Effect of Combined Intravenous-Inhalational Anesthesia (CIVIA) on Postoperative Recovery Patterns.
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 210
- Locations
- 2
- Primary Endpoint
- Extubation time
Study Overview
Brief Summary
This study was planned as a single-center, prospective, randomized trial. Adult patients undergoing elective spinal surgery lasting longer than three hours, performed in a neurosurgery operating room, will be evaluated. Patients managed with three different anesthesia methods currently used will be examined for recovery patterns:
- Total intravenous anesthesia (TIVA),
- TIVA Combined anesthesia with sevoflurane and intravenous agents (sevoflurane-CIVIA),
- TIVA Combined anesthesia with desflurane and intravenous agents (desflurane-CIVIA).
Recovery patterns include; extubation time, eye opening time, emergence agitation, postoperative nausia and vomiting and postoperative recovery unit discharge time.
Detailed Description
The aim of this study was to compare the effects of different anesthesia methods applied in spinal surgeries lasting longer than three hours on postoperative recovery time. Specifically, it aimed to determine the contribution of low-dose (0.5 MAC) desflurane or sevoflurane combined intravenous anesthesia (CIVIA) approaches compared to total intravenous anesthesia (TIVA) on recovery parameters such as patient recovery time, extubation time, and time to consciousness. It also aimed to investigate whether the desflurane-containing combination resulted in a faster recovery than the sevoflurane-containing combination.
TIVA will be administered using target-controlled infusion (TCI) with the Eleveld pharmacokinetic efect site model, utilizing a propofol-remifentanil combination, and guided by BIS monitoring.
Outputs:
Eye opening time (the time from the end of anesthesia until the patient's eye opening for verbal stimuli) Extubation time (the time from the end of anesthesia until extubation) Richardson agitation sedation and RAMSEY scale values, and Emergence agitation incidence.
Postoperative nausea and vomiting incidence (PONV). Time to discharge from the PACU and time to an Aldrate score >9 will be calculated.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Care Provider)
Masking Description
Participant: The participant will be unaware of which anesthesia method is involved in the perioperative period.
Care Provider: The second anesthesiologist is responsible for the patient's recovery after the anesthesia is terminated and will be unaware of which anesthetic method was used.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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)
Arms & Interventions
TIVA
Total Intravenous Anesthesia. TIVA will be administered using target-controlled infusion (TCI) with the Eleveld pharmacokinetic model, utilizing a propofol-remifentanil combination, and guided by BIS monitoring. Efect Site concentration will be aimed. for sole TIVA, 2-4mcg/ml propofol and 1-4ng/ml remifentanil will bu used according to BIS monitoring. 40-60 range will be used for BIS.
Intervention: Total Intravenous Anesthesia(TIVA) (Drug)
Sevoflurane combined with TIVA
Combined anesthesia with sevoflurane and intravenous agents. A 0.5 MAC sevoflurane combined with TIVA. TIVA will be administered using target-controlled infusion (TCI) with the Eleveld pharmacokinetic model, utilizing a propofol-remifentanil combination, and guided by BIS monitoring.
Intervention: Sevofluorane (Drug)
Desflurane combined with TIVA
Combined anesthesia with desflurane + intravenous agents. TIVA will be administered using target-controlled infusion (TCI) with the Eleveld pharmacokinetic model, utilizing a propofol-remifentanil combination, and guided by BIS monitoring. Efect site concentration will be aimed for TIVA
Intervention: Desflurane (Drug)
Outcomes
Primary Outcomes
Extubation time
Time Frame: First postoperative hour
Extubation time in patients after all anesthetic drugs have been discontinued
Extubation time
Time Frame: First postoperative hour
Extubation time in patients after all anesthetic drugs have been discontinued
Secondary Outcomes
- Eye opening(First postoperative hour)
- Eye opening(First postoperative hour)
Investigators
Ahmet Yuksek
Clinical Professor
Kocaeli City Hospital