Evaluating the impact of anesthesia on recovery after brain surgery
FASt Track in Elective Neurosurgery: the Role of Low Propofol Bis-NOL Guided General Anaesthesia for Full, Early and Safe Awakening
This study is testing how different amounts of anesthesia during brain surgery affect how quickly patients wake up and recover afterward.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta Academic / other |
| Locations | 1 site (Milan) |
| Trial ID | NCT06844838 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess how different dosages of sedation during elective neurosurgery affect patients' awakening and recovery of consciousness. Over a 24-month period, data will be collected from patients undergoing supratentorial brain tumor surgery, focusing on preoperative clinical and socio-demographic information, as well as psychological variables. The study will utilize BIS-guided general anesthesia, monitoring various physiological parameters and assessing recovery through a structured awakening chart and patient interactions. The findings will contribute to understanding optimal anesthesia practices for improved patient outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older undergoing elective surgery for supratentorial brain tumors.
Not a fit: Patients with psychiatric illnesses, cognitive decline, or those under 18 years old may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance recovery protocols for patients undergoing brain surgery, leading to safer and quicker awakenings.
How similar studies have performed: While there have been studies on anesthesia and recovery, this specific approach using BIS-guided anesthesia in neurosurgery is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with supra- and sub tentorial neurosurgical pathology who meet the following inclusion criteria will be enrolled: * Age greater than or equal to 18 years Exclusion Criteria: * Psychiatric illness in history and/or taking psychotropic drugs * Glasgow Coma Score (GCS) \< 15 * Presence of overt cognitive decline or speech disorders * Patients younger than 18 years of age * Intraoperative hypothermia (\< 36°) * Intraoperative hypotension (MAP \< 20% of baseline)
Where this trial is running
Milan
- Fondazione IRCCS Istituto Neurologico Carlo Besta — Milan, Italy (Recruiting)
Study contacts
- Study coordinator: Carla Carozzi, M.D.
- Email: carla.carozzi@istituto-besta.it
- Phone: +39 02 2394
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.