Postoperative RecoveryPhase 4NCT07123870
Effect of Combined Intravenous-Inhalational Anesthesia (CIVIA) on Postoperative Recovery Patterns.
A Phase 4 study testing Sevofluorane, Desflurane and Total Intravenous Anesthesia(TIVA) in people with Postoperative Recovery and Inhalation Anesthesia, run by Kocaeli City Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Postoperative Recovery, Inhalation Anesthesia, Total Intravenous Anesthesia
- What is being tested?
- Sevofluorane, Desflurane and Total Intravenous Anesthesia(TIVA)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 23 Jul 2025to 15 Nov 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- Sevofluorane, Desflurane, Total Intravenous Anesthesia(TIVA)
- Keywords
- CIVIA, TIVA, sevoflurane, desflurane, postoperative recovery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SevofluoraneDrug
Also called Sevoflurane Combined Anesthesia
In this group of patients, <0.5 MAC sevoflurane will be used in combination with TIVA. (TIVA method described above)
DesfluraneDrug
Also called Desflurane Combined anesthesia
In this group of patients, <0.5 MAC Desflurane will be used in combination with TIVA.
Total Intravenous Anesthesia(TIVA)Drug
Also called Total Intravenous Anesthesia
In this group, TIVA will be applied with the combination of BIS-guided propofol + remifentanil.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: 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. Receives: Drug: Total Intravenous Anesthesia(TIVA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Extubation time
Extubation time in patients after all anesthetic drugs have been discontinued
Measured: First postoperative hour
Secondary outcomes (1)
Eye opening
time brtween anesthesia terminated and aye opening after surgery
Measured: First postoperative hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2025
- Study start23 Jul 2025
- Primary completion12 Nov 2025
- Study completion15 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Postoperative RecoveryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kocaeli City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ahmet Yuksek, Kocaeli City Hospital
- Investigators
- Ahmet YUKSEK, Md, Principal investigator, Kocaeli City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07123870
- Sponsor's protocol ID
- KAEK/10.bI.02
- Status last verified
- Oct 2026
- First submitted
- 28 Jul 2025
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 33588751Wang 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.
PubMed 33157991Song 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.
PubMed 38590312
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Combined Intravenous-Inhalational Anesthesia (CIVIA) on Postoperative Recovery Patterns.
- ClinicalTrials.gov ID
- NCT07123870
- Acronym / sponsor ID
- KAEK/10.bI.02
- Keywords
- CIVIA, TIVA, sevoflurane, desflurane, postoperative recovery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Kocaeli City HospitalOther government
- Study start
- 23 Jul 2025 (actual)
- Primary completion
- 12 Nov 2025 (actual)
- Study completion
- 15 Nov 2025 (actual)
- First posted
- 14 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sevoflurane combined with TIVA | Experimental | Drug: SevofluoraneCombined 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. |
| Desflurane combined with TIVA | Experimental | Drug: DesfluraneCombined 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 |
| TIVA | Experimental | Drug: Total Intravenous Anesthesia(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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SevofluoraneAlso: Sevoflurane Combined AnesthesiaIn this group of patients, <0.5 MAC sevoflurane will be used in combination with TIVA. (TIVA method described above) | Drug | Sevoflurane combined with TIVA |
| DesfluraneAlso: Desflurane Combined anesthesiaIn this group of patients, <0.5 MAC Desflurane will be used in combination with TIVA. | Drug | Desflurane combined with TIVA |
| Total Intravenous Anesthesia(TIVA)Also: Total Intravenous AnesthesiaIn this group, TIVA will be applied with the combination of BIS-guided propofol + remifentanil. | Drug | TIVA |
Primary outcome
Extubation time
Time frame: First postoperative hour
Extubation time in patients after all anesthetic drugs have been discontinued
1 secondary outcome
Eye opening
Time frame: First postoperative hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Background: PubMed 33588751Wolf 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.
- Background: PubMed 33157991Wang 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.
- Results publication: PubMed 38590312Song 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmet YUKSEK, Md principal investigator
Kocaeli City Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sevofluorane, Desflurane and Total Intravenous Anesthesia(TIVA) in people with Postoperative Recovery and Inhalation Anesthesia, run by Kocaeli City Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Extubation time (time frame: First postoperative hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07123870, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.