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OpenTrials
Completed

NCT Number: NCT05453929

Deep Neuromuscular Block on Postoperative Delirium in Lumbar Surgery

The effect of deep neuromuscular blockade (NMB) during spine surgery reduced postoperative pain and bleeding in recent studies. Therefore by reducing these two factors, which were the contributing factors for postoperative delirium, deep NMB is expected to reduce the postoperative delirium. This study was designed to determine whether the deep NMB lowered the incidence of delirium after lumbar surgery.

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Key information

Conditions

Lumbar Spine Disease Bone Diseases Musculoskeletal Diseases Spinal Diseases

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seok Kyeong Oh

Seoul, Gangnam-gu, 06294, South Korea

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Aged 70 and more;
  • Scheduled for an elective lumbar spine surgery;
  • ASA physical status 1-3

Exclusion criteria

  • Diagnosed neuromuscular disorder;
  • Contraindications to the study drug, e. g. known allergy or hypersensitivity, hypotension, bradycardia, higher grade atrioventricular block;
  • Patient with pre-existing cognitive impairment or dementia

Treatment and study plan

Rocuronium for deep NMB

Drug

Deep neuromuscular blockade will be maintained using continuous infusion of rocuronium.

Other names: Deep NMB

Rocuronium for moderate NMB

Drug

Moderate neuromuscular blockade will be maintained using continuous infusion of rocuronium.

Other names: Moderate NMB

Primary outcomes

  1. Delirium by CAM-ICU

    Time frame: from just after surgery at the PACU to post-operative 5 days

    Occurrence of delirium assessed by CAM-ICU during the post-operative 5 days

Secondary outcomes

  1. Intramuscular pressure

    Time frame: intraoperative

    Intramuscular pressure at the para-spinal muscles

  2. Peak inspiratory airway pressure

    Time frame: intraoperative

    Peak inspiratory airway pressure (mmHg)

Sponsors and collaborators

Lead sponsor

Korea University Guro Hospital

Other

Registry information

Official study title

Effect of the Deep Neuromuscular Block on Postoperative Delirium in Elderly Patients Undergoing Lumbar Surgery

Important dates

Study start
2021
Primary completion
2024
Study completion
2025
First posted
Jul 12, 2022
Registry last updated
Jan 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.

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