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Pro-Epileptic Effects of IV Ketamine

NCT06741930 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2025-12-15

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Ketamine

The Ketamine group received IV ketamine at a titrated dose of 0.5-1.0 mg/kg with IV fentanyl, administered in small incremental boluses of 25-50 mcg to ensure adequate analgesia.

DRUG

Midazolam

The Midazolam group received IV midazolam at a titrated dose of 0.15-0.40 mg/kg with IV fentanyl, administered in small incremental boluses of 25-50 mcg to ensure adequate analgesia.

DRUG

Propofol

The Propofol group received IV propofol at a titrated dose of 0.5-1.0 mg/kg with IV fentanyl, administered in small incremental boluses of 25-50 mcg to ensure adequate analgesia.

Sponsors & Collaborators

  • Haseki Training and Research Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-01
Primary Completion
2025-08-30
Completion
2025-08-30
FDA Drug
Yes

Countries

  • Turkey (Türkiye)

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06741930 on ClinicalTrials.gov