Comparing two methods of anesthesia to reduce awareness and dreaming during surgery
Reduction of Awareness and Dreaming During Neurosurgical Procedures Using Target- Controlled Infusion, Comparison With Manual Total Intravenous Anesthesia TIVA.
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital Hradec Kralove Academic / other |
| Locations | 1 site (Hradec Králové) |
| Trial ID | NCT03476213 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with severe cardiac conditions, substance abuse issues, or those requiring awake operations may not benefit from this study.
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 performed: Previous studies have shown promising results with target-controlled infusion techniques in anesthesia, suggesting potential benefits in reducing awareness.
Eligibility criteria
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 this trial is running
Hradec Králové
- University Hospital Hradec Kralove — Hradec Králové, Czechia (Recruiting)
Study contacts
- Study coordinator: Vlasta Dostalova, MD. Ph.D.
- Email: vlasta.dostalova@fnhk.cz
- Phone: +420777883571
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.