Comparing wake-up and recovery after long spinal surgery with IV-only anesthesia versus IV plus low-dose sevoflurane or desflurane.
Effect of Combined Intravenous-Inhalational Anesthesia (CIVIA) on Postoperative Recovery Patterns.
This will test whether adding low-dose sevoflurane or desflurane to IV anesthesia helps adults having elective spinal surgery longer than three hours wake up and recover faster than IV-only anesthesia.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 210 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Kocaeli City Hospital Government |
| Locations | 1 site (Kocaeli, Izmıt) |
| Trial ID | NCT07123870 on ClinicalTrials.gov |
What this trial studies
This single-center, prospective, randomized Phase 4 trial enrolls adults undergoing elective spinal surgery expected to last more than three hours and uses intraoperative neuromonitoring. Participants are randomized to one of three anesthesia approaches: TIVA with propofol-remifentanil using TCI (Eleveld model) and BIS guidance, TIVA plus low-dose sevoflurane (sevoflurane-CIVIA), or TIVA plus low-dose desflurane (desflurane-CIVIA). The study measures recovery parameters including time to eye opening, extubation time, emergence agitation (Richardson and Ramsey scales), postoperative nausea and vomiting, time to Aldrete >9, and PACU discharge time. The goal is to compare whether adding 0.5 MAC of sevoflurane or desflurane to TIVA shortens recovery or changes emergence quality compared with TIVA alone.
Who should consider this trial
Good fit: Adults over 18 scheduled for elective spine surgery expected to last more than three hours with planned TIVA, BIS-guided anesthesia, and intraoperative neuromonitoring are ideal candidates.
Not a fit: Patients undergoing emergency surgery, those receiving only inhaled anesthesia without TIVA, or those with major intraoperative complications (e.g., severe hypotension or perioperative dural injury) are unlikely to benefit from the study interventions.
Why it matters
Potential benefit: If successful, patients could experience faster emergence, less emergence agitation, and shorter PACU stays.
How similar studies have performed: Prior work has shown desflurane often produces faster immediate emergence than sevoflurane or TIVA, but combining low-dose inhaled agents with TIVA (CIVIA) for prolonged spine procedures is less well studied.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Scheduled for spine surgery * Expected surgery duration longer than 3 hours * Use of intraoperative neuromonitoring * BIS-guided anesthesia administered * TIVA (with TCI) as the primary anesthetic technique * Age \>18 years Exclusion Criteria: * Emergency surgeries * Patients receiving sole inhaled anesthesia (no TIVA) * Perioperative dural injury * Intraoperative severe hypotension requiring inotropic support * Hypothermia (based on temperature measured before recovery)
Where this trial is running
Kocaeli, Izmıt
- Kocaeli City Hospital — Kocaeli, Izmıt, Turkey (Türkiye) (Recruiting)
Study contacts
- Principal investigator: Ahmet YUKSEK, Md — Kocaeli City Hospital
- 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.