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Multimodal GA for Lumbar Spine Surgery

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ClinicalTrials.gov Identifier: NCT05247177
Recruitment Status : Recruiting
First Posted : February 18, 2022
Last Update Posted : February 18, 2022
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

Tracking Information
First Submitted Date  ICMJE February 6, 2022
First Posted Date  ICMJE February 18, 2022
Last Update Posted Date February 18, 2022
Estimated Study Start Date  ICMJE February 2022
Estimated Primary Completion Date December 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 15, 2022)
Postoperative Quality of Recovery Score [ Time Frame: Change from Baseline QoR-15 to 24 hour and 74 hour after surgery ]
Postoperative Quality of Recovery Score assessed by using the QoR-15 system
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: February 15, 2022)
  • Postoperative delirium [ Time Frame: 3 days ]
    Postoperative delirium assessed by using the confusion assessment method (CAM) daily at least once for 3 days
  • Postoperative neurocognitive disorder [ Time Frame: 6 months ]
    Postoperative neurocognitive disorder assessed by using the Taiwanese Quick Mild Cognitive Impairment (Qmci-TW) test at 24 hours, 72 hours, 3-month and 6-month after surgery
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Multimodal GA for Lumbar Spine Surgery
Official Title  ICMJE Effects of Multimodal General Anesthesia for Older Patients Undergoing Lumbar Spine Fusion Surgery: a Randomized Controlled Trial
Brief Summary To evaluate the effects of multimodal general anesthesia on the recovery profile of elder patients undergoing lumbar spine fusion surgery.
Detailed Description Multimodal general anesthesia has been proposed in recent years. By administration of multiple agents acting on a different component of the nociceptive pathways, the multimodal general anesthesia may elicit maximal anesthetic effects with minimal anesthetic dose. These may be beneficial to improve postoperative recovery and reduce adverse effects such as postoperative delirium and perioperative neurocognitive impairment. It is not uncommon that elder patients undergoing lumbar spine fusion surgery suffer from postoperative poor recovery, postoperative delirium as well as the postoperative neurocognitive disorder. Therefore, this study aims to explore the potential effects of multimodal general anesthesia, which comprised with electroencephalography density spectrum array guided co-administration of sevoflurane, ketamine and dexmedetomidine, on the postoperative recovery profiles for elder patients undergoing lumbar spine fusion surgery.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Lumbar Spine Fusion Surgery
Intervention  ICMJE
  • Drug: dexmedetomidine, ketamine co-administration with sevoflurane for general anesthesia
    co-administration of sevoflurane, iv. dexmedetomidine and iv. ketamine to maintain a predefined EEG density spectrum array pattern for general anesthesia
  • Drug: Conventional general anesthesia by administration of sevoflurane alone
    Administration of sevoflurane alone to maintain anesthesia with a bispectral index between 40-60
Study Arms  ICMJE
  • Experimental: Multimodal general anesthesia
    General anesthesia maintained by co-administration of sevoflurane, dexmedetomidine and ketamine by using a predefined EEG density spectrum array pattern
    Intervention: Drug: dexmedetomidine, ketamine co-administration with sevoflurane for general anesthesia
  • Active Comparator: Conventional general anesthesia
    General anesthesia maintained by administration of sevoflurane alone to keep a bispectral index between 40-60
    Intervention: Drug: Conventional general anesthesia by administration of sevoflurane alone
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 15, 2022)
160
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2023
Estimated Primary Completion Date December 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria:

1. patients with ages at least 60-year undergoing elective lumbar spine surgery

Exclusion:

  1. A history of dementia
  2. Impaired liver function, eg. AST or ALT >100; liver cirrhosis > Child B class
  3. Impaired renal function, cGFR< 60 ml/min/1.73 m2
  4. Cardiac dysfunction, such as heart failure > NYHA class II
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Chun-Yu Wu 0972653376 longersolo@gmail.com
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05247177
Other Study ID Numbers  ICMJE 202112040MIND
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party National Taiwan University Hospital
Original Responsible Party Same as current
Current Study Sponsor  ICMJE National Taiwan University Hospital
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Chun-Yu Wu, MD National Taiwan University Hospital
PRS Account National Taiwan University Hospital
Verification Date February 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP