ERAS Anesthetic Care for Metastatic Spine Cancer Resection

NCT05427825 | Unknown

• 1 other identifier: 202203092MINA
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Metastatic Bone Tumor

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Delirium incidence

  3 days

• Pain intensity

  3 days

Study Arms (2)

ERAS group

EXPERIMENTAL

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

Control

ACTIVE COMPARATOR

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

Other: Standard anesthetic care

Interventions

ERAS anesthetic care OTHER

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

ERAS group

Standard anesthetic care OTHER

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

Control

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing metastatic spine cancer resection surgery

You may not qualify if:

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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

RECRUITING

MeSH Terms

Conditions

Bone Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Chun-Yu Wu

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chun-Yu Wu

CONTACT

+886-9-72653376; b001089018@tmu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: June 16, 2022
• First Posted: June 22, 2022
• Study Start: July 1, 2022
• Primary Completion: December 1, 2023
• Study Completion: January 1, 2024
• Last Updated: June 28, 2022

Record last verified: 2022-06

Locations

TW (1)