Deep Neuromuscular Block on Postoperative Delirium in Lumbar Surgery

Not Applicable

Completed

• Conditions: Lumbar Spine Disease
• Interventions: Drug: Rocuronium for moderate NMB; Drug: Rocuronium for deep NMB

• Registration Number: NCT05453929
• Lead Sponsor: Korea University Guro Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-09-16
• Study First Submitted: 2022-07-08
• Study First Submitted QC: 2022-07-08
• Study First Posted: 2022-07-12
• Primary Completion: 2024-12-20
• Status Verified: 2025-01
• Study Completion: 2025-01-02
• Last Update Submitted: 2025-01-02
• Last Update Posted: 2025-01-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 230

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Moderate NMB	Rocuronium for moderate NMB	A TOF count of 1 to 3 will be maintained, as close to 2 twitches as possible
Deep NMB	Rocuronium for deep NMB	A TOF count of 0, and a PTC of 1 to 3 will be maintained, as close to 2 twitches as possible

Primary Outcome Measures

Name	Time	Method
Delirium by CAM-ICU	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 Outcome Measures

Name	Time	Method
Intramuscular pressure	intraoperative	Intramuscular pressure at the para-spinal muscles
Peak inspiratory airway pressure	intraoperative	Peak inspiratