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New combo sedation tested for brain surgery patients

NCT ID NCT07513935

Symptom relief Sponsor: Ain Shams 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether a combination of two sedatives (ketamine and dexmedetomidine, called Ketodex) works better than dexmedetomidine alone for keeping patients comfortable during awake deep brain stimulation surgery. The surgery is used for movement disorders like Parkinson's disease. Twenty-four adults will be randomly assigned to one of the two sedation groups, and researchers will measure how well the brain signals are recorded and how much extra pain medicine is needed.

What this could mean

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

Active substance
Ketodex (ketamine and dexmedetomidine combination)
What this could lead to
If successful, this could show that adding ketamine to dexmedetomidine provides better sedation and comfort during awake brain surgery without interfering with brain recordings.
What could go wrong
This is a small Phase 4 trial with only 24 participants, so results may not apply to everyone. The study is also not recruiting, meaning findings may take time to confirm.

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

24 people

The number who actually took part.

Started

Mar 2026

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 to 75 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * Age 18-75 years. * American Society of Anesthesiologists (ASA) physical status I, II, or III. * Ability to give informed consent and cooperate with the procedure (e.g., follow commands, perform intraoperative tasks). Exclusion Criteria: * Contraindications to the study drugs (dexmedetomidine or ketamine). * Severe cardiac, respiratory, or hepatic disease. * Pre-existing psychological/psychiatric disorders that may interfere with intraoperative assessment (e.g., severe dementia, psychosis). * Allergy to local anesthetics. * Emergency surgery or previous DB * Electrocardiogram (ECG) showing heart block of any degree * heart failure, * liver cirrhosis, thrombocytopenia and coagulopathies, * severe bradycardia,

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Conditions

The condition(s) this trial relates to.

essential tremor Intraoperative Awareness Parkinson disease

As listed by the trial registrant

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

Intraoperative awareness

Contacts and locations

Locations

  • Ainshams University

    Cairo, Egypt

More trials for these conditions

Other studies related to the condition(s) this trial covers.