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NCT06741930CompletedPhase 4

Pro-Epileptic Effects of IV Ketamine

Potential Pro-Convulsive Properties of Ketamine and Its Effects on EEG During Procedural Sedation: A Comparative Evaluation With Midazolam and Propofol

Source: ClinicalTrials.gov · Last updated 15 Dec 2025

Brief summary (registry, in English)

The investigators evaluated the safety and potential pro-epileptic effects of intravenous (IV) ketamine during procedural sedation in comparison with IV midazolam and IV propofol. Specifically, the study hypothesizes that IV ketamine, at doses used for procedural sedation, exhibits pro-convulsive properties, lowers the epileptic seizure threshold, and may induce interictal epileptiform discharges and/or seizures. Additionally, the investigators assessed the effects of these sedative agents on electroencephalographic (EEG) activity during procedural sedation.

Status (registry)
Completed
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
300 (actual)
First submitted
18 Dec 2024
Start date
1 Dec 2024
Primary completion date
30 Aug 2025
Lead sponsor
Haseki Training and Research Hospital
Diseases
Epilepsy
NCT number
NCT06741930

What you commit to

  • Study type: Interventional · Phase 4
  • Participants enrolled: 300
  • From 1 Dec 2024 to the primary completion date, 30 Aug 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • patients with a known history of epilepsy, previous status epilepticus, or neurological conditions such as head trauma, brain tumors, cerebrovascular events, meningitis, or encephalitis, as well as congenital or acquired structural brain anomalies.
  • Individuals with a first-degree family history of epilepsy or who had used medications affecting the central nervous system (e.g., antidepressants, antipsychotics, sedatives, benzodiazepines, or opioids) within the previous month were also excluded.
  • Patients with a history of complications during anesthesia or previous surgical procedures, such as malignant hyperthermia or respiratory failure.
  • Patients with severe hepatic or renal failure, or those who had undergone major surgery within the previous 6 months.

Other illness

  • Patients were also excluded if they had a known allergy or hypersensitivity to the study drugs (IV ketamine, IV midazolam, IV propofol) or to adjunctive medications used for procedural sedation (e.g., IV fentanyl).
  • Patients with significant movement disorders, agitation, scalp lesions, or other conditions interfering with EEG recording.
  • Patients with severe cardiovascular disease, including uncontrolled hypertension, advanced heart failure, or arrhythmias, as well as those with oxygen saturation \<90%, a high risk of respiratory depression, or severe obstructive sleep apnea syndrome.

Age

  • patients aged \<18 years,

Other

  • pregnant or breastfeeding females,

Who the study is looking for

  • \- Adults aged ≥18 years scheduled to undergo procedural sedation prior to esophagogastroduodenoscopy in the endoscopy unit were included in the study.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Haseki Training and Research Hospital
Coordinator of this site? Confirm its status
IstanbulTurkey (Türkiye)Unknown status

This page is information, not medical advice. Discuss any trial with your doctor.