Lumbar Spine Fusion SurgeryNCT05247177
Multimodal GA for Lumbar Spine Surgery
A study testing dexmedetomidine, ketamine co-administration with sevoflurane for general anesthesia and Conventional general anesthesia by administration of sevoflurane alone in people with Lumbar Spine Fusion Surgery, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
To evaluate the effects of multimodal general anesthesia on the recovery profile of elder patients undergoing lumbar spine fusion surgery. Read more about this study
- Who is it for?
- Ages 60 to 90 years
- Conditions the study is for
- Lumbar Spine Fusion Surgery
- What is being tested?
- dexmedetomidine, ketamine co-administration with sevoflurane for general anesthesia and Conventional general anesthesia by administration of sevoflurane alone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- 14 Mar 2022to 2 Sep 2025
- Phase
- Interventional
- 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 60 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. patients with ages at least 60-year undergoing elective lumbar spine surgery
Who cannot join
- A history of dementia
- Impaired liver function, eg. AST or ALT >100; liver cirrhosis > Child B class
- Impaired renal function, cGFR< 60 ml/min/1.73 m2
- Cardiac dysfunction, such as heart failure > NYHA class II
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Multimodal General Anesthesia for Older Patients Undergoing Lumbar Spine Fusion Surgery: a Randomized Controlled Trial
To evaluate the effects of multimodal general anesthesia on the recovery profile of elder patients undergoing lumbar spine fusion surgery.
Read the detailed description
Multimodal general anesthesia has been proposed in recent years. By administration of multiple agents acting on a different component of the nociceptive pathways, the multimodal general anesthesia may elicit maximal anesthetic effects with minimal anesthetic dose. These may be beneficial to improve postoperative recovery and reduce adverse effects such as postoperative delirium and perioperative neurocognitive impairment. It is not uncommon that elder patients undergoing lumbar spine fusion surgery suffer from postoperative poor recovery, postoperative delirium as well as the postoperative neurocognitive disorder. Therefore, this study aims to explore the potential effects of multimodal general anesthesia, which comprised with electroencephalography density spectrum array guided co-administration of sevoflurane, ketamine and dexmedetomidine, on the postoperative recovery profiles for elder patients undergoing lumbar spine fusion surgery.
- Conditions
- Lumbar Spine Fusion Surgery
- Being tested
- dexmedetomidine, ketamine co-administration with sevoflurane for general anesthesia, Conventional general anesthesia by administration of sevoflurane alone
- Keywords
- multimodal general anesthesia,lumbar spine surgery,electroencephalographic,EEG,density spectrum array,DSA,bispectral index(BIS)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dexmedetomidine, ketamine co-administration with sevoflurane for general anesthesiaDrug
co-administration of sevoflurane, iv. dexmedetomidine and iv. ketamine to maintain a predefined EEG density spectrum array pattern for general anesthesia
Conventional general anesthesia by administration of sevoflurane aloneDrug
Administration of sevoflurane alone to maintain anesthesia with a bispectral index between 40-60
| Study group | Role | What they receive |
|---|---|---|
| Multimodal general anesthesia | Experimental | General anesthesia maintained by co-administration of sevoflurane, dexmedetomidine and ketamine by using a predefined EEG density spectrum array pattern Receives: Drug: dexmedetomidine, ketamine co-administration with sevoflurane for general anesthesia |
| Conventional general anesthesia | Active comparator | General anesthesia maintained by administration of sevoflurane alone to keep a bispectral index between 40-60 Receives: Drug: Conventional general anesthesia by administration of sevoflurane alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Quality of Recovery Score
Postoperative Quality of Recovery Score assessed by using the QoR-15 system
Measured: Change from Baseline QoR-15 to 24 hour after surgery
Secondary outcomes (2)
Postoperative delirium
Postoperative delirium assessed by using the confusion assessment method (CAM) daily at least once for 3 days
Measured: 3 days
Postoperative chronic pain
Postoperative chronic pain intensity at 3 months after surgery assessed by using the Brief Pain Inventory questionnaire.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2022
- Study start14 Mar 2022
- Primary completion3 Jun 2025
- Study completion2 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lumbar Spine Fusion SurgeryStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chun-Yu Wu, MD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05247177
- Sponsor's protocol ID
- 202112040MIND
- Status last verified
- Sep 2025
- First submitted
- 6 Feb 2022
- Last updated
- 3 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Tsuang FY, Shih PY, Lin CP, Cheng HL, Lin SH, Wu CY. Dexmedetomidine-Ketamine-Based Multimodal General Anesthesia with Electroencephalographic Spectrogram-Guided Titration Improves Early Recovery After Lumbar Spine Fusion in Older Adults: A Randomized Controlled Trial. Drug Des Devel Ther. 2026 Aug 18;20:627450. doi: 10.2147/DDDT.S627450. eCollection 2026.
