Multimodal GA for Lumbar Spine Surgery

National Taiwan University

Status: Completed

Conditions: Lumbar Spine Fusion Surgery

Treatments: Drug: dexmedetomidine, ketamine co-administration with sevoflurane for general anesthesia; Drug: Conventional general anesthesia by administration of sevoflurane alone

Study type: Interventional

Funder types: Other

Identifiers

NCT05247177

202112040MIND

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 60 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 2 patient groups

Multimodal general anesthesia

Experimental group

Description:

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

Treatment:

Drug: dexmedetomidine, ketamine co-administration with sevoflurane for general anesthesia

Conventional general anesthesia

Active Comparator group

Description:

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

Treatment:

Drug: Conventional general anesthesia by administration of sevoflurane alone