ERAS Anesthetic Care for Metastatic Spine Cancer Resection

Metastatic Bone Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05427825
• Other study ID #: 202203092MINA
• Status: Recruiting
• Phase: N/A
• Start date: July 2022
• Est. completion date: January 2024

Study information

• Verified date: June 2022
• Source: National Taiwan University Hospital
• Contact: Chun-Yu Wu
• Phone: +886-9-72653376
• Email: b001089018[@]tmu.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: January 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bone Neoplasms
• Metastatic Bone Tumor

Intervention

Other:
• ERAS anesthetic care
The ERAS anesthetic care includes EEG spectrum-guided multimodal anesthesia and HPI-guided hemodynamic therapy.
• Standard anesthetic care
The standard anesthetic care includes bispectral index guided general anesthesia and arterial line monitored hemodynamic care.

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Delirium incidence	Delirium diagnosed based on the Confusion Assessment Method (CAM) criteria during three days after surgery	3 days
Secondary	Pain intensity	Postoperative pain intensity measure by using the visual analogue scale (0-10)	3 days