Monitoring anesthesia depth to reduce recovery agitation in spinal surgeries
Bispectral Index and Emergence Agitation in Spinal Surgeries
This study is testing if using a special monitor to check anesthesia levels can help reduce confusion and agitation in adults recovering from spinal surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Bozok University Academic / other |
| Locations | 1 site (Kocaeli) |
| Trial ID | NCT06217341 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the relationship between bispectral index (BIS) monitoring and emergence agitation during the recovery period after spinal surgeries. It focuses on patients undergoing lumbar disc herniation surgery, utilizing BIS to assess the depth of anesthesia through electroencephalogram (EEG) data. By continuously monitoring the patient's consciousness level, the study aims to optimize anesthesia management and minimize complications related to recovery agitation. The study will include patients aged 18 and older with specific health criteria, ensuring a controlled environment for evaluating the effectiveness of BIS monitoring.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 undergoing lumbar disc herniation surgery with an ASA score of 1-2 and no neurological or vascular diseases.
Not a fit: Patients who experience intraoperative complications or those who do not wish to participate will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved recovery experiences for patients by reducing emergence agitation after anesthesia.
How similar studies have performed: While BIS monitoring is commonly used, this specific investigation into its impact on emergence agitation is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 1. Patients who will undergo lumbar disc herniation surgery in Kocaeli city hospital operating rooms will be included in our study after ethics committee approval. 2. Patients over the age of 18 will be included in the study. 3. Patients with an ASA score of 1-2 and without neurological disease will be included. 4.Patients without known vascular diseases will be included. 5. Study patients will receive routine anesthesia premedication and routine analgesics, and patients with different procedures will not be included in the study. Exclusion Criteria: * 1. Patients who do not want to participate in the study will not be included. 2. Patients with intraoperative profound hypotension (mean arterial pressure \<50) will be excluded. 3. Those who develop intraoperative hypothermia or other anesthesia complications will be removed. 4. Patients who will not be extubated postoperatively will be excluded from the study. 5. Those with neurological diseases or using psychiatric medications will also be excluded from the study.
Where this trial is running
Kocaeli
- Kocaeli City Hospital — Kocaeli, Turkey (Recruiting)
Study contacts
- Study coordinator: Ahmet YUKSEK, Md
- Email: mdayuksek@hotmail.com
- Phone: 05326580351
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.