Comparing two methods of anesthesia to reduce awareness and dreaming during surgery
Official title: Reduction of Awareness and Dreaming During Neurosurgical Procedures Using Target- Controlled Infusion, Comparison With Manual Total Intravenous Anesthesia TIVA.
Run by University Hospital Hradec Kralove · NCT03476213 · Data updated 2026-11-12
This study is testing two different ways to give anesthesia during brain surgery to see which one helps patients avoid awareness and dreaming while they are under.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 80 (estimated) |
| Sponsor | University Hospital Hradec Kralove Academic / other |
| Locations | 1 site (Hradec Králové) |
| Status | Recruiting |
| Started | March 16, 2018 |
| Main results expected | December 15, 2025 |
| Study ends | June 30, 2027 |
| Registry record updated | May 10, 2024 |
| Trial ID | NCT03476213 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults with a Glasgow Coma Scale score of 15, classified as ASA Physical Status I-III, and scheduled for elective brain tumor surgery lasting up to 5 hours.
✕Probably not a fit
Patients with severe cardiac conditions, substance abuse issues, or those requiring awake operations may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study compares two techniques of total intravenous anesthesia (TIVA) to assess their effectiveness in reducing awareness and dreaming during elective neurosurgical procedures. Patients will be randomly assigned to receive either manual TIVA or target-controlled infusion (TCI) anesthesia. The study aims to evaluate not only the incidence of awareness and dreaming but also the hemodynamic stability of patients during surgery. A total of 80 patients scheduled for brain tumor resection will participate, with assessments conducted postoperatively using the Modified Brice Questionnaire.
Why it matters
Potential benefit: If successful, this study could lead to improved anesthesia techniques that minimize awareness and dreaming during surgery, enhancing patient comfort and safety.
How similar studies have gone: Previous studies have shown promising results with target-controlled infusion techniques in anesthesia, suggesting potential benefits in reducing awareness.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Glasgow Coma scale 15 * ASA Physical Status Classification System I - III * planed surgery for brain tumor to 5 hours * postoperative awakening Exclusion Criteria: * NYHA III, IV * abuse of stimulating drugs, grass, alcohol dependence * BMI over 40 in females and over 35 in men * propofol alergie * awake operations * postoperative arteficial ventilation
Where it's running
-
University Hospital Hradec Kralove
Hradec Králové, Czechia Recruiting
Study contacts
- Study coordinator: Vlasta Dostalova, MD. Ph.D.
- Email: vlasta.dostalova@fnhk.cz
- Phone: +420777883571
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.