Multimodal GA for Lumbar Spine Surgery

Not Applicable

Recruiting

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

• Registration Number: NCT05247177
• Lead Sponsor: National Taiwan University Hospital

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2022-02-06
• Study First Submitted QC: 2022-02-15
• Study First Posted: 2022-02-18
• Study Start: 2022-03-14
• Status Verified: 2024-05
• Last Update Submitted: 2024-06-17
• Last Update Posted: 2024-06-18
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

Not provided

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional general anesthesia	Conventional general anesthesia by administration of sevoflurane alone	General anesthesia maintained by administration of sevoflurane alone to keep a bispectral index between 40-60
Multimodal general anesthesia	dexmedetomidine, ketamine co-administration with sevoflurane for general anesthesia	General anesthesia maintained by co-administration of sevoflurane, dexmedetomidine and ketamine by using a predefined EEG density spectrum array pattern

Primary Outcome Measures

Name	Time	Method
Postoperative Quality of Recovery Score	Change from Baseline QoR-15 to 24 hour after surgery	Postoperative Quality of Recovery Score assessed by using the QoR-15 system

Secondary Outcome Measures

Name	Time	Method
Postoperative delirium	3 days	Postoperative delirium assessed by using the confusion assessment method (CAM) daily at least once for 3 days

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan