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OpenTrials
Completed

NCT Number: NCT05247177

Multimodal GA for Lumbar Spine Surgery

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

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Key information

Conditions

Lumbar Spine Fusion Surgery

Age range

60 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Taiwan University Hospital

Taipei, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients with ages at least 60-year undergoing elective lumbar spine surgery

Exclusion:

  • A history of dementia
  • Impaired liver function, eg. AST or ALT >100; liver cirrhosis > Child B class
  • Impaired renal function, cGFR< 60 ml/min/1.73 m2
  • Cardiac dysfunction, such as heart failure > NYHA class II

Treatment and study plan

dexmedetomidine, ketamine co-administration with sevoflurane for general anesthesia

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 by administration of sevoflurane alone

Drug

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

Primary outcomes

  1. Postoperative Quality of Recovery Score

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

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

Secondary outcomes

  1. Postoperative delirium

    Time frame: 3 days

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

  2. Postoperative chronic pain

    Time frame: 3 months

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

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Feb 18, 2022
Registry last updated
Oct 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.