ERAS Anesthetic Care for Metastatic Spine Cancer Resection

Not Applicable

• Conditions: Metastatic Bone Tumor
• Interventions: Other: ERAS anesthetic care; Other: Standard anesthetic care

• Registration Number: NCT05427825
• Lead Sponsor: National Taiwan University Hospital

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2022-06
• Study First Submitted: 2022-06-16
• Study First Submitted QC: 2022-06-16
• Study First Posted: 2022-06-22
• Last Update Submitted: 2022-06-22
• Last Update Posted: 2022-06-28
• Study Start: 2022-07
• Primary Completion: 2023-12
• Study Completion: 2024-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Patients undergoing metastatic spine cancer resection surgery

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Exclusion Criteria

• Expected survival less than 6 months
• Previous surgery or radiotherapy for the spine metastasis

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
ERAS group	ERAS anesthetic care	Patients in the experimental group receive the protocolized anesthetic care bundle including EEG spectrum-guided multimodal anesthesia and HPI-guided hemodynamic therapy.
Control	Standard anesthetic care	Patients in the control group receive standard anesthetic care including bispetral index-guided balanced anesthesia and regular hemodynamic care protocols.

Primary Outcome Measures

Name	Time	Method
Postoperative quality of recovery-15 score (QoR-15)	3 days	Comparing the quality of recovery-15 score (0-150) at the first and third postoperative days

Secondary Outcome Measures

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

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan