Multimodal GA for Lumbar Spine Surgery

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

Tracking Information

• First Submitted Date: February 6, 2022
• First Posted Date: February 18, 2022
• Last Update Posted Date: February 18, 2022
• Estimated Study Start Date: February 2022
• Estimated Primary Completion Date: December 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Multimodal GA for Lumbar Spine Surgery
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Lumbar Spine Fusion Surgery

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: February 15, 2022): 160
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 2023
• Estimated Primary Completion Date: December 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 60 Years to 90 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Chun-Yu Wu; 0972653376; longersolo@gmail.com

• Listed Location Countries: Taiwan

Administrative Information

• NCT Number: NCT05247177
• Other Study ID Numbers: 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: Not Provided
• Current Responsible Party: National Taiwan University Hospital
• Original Responsible Party: Same as current
• Current Study Sponsor: National Taiwan University Hospital
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Chun-Yu Wu, MD; National Taiwan University Hospital

• PRS Account: National Taiwan University Hospital
• Verification Date: February 2022