ERAS Anesthetic Care for Metastatic Spine Cancer Resection

Study Overview
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Brief Summary
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Spinal metastases account for 60% of all malignant bone metastases and represent a medically important treatment goal. For patients with malignant tumors diagnosed at this stage, performing En bloc spondylectomy with wide margin of resection facilitate the improvement in quality of life including ambulatory ability, daily activities independence and attenuation of bone pain. However, En bloc spondylectomy is a major operation with long operation time and frequent hemodynamic instability during the operation. Therefore, the anesthetic care plays an important role and an enhanced recovery after surgery (ERAS) is the goal. For the ERAS anesthesia protocol for En bloc spondylectomy, we propose two major components to achieve this goal: (1) an encephalographic spectrum guided multimodal anesthesia combined with ultrasound-guided nerve block and (2) the advanced machine-learning algorithm index, namely the hypotension predictive index (HPI) guided hemodynamic protocol.

Detailed Description
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The anesthetic protocol comprises of two major proposed components to enhanced recovery after spine cancer total en bloc resection. First, a multimodal general anesthesia consisting of GABAnergic hypnotic agent (propofol or sevoflurane), ketamine and dexmedetomidine was conducted by using the encephalographic density spectrum array. In addition, ultrasound-guided erector spinae plane block is applied. These techniques potentially prevent anesthesia induced delirium and may profoundly improve postoperative analgesic quality. Second, advanced hemodynamic monitoring device, namely the hypotensio predictive index, will be used for prevention of intraoperative hypotension and facilitate precise transfusion protocol.

Official Title
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Anesthetic Protocols for Enhance Recovery After Metastatic Spine Tumor Resection Surgery: a Randomized Controlled Trial

Conditions
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Metastatic Bone Tumor

Intervention / Treatment
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* Other: ERAS anesthetic care
* Other: Standard anesthetic care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing metastatic spine cancer resection surgery Exclusion Criteria: Expected survival less than 6 months Previous surgery or radiotherapy for the spine metastasis

Ages Eligible for Study
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Minimum Age: 20 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: Factorial Assignment
Interventional Model Description: Patients in the treatment group received the study protocolized care bundle including multimodal anesthesia and HPI-assisted hemodynamic therapy.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ERAS group<br>Patients in the experimental group receive the protocolized anesthetic care bundle including EEG spectrum-guided multimodal anesthesia and HPI-guided hemodynamic therapy. | Other: ERAS anesthetic care<br>* The ERAS anesthetic care includes EEG spectrum-guided multimodal anesthesia and HPI-guided hemodynamic therapy.<br>|
| Active Comparator: Control<br>Patients in the control group receive standard anesthetic care including bispetral index-guided balanced anesthesia and regular hemodynamic care protocols. | Other: Standard anesthetic care<br>* The standard anesthetic care includes bispectral index guided general anesthesia and arterial line monitored hemodynamic care.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative quality of recovery-15 score (QoR-15) | Comparing the quality of recovery-15 score (0-150) at the first and third postoperative days | 3 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Delirium incidence | Delirium diagnosed based on the Confusion Assessment Method (CAM) criteria during three days after surgery | 3 days | 
| Pain intensity | Postoperative pain intensity measure by using the visual analogue scale (0-10) | 3 days |