Effect of Combined Intravenous-Inhalational Anesthesia (CIVIA) on Postoperative Recovery Patterns.

Kocaeli City Hospital

Status and phase: Enrolling; Phase 4

Conditions: Postoperative Recovery; Total Intravenous Anesthesia; Inhalation Anesthesia

Treatments: Drug: Total Intravenous Anesthesia(TIVA); Drug: Sevofluorane; Drug: Desflurane

Study type: Interventional

Funder types: Other

Identifiers

NCT07123870

KAEK/10.bI.02

Details and patient eligibility

About

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:

1. Total intravenous anesthesia (TIVA),
2. TIVA Combined anesthesia with sevoflurane and intravenous agents (sevoflurane-CIVIA),
3. 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.

Full 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.

Enrollment: 210 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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210 participants in 3 patient groups

Sevoflurane combined with TIVA

Experimental group

Description:

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.

Treatment:

Drug: Sevofluorane

Desflurane combined with TIVA

Experimental group

Description:

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

Treatment:

Drug: Desflurane

TIVA

Experimental group

Description:

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.

Treatment:

Drug: Total Intravenous Anesthesia(TIVA)