ERAS Anesthetic Care for Metastatic Spine Cancer Resection
Primary Purpose
Metastatic Bone Tumor
Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
ERAS anesthetic care
Standard anesthetic care
Sponsored by
About this trial
This is an interventional treatment trial for Metastatic Bone Tumor
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
Sites / Locations
- National Taiwan University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
ERAS group
Control
Arm Description
Patients in the experimental group receive the protocolized anesthetic care bundle including EEG spectrum-guided multimodal anesthesia and HPI-guided hemodynamic therapy.
Patients in the control group receive standard anesthetic care including bispetral index-guided balanced anesthesia and regular hemodynamic care protocols.
Outcomes
Primary Outcome Measures
Postoperative quality of recovery-15 score (QoR-15)
Comparing the quality of recovery-15 score (0-150) at the first and third postoperative days
Secondary Outcome Measures
Delirium incidence
Delirium diagnosed based on the Confusion Assessment Method (CAM) criteria during three days after surgery
Pain intensity
Postoperative pain intensity measure by using the visual analogue scale (0-10)
Full Information
NCT ID
NCT05427825
First Posted
June 16, 2022
Last Updated
June 22, 2022
Sponsor
National Taiwan University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05427825
Brief Title
ERAS Anesthetic Care for Metastatic Spine Cancer Resection
Official Title
Anesthetic Protocols for Enhance Recovery After Metastatic Spine Tumor Resection Surgery: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 2022 (Anticipated)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
January 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Bone Tumor
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
Patients in the treatment group received the study protocolized care bundle including multimodal anesthesia and HPI-assisted hemodynamic therapy.
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ERAS group
Arm Type
Experimental
Arm Description
Patients in the experimental group receive the protocolized anesthetic care bundle including EEG spectrum-guided multimodal anesthesia and HPI-guided hemodynamic therapy.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Patients in the control group receive standard anesthetic care including bispetral index-guided balanced anesthesia and regular hemodynamic care protocols.
Intervention Type
Other
Intervention Name(s)
ERAS anesthetic care
Intervention Description
The ERAS anesthetic care includes EEG spectrum-guided multimodal anesthesia and HPI-guided hemodynamic therapy.
Intervention Type
Other
Intervention Name(s)
Standard anesthetic care
Intervention Description
The standard anesthetic care includes bispectral index guided general anesthesia and arterial line monitored hemodynamic care.
Primary Outcome Measure Information:
Title
Postoperative quality of recovery-15 score (QoR-15)
Description
Comparing the quality of recovery-15 score (0-150) at the first and third postoperative days
Time Frame
3 days
Secondary Outcome Measure Information:
Title
Delirium incidence
Description
Delirium diagnosed based on the Confusion Assessment Method (CAM) criteria during three days after surgery
Time Frame
3 days
Title
Pain intensity
Description
Postoperative pain intensity measure by using the visual analogue scale (0-10)
Time Frame
3 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chun-Yu Wu
Phone
+886-9-72653376
Email
b001089018@tmu.edu.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chun-Yu Wu
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chun-Yu Wu
Phone
886-9-72653376
12. IPD Sharing Statement
Learn more about this trial
ERAS Anesthetic Care for Metastatic Spine Cancer Resection
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