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.
Full Title of Study: “Anesthetic Protocols for Enhance Recovery After Metastatic Spine Tumor Resection Surgery: a Randomized Controlled Trial”
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Factorial Assignment
- Primary Purpose: Treatment
- Masking: Triple (Participant, Investigator, Outcomes Assessor)
- Study Primary Completion Date: December 2023
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.
- Other: ERAS anesthetic care
- The ERAS anesthetic care includes EEG spectrum-guided multimodal anesthesia and HPI-guided hemodynamic therapy.
- Other: Standard anesthetic care
- The standard anesthetic care includes bispectral index guided general anesthesia and arterial line monitored hemodynamic care.
Arms, Groups and Cohorts
- Experimental: ERAS group
- Patients in the experimental group receive the protocolized anesthetic care bundle including EEG spectrum-guided multimodal anesthesia and HPI-guided hemodynamic therapy.
- Active Comparator: Control
- Patients in the control group receive standard anesthetic care including bispetral index-guided balanced anesthesia and regular hemodynamic care protocols.
Clinical Trial Outcome Measures
- Postoperative quality of recovery score (QoR-15)
- Time Frame: 3 days
- Comparing the QoR-15 score at the first and third postoperative days
- Delirium incidence
- Time Frame: 3 days
- Delirium diagnosed based on the Confusion Assessment Method (CAM) criteria during three days after surgery
- Pain intensity
- Time Frame: 3 days
- Postoperative pain intensity measure by using the visual analogue scale
Participating in This Clinical Trial
- Patients undergoing metastatic spine cancer resection surgery Exclusion Criteria:
- Expected survival less than 6 months – Previous surgery or radiotherapy for the spine metastasis
Gender Eligibility: All
Minimum Age: 20 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- National Taiwan University Hospital
- Provider of Information About this Clinical Study
- Overall Official(s)
- Chun-Yu Wu, Principal Investigator, National Taiwan University Hospital
- Overall Contact(s)
- Chun-Yu Wu, +886-9-72653376, firstname.lastname@example.org
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