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NCT Number: NCT07123870

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Kocaeli City Hospital

Kocaeli, Izmıt, Yozgat, Turkey (Türkiye)

Location status: Recruiting

Location contact

Ahmet YUKSEK, Md

CONTACT

[email protected]

05326580351

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Sevofluorane

Drug

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

Other names: Sevoflurane Combined Anesthesia

Desflurane

Drug

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

Other names: Desflurane Combined anesthesia

Total Intravenous Anesthesia(TIVA)

Drug

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

Other names: Total Intravenous Anesthesia

Primary outcomes

  1. Extubation time

    Time frame: First postoperative hour

    Extubation time in patients after all anesthetic drugs have been discontinued

Secondary outcomes

  1. Eye opening

    Time frame: First postoperative hour

    time brtween anesthesia terminated and aye opening after surgery

Other outcomes

  1. Richmond Agitation-Sedation Scale (RASS)

    Time frame: first 2 hours postoperatively

    Richmond Agitation-Sedation Scale (RASS) A 10-point scale ranging from +4 (combative) to -5 (unarousable). Measures agitation, sedation level, and responsiveness. Helps guide sedation management and assess recovery from anesthesia.

  2. Postoperative Nausia and Vomiting

    Time frame: First 2 postoperative hours

    Postoperative Nausia and Vomitting incidance

  3. PACU discharge time

    Time frame: First 2 postoperative hours

    The time between the termination of anesthesia and the patient being discharged from the postoperative recovery room (PACU) with an Aldrete score of >9. It is calculated in minutes.

Study contacts

Contact information is provided by the study sponsor or research team.

Ahmet YUKSEK, MD

CONTACT

[email protected]

05326580351

Sponsors and collaborators

Lead sponsor

Kocaeli City Hospital

Other Gov

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Aug 14, 2025
Registry last updated
Aug 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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