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

NCT07123870 | Recruiting Phase 4

• 1 other identifier: KAEK/10.bI.02
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

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:

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

Conditions

Postoperative Recovery; Inhalation Anesthesia; Total Intravenous Anesthesia

Keywords

CIVIA; TIVA; sevoflurane; desflurane; postoperative recovery

Outcome Measures

Primary Outcomes (1)

• Extubation time

  Extubation time in patients after all anesthetic drugs have been discontinued

  First postoperative hour

Secondary Outcomes (1)

• Eye opening

  First postoperative hour

Other Outcomes (3)

• Richmond Agitation-Sedation Scale (RASS)

  first 2 hours postoperatively

• Postoperative Nausia and Vomiting

  First 2 postoperative hours

• PACU discharge time

  First 2 postoperative hours

Study Arms (3)

Sevoflurane combined with TIVA

EXPERIMENTAL

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.

Drug: Sevofluorane

Desflurane combined with TIVA

EXPERIMENTAL

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

Drug: Desflurane

TIVA

EXPERIMENTAL

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.

Drug: Total Intravenous Anesthesia(TIVA)

Interventions

Sevofluorane DRUG

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

Also known as: Sevoflurane Combined Anesthesia

Sevoflurane combined with TIVA

Desflurane DRUG

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

Also known as: Desflurane Combined anesthesia

Desflurane combined with TIVA

Total Intravenous Anesthesia(TIVA) DRUG

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

Also known as: Total Intravenous Anesthesia

TIVA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Kocaeli City Hospital: lead

Study Sites (1)

Kocaeli City Hospital

Kocaeli, Izmıt, Yozgat, Turkey (Türkiye)

RECRUITING

Related Publications (3)

• Wolf A, Selpien H, Haberl H, Unterberg M. Does a combined intravenous-volatile anesthesia offer advantages compared to an intravenous or volatile anesthesia alone: a systematic review and meta-analysis. BMC Anesthesiol. 2021 Feb 15;21(1):52. doi: 10.1186/s12871-021-01273-1.

  PMID: 33588751 BACKGROUND

• Song T, Wu LJ, Li L. Comparison of combined intravenous and inhalation anesthesia and total intravenous anesthesia in laparoscopic surgery and the identification of predictive factors influencing the delayed recovery of neurocognitive function. Front Med (Lausanne). 2024 Mar 25;11:1353502. doi: 10.3389/fmed.2024.1353502. eCollection 2024.

  PMID: 38590312 BACKGROUND

• Wang Y, Cao M, Cao G, Liu Y, Zhang Y. Effect of combined intravenous-inhalation anesthesia on postoperative cognitive dysfunction after laparoscopic radical resection of cervical cancer: A protocol for systematic review and meta-analysis. Medicine (Baltimore). 2020 Nov 6;99(45):e23124. doi: 10.1097/MD.0000000000023124.

  PMID: 33157991 BACKGROUND

MeSH Terms

Interventions

Desflurane

Intervention Hierarchy (Ancestors)

Ethyl Ethers; Ethers; Organic Chemicals; Methyl Ethers; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons

Study Officials

• Ahmet YUKSEK, Md

  Kocaeli City Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmet YUKSEK, MD

CONTACT

05326580351; mdayuksek@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: July 28, 2025
• First Posted: August 14, 2025
• Study Start: July 23, 2025
• Primary Completion: October 29, 2025
• Study Completion: November 15, 2025
• Last Updated: August 14, 2025

Record last verified: 2025-08

Locations

TU (1)