Multimodal GA for Lumbar Spine Surgery

Study Overview
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Brief Summary
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To evaluate the effects of multimodal general anesthesia on the recovery profile of elder patients undergoing lumbar spine fusion surgery.

Detailed Description
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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.

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

Conditions
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Lumbar Spine Fusion Surgery

Intervention / Treatment
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* Drug: dexmedetomidine, ketamine co-administration with sevoflurane for general anesthesia
* Drug: Conventional general anesthesia by administration of sevoflurane alone


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: 1. patients with ages at least 60-year undergoing elective lumbar spine surgery Exclusion: 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

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Multimodal general anesthesia<br>General anesthesia maintained by co-administration of sevoflurane, dexmedetomidine and ketamine by using a predefined EEG density spectrum array pattern | Drug: dexmedetomidine, ketamine co-administration with sevoflurane for general anesthesia<br>* co-administration of sevoflurane, iv. dexmedetomidine and iv. ketamine to maintain a predefined EEG density spectrum array pattern for general anesthesia<br>|
| Active Comparator: Conventional general anesthesia<br>General anesthesia maintained by administration of sevoflurane alone to keep a bispectral index between 40-60 | Drug: Conventional general anesthesia by administration of sevoflurane alone<br>* Administration of sevoflurane alone to maintain anesthesia with a bispectral index between 40-60<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative Quality of Recovery Score | Postoperative Quality of Recovery Score assessed by using the QoR-15 system | Change from Baseline QoR-15 to 24 hour and 74 hour after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative delirium | Postoperative delirium assessed by using the confusion assessment method (CAM) daily at least once for 3 days | 3 days | 
| Postoperative neurocognitive disorder | Postoperative neurocognitive disorder assessed by using the Taiwanese Quick Mild Cognitive Impairment (Qmci-TW) test at 24 hours, 72 hours, 3-month and 6-month after surgery | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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multimodal general anesthesia,lumbar spine surgery,electroencephalographic,EEG,density spectrum array,DSA,bispectral index(BIS)