Multimodal GA for Lumbar Spine Surgery

Effects of Multimodal General Anesthesia for Older Patients Undergoing Lumbar Spine Fusion Surgery: a Randomized Controlled Trial

To evaluate the effects of multimodal general anesthesia on the recovery profile of elder patients undergoing lumbar spine fusion surgery.

Study Overview

• Status: Completed
• Conditions: Lumbar Spine Fusion Surgery
• Intervention / Treatment: Drug: dexmedetomidine, ketamine co-administration with sevoflurane for general anesthesia; Drug: Conventional general anesthesia by administration of sevoflurane alone

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
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan
    • National Taiwan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 56 years to 86 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Multimodal general anesthesia; General anesthesia maintained by co-administration of sevoflurane, dexmedetomidine and ketamine by using a predefined EEG density spectrum array pattern	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
Active Comparator: Conventional general anesthesia; General anesthesia maintained by administration of sevoflurane alone to keep a bispectral index between 40-60	Drug: Conventional general anesthesia by administration of sevoflurane alone; Administration of sevoflurane alone to maintain anesthesia with a bispectral index between 40-60

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative Quality of Recovery Score	Postoperative Quality of Recovery Score assessed by using the QoR-15 system	Change from Baseline QoR-15 to 24 hour after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative delirium	Postoperative delirium assessed by using the confusion assessment method (CAM) daily at least once for 3 days	3 days
Postoperative chronic pain	Postoperative chronic pain intensity at 3 months after surgery assessed by using the Brief Pain Inventory questionnaire.	3 months

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): March 14, 2022
• Primary Completion (Actual): June 3, 2025
• Study Completion (Actual): September 2, 2025

Study Registration Dates

• First Submitted: February 6, 2022
• First Submitted That Met QC Criteria: February 15, 2022
• First Posted (Actual): February 18, 2022

Study Record Updates

• Last Update Posted (Estimated): October 3, 2025
• Last Update Submitted That Met QC Criteria: September 29, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: multimodal general anesthesia,lumbar spine surgery,electroencephalographic,EEG,density spectrum array,DSA,bispectral index(BIS)
• Additional Relevant MeSH Terms: Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Ethers; Azoles; Hydrocarbons; Imidazoles; Hydrocarbons, Halogenated; Anesthesia and Analgesia; Hydrocarbons, Fluorinated; Anesthesia; Methyl Ethers; Sevoflurane; Dexmedetomidine; Anesthesia, General
• Other Study ID Numbers: 202112040MIND

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No