not a cure.

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.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jan 2026

An estimate. Start dates often move.

Expected to finish

Apr 2027

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 to 60 years

Sex

Anyone

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: * : ASA I-II Adult trauma patients (age 18-60 years). Undergoing lower limb orthopedic surgery with tourniquet under spinal anesthesia Exclusion Criteria: \- Allergy to study drugs. Severe cardiovascular, hepatic, or renal disease Hypovolemic shock. History of psychiatric illness or chronic sedative use. Bradycardia (\<50 bpm), heart block, or uncontrolled hypotension. Febrile illness or use of active warming devices

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As listed by the trial registrant

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

Lower limb orthopedic surgery

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  2. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.