Can a drug combo prevent dangerous heart spikes during anesthesia?
NCT ID NCT07783256
First seen Aug 24, 2026 · Last updated Aug 25, 2026 · Updated 1 time
Summary
This trial tests whether a single IV dose of ketodex (ketamine plus dexmedetomidine) or ketofol (ketamine plus propofol) better controls the heart rate and blood pressure spikes that often happen when a breathing tube is placed during anesthesia. The study includes 70 adults aged 18–60 having elective middle ear surgery, all in good health aside from their ear condition. Researchers will measure heart rate during intubation to see which combination offers steadier control.
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 plus dexmedetomidine) or ketofol (ketamine plus propofol), given as a single IV bolus before intubation
- What this could lead to
- If one combination works better, it could become a standard way to prevent dangerous spikes in heart rate and blood pressure during anesthesia for surgery.
- What could go wrong
- This is a small, early-stage trial, and results may not apply to all patients. Both drugs can have side effects, and the best option may not be clearly better.
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
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 70 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Dec 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 60 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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: * Adult patients scheduled for elective middle ear surgery under general anesthesia, ASA status I-II, aged from 18 to 60 years old of either sex. Exclusion Criteria: * Full stomach or emergency surgery * Any known contraindications or allergy to ketamine, dexmedetomidine, or propofol * Pregnancy or breastfeeding women * Body mass index (BMI) \> 35 Kg/m2 * History of hepatic, renal, or cardiac disease * Patients in whom the duration of laryngoscopy will last more than 25 seconds * Chronic opioid use, or history of neuropsychiatric disorders * Patient refusal
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As listed by the trial registrant
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How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
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