PubMed 42633440
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Multimodal General Anesthesia for Older Patients Undergoing Lumbar Spine Fusion Surgery: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05247177
- Acronym / sponsor ID
- 202112040MIND
- Conditions
- Lumbar Spine Fusion Surgery
- Keywords
- multimodal general anesthesia,lumbar spine surgery,electroencephalographic,EEG,density spectrum array,DSA,bispectral index(BIS)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 14 Mar 2022 (actual)
- Primary completion
- 3 Jun 2025 (actual)
- Study completion
- 2 Sep 2025 (actual)
- First posted
- 18 Feb 2022 (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.
To evaluate the effects of multimodal general anesthesia on the recovery profile of elder patients undergoing lumbar spine fusion surgery.
Detailed description
Multimodal general anesthesia has been proposed in recent years. By administration of multiple agents acting on a different component of the nociceptive pathways, the multimodal general anesthesia may elicit maximal anesthetic effects with minimal anesthetic dose. These may be beneficial to improve postoperative recovery and reduce adverse effects such as postoperative delirium and perioperative neurocognitive impairment. It is not uncommon that elder patients undergoing lumbar spine fusion surgery suffer from postoperative poor recovery, postoperative delirium as well as the postoperative neurocognitive disorder. Therefore, this study aims to explore the potential effects of multimodal general anesthesia, which comprised with electroencephalography density spectrum array guided co-administration of sevoflurane, ketamine and dexmedetomidine, on the postoperative recovery profiles for elder patients undergoing lumbar spine fusion surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multimodal general anesthesia | Experimental | Drug: dexmedetomidine, ketamine co-administration with sevoflurane for general anesthesiaGeneral anesthesia maintained by co-administration of sevoflurane, dexmedetomidine and ketamine by using a predefined EEG density spectrum array pattern |
| Conventional general anesthesia | Active comparator | Drug: Conventional general anesthesia by administration of sevoflurane aloneGeneral anesthesia maintained by administration of sevoflurane alone to keep a bispectral index between 40-60 |
Who may qualify
- Ages
- 60 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. patients with ages at least 60-year undergoing elective lumbar spine surgery
Key exclusion criteria (4 listed)
- A history of dementia
- Impaired liver function, eg. AST or ALT >100; liver cirrhosis > Child B class
- Impaired renal function, cGFR< 60 ml/min/1.73 m2
- Cardiac dysfunction, such as heart failure > NYHA class II
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 |
|---|---|---|
| dexmedetomidine, ketamine co-administration with sevoflurane for general anesthesiaco-administration of sevoflurane, iv. dexmedetomidine and iv. ketamine to maintain a predefined EEG density spectrum array pattern for general anesthesia | Drug | Multimodal general anesthesia |
| Conventional general anesthesia by administration of sevoflurane aloneAdministration of sevoflurane alone to maintain anesthesia with a bispectral index between 40-60 | Drug | Conventional general anesthesia |
Primary outcome
Postoperative Quality of Recovery Score
Time frame: Change from Baseline QoR-15 to 24 hour after surgery
Postoperative Quality of Recovery Score assessed by using the QoR-15 system
2 secondary outcomes
Postoperative delirium
Time frame: 3 days
Postoperative chronic pain
Time frame: 3 months
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 3 Oct 2025.
- Derived from this study: PubMed 42633440Tsuang FY, Shih PY, Lin CP, Cheng HL, Lin SH, Wu CY. Dexmedetomidine-Ketamine-Based Multimodal General Anesthesia with Electroencephalographic Spectrogram-Guided Titration Improves Early Recovery After Lumbar Spine Fusion in Older Adults: A Randomized Controlled Trial. Drug Des Devel Ther. 2026 Aug 18;20:627450. doi: 10.2147/DDDT.S627450. eCollection 2026.
Related trials for Lumbar Spine Fusion Surgery
Not yet recruiting
TLIP Block Versus Retrolaminar Block on Quality of Recovery After Posterior Lumbar Spine Fusion Surgery
Postoperative Pain, Spinal Fusion Surgery
RecruitingPhase 4
Efficacy and Safety of Preemptive Intravenous Dexamethasone in MIS-TLIF
Spinal Stenosis Lumbar, Disc Degeneration
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.
Chun-Yu Wu, MD principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dexmedetomidine, ketamine co-administration with sevoflurane for general anesthesia and Conventional general anesthesia by administration of sevoflurane alone in people with Lumbar Spine Fusion Surgery, run by National Taiwan University Hospital at 1 site in Taiwan.
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 1 inclusion and 4 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 3 Oct 2025. 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 Taiwan. 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.
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?
Postoperative Quality of Recovery Score (time frame: Change from Baseline QoR-15 to 24 hour after surgery). 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 NCT05247177, which also lists 1 linked publication.
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 3 Oct 2025; AzTrials last refreshed its copy on 30 Oct 2026.