Multimodal GA for Lumbar Spine Surgery

Effects of Multimodal General Anesthesia for Older Patients Undergoing Lumbar Spine Fusion Surgery: a Randomized Controlled Trial

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05247177

Enrollment

100

Registered

2022-02-18

Start date

2022-03-14

Completion date

2025-09-02

Last updated

2025-10-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lumbar Spine Fusion Surgery

Keywords

multimodal general anesthesia,lumbar spine surgery,electroencephalographic,EEG,density spectrum array,DSA,bispectral index(BIS)

Brief summary

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.

Interventions

DRUGdexmedetomidine, ketamine co-administration with sevoflurane for general anesthesia

co-administration of sevoflurane, iv. dexmedetomidine and iv. ketamine to maintain a predefined EEG density spectrum array pattern for general anesthesia

DRUGConventional general anesthesia by administration of sevoflurane alone

Administration of sevoflurane alone to maintain anesthesia with a bispectral index between 40-60

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

60 Years to 90 Years

Healthy volunteers

Inclusion criteria

1\. patients with ages at least 60-year undergoing elective lumbar spine surgery Exclusion: 1. A history of dementia 2. Impaired liver function, eg. AST or ALT \>100; liver cirrhosis \> Child B class 3. Impaired renal function, cGFR\< 60 ml/min/1.73 m2 4. Cardiac dysfunction, such as heart failure \> NYHA class II

Design outcomes

Primary

Measure	Time frame	Description
Postoperative Quality of Recovery Score	Change from Baseline QoR-15 to 24 hour after surgery	Postoperative Quality of Recovery Score assessed by using the QoR-15 system

Secondary

Measure	Time frame	Description
Postoperative delirium	3 days	Postoperative delirium assessed by using the confusion assessment method (CAM) daily at least once for 3 days
Postoperative chronic pain	3 months	Postoperative chronic pain intensity at 3 months after surgery assessed by using the Brief Pain Inventory questionnaire.

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026