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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

210 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-23

Study Completion Date

2025-11-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Desflurane and Sevoflurane Minimal Flow Anesthesia on Recovery and Anesthetic Depth

NCT05024084

Anesthesia

UNKNOWN PHASE4

Effects of Sevoflurane vs Desflurane on Early Recovery and Cognitive Function in Elderly Patients Undergoing Scheduled Non-Cardiac Surgery

NCT07289945

Early Recovery in Elderly Patients Cognitive Function

COMPLETED PHASE3

Blood Levels of Sevoflurane and Desflurane

NCT03015350

Anesthetics, Inhalation

COMPLETED

The Effect of Sevoflurane on Cerebral CO2 Sensitivity and Systemic Arteries

NCT02054143

Sevoflurane Anesthesia

COMPLETED PHASE4

Comparison of Volatile Anesthetics on Cerebral Oxygenation During Controlled Hypotension

NCT02834845

Oxygen Saturation

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Postoperative Recovery Inhalation Anesthesia Total Intravenous Anesthesia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

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.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Sevofluorane

Intervention Type DRUG

In this group of patients, \<0.5 MAC sevoflurane will be used in combination with TIVA. (TIVA method described above)

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

Group Type EXPERIMENTAL

Desflurane

Intervention Type DRUG

In this group of patients, \<0.5 MAC Desflurane will be used in combination with TIVA.

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.

Group Type EXPERIMENTAL

Total Intravenous Anesthesia(TIVA)

Intervention Type DRUG

In this group, TIVA will be applied with the combination of BIS-guided propofol + remifentanil.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Sevofluorane

In this group of patients, \<0.5 MAC sevoflurane will be used in combination with TIVA. (TIVA method described above)

Intervention Type DRUG

Desflurane

In this group of patients, \<0.5 MAC Desflurane will be used in combination with TIVA.

Intervention Type DRUG

Total Intravenous Anesthesia(TIVA)

In this group, TIVA will be applied with the combination of BIS-guided propofol + remifentanil.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Sevoflurane Combined Anesthesia Desflurane Combined anesthesia Total Intravenous Anesthesia

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes