ERAS Anesthetic Care for Metastatic Spine Cancer Resection

NCT ID: NCT05427825

Last Updated: 2022-06-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-31
• Study Completion Date: 2024-01-31

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.

Conditions

Metastatic Bone Tumor

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

ERAS group

Patients in the experimental group receive the protocolized anesthetic care bundle including EEG spectrum-guided multimodal anesthesia and HPI-guided hemodynamic therapy.

Group Type: EXPERIMENTAL

ERAS anesthetic care

Intervention Type: OTHER

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

Control

Patients in the control group receive standard anesthetic care including bispetral index-guided balanced anesthesia and regular hemodynamic care protocols.

Group Type: ACTIVE_COMPARATOR

Standard anesthetic care

Intervention Type: OTHER

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

Interventions

ERAS anesthetic care

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

Intervention Type: OTHER

Standard anesthetic care

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chun-Yu Wu

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital

Locations

National Taiwan University Hospital

Taipei, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Chun-Yu Wu

Role: CONTACT

b001089018@tmu.edu.tw

+886-9-72653376

Facility Contacts

Chun-Yu Wu

Role: primary

886-9-72653376

Other Identifiers

202203092MINA

Identifier Type: -

Identifier Source: org_study_id