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Can Computer-Controlled sedation reduce breathing risks during spine surgery?

NCT ID NCT07745348

Knowledge-focused Sponsor: Marmara University Pendik Training and Research Hospital 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 04, 2026 · Last updated Aug 05, 2026 · Updated 1 time

Summary

This study compares two ways of giving sedation during kyphoplasty, a procedure to treat spinal fractures, performed while the patient lies face down. One method uses a computer-controlled infusion of the sedative propofol, while the other relies on manual dosing. The main goal is to see which approach leads to fewer episodes of low oxygen or pauses in breathing. The trial also looks at how quickly patients wake up and recover, as well as satisfaction from both patients and surgeons.

What this could mean

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

Active substance
Target-controlled infusion (TCI) of propofol compared with manually administered total intravenous anesthesia (TIVA)
What this could lead to
If TCI proves safer, it could become the preferred sedation method for spine surgeries, reducing breathing complications and improving recovery.
What could go wrong
This is a small, single-center study, so results may not apply broadly. Individual responses to sedation vary, and the study does not guarantee a clear advantage for TCI.

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.

Participants

About 50 people

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

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Aug 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.

Who is studied

Patients aged 18 and over scheduled kyphoplasty in prone position

Ages

18 years and older

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 years and older * ASA physical status classification I-III * Scheduled for kyphoplasty under sedation in the prone position * Provision of written informed consent Exclusion Criteria: * Known allergy to any of the study medications * ASA physical status classification IV or higher * Patients deemed unsuitable for sedation (high pulmonary risk, morbid obesity, diagnosed severe obstructive sleep apnea) * Refusal to participate or withdrawal of consent * Diagnosis of dementia or Alzheimer's disease * Communication difficulties precluding adequate assessment

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As listed by the trial registrant

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

End tidal carbon dioxide Kyphoplasty Prone position Target controlled infusion of propofol

How to take part

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

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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.

Contacts and locations

Locations

  • Seniyye Ülgen Zengin

    Istanbul, Maltepe, 34854, Turkey (Türkiye)

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