Multimodal GA for Lumbar Spine Surgery

NCT ID: NCT05247177

Last Updated: 2025-10-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-14
• Study Completion Date: 2025-09-02

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.

Conditions

Lumbar Spine Fusion Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Multimodal general anesthesia

General anesthesia maintained by co-administration of sevoflurane, dexmedetomidine and ketamine by using a predefined EEG density spectrum array pattern

Group Type: EXPERIMENTAL

dexmedetomidine, ketamine co-administration with sevoflurane for general anesthesia

Intervention Type: DRUG

co-administration of sevoflurane, iv. dexmedetomidine and iv. ketamine to maintain a predefined EEG density spectrum array pattern for general anesthesia

Conventional general anesthesia

General anesthesia maintained by administration of sevoflurane alone to keep a bispectral index between 40-60

Group Type: ACTIVE_COMPARATOR

Conventional general anesthesia by administration of sevoflurane alone

Intervention Type: DRUG

Administration of sevoflurane alone to maintain anesthesia with a bispectral index between 40-60

Interventions

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

Intervention Type: DRUG

Conventional general anesthesia by administration of sevoflurane alone

Administration of sevoflurane alone to maintain anesthesia with a bispectral index between 40-60

Intervention Type: DRUG

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

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chun-Yu Wu, MD

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital

Locations

National Taiwan University Hospital

Taipei, , Taiwan

Countries

Taiwan

Other Identifiers

202112040MIND

Identifier Type: -

Identifier Source: org_study_id