Multimodal GA for Lumbar Spine Surgery

National Taiwan University Hospital100 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

100

Conditions

Lumbar Spine Fusion Surgery

Interventions

dexmedetomidine, ketamine co-administration with sevoflurane for general anesthesiaDRUG

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

Conventional general anesthesia by administration of sevoflurane aloneDRUG

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

Eligibility

Sex: ALLMin age: 60 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Locations (1)

National Taiwan University Hospital

Taipei, Taiwan

Outcomes

Primary Outcomes

Postoperative Quality of Recovery Score

Postoperative Quality of Recovery Score assessed by using the QoR-15 system

Time frame: Change from Baseline QoR-15 to 24 hour after surgery

Secondary Outcomes

Postoperative delirium

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

Time frame: 3 days

Postoperative chronic pain

Postoperative chronic pain intensity at 3 months after surgery assessed by using the Brief Pain Inventory questionnaire.

Time frame: 3 months

Data from ClinicalTrials.gov

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