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ERAS Anesthetic Care for Metastatic Spine Cancer Resection

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05427825
Enrollment
120
Registered
2022-06-22
Start date
2022-07-31
Completion date
2024-01-31
Last updated
2022-06-28

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

Conditions

Metastatic Bone Tumor

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.

Interventions

OTHERERAS anesthetic care

The ERAS anesthetic care includes EEG spectrum-guided multimodal anesthesia and HPI-guided hemodynamic therapy.

OTHERStandard anesthetic care

The standard anesthetic care includes bispectral index guided general anesthesia and arterial line monitored hemodynamic care.

Sponsors

National Taiwan University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Intervention model description

Patients in the treatment group received the study protocolized care bundle including multimodal anesthesia and HPI-assisted hemodynamic therapy.

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Postoperative quality of recovery-15 score (QoR-15)3 daysComparing the quality of recovery-15 score (0-150) at the first and third postoperative days

Secondary

MeasureTime frameDescription
Delirium incidence3 daysDelirium diagnosed based on the Confusion Assessment Method (CAM) criteria during three days after surgery
Pain intensity3 daysPostoperative pain intensity measure by using the visual analogue scale (0-10)

Countries

Taiwan

Contacts

Primary ContactChun-Yu Wu
b001089018@tmu.edu.tw+886-9-72653376

Outcome results

None listed

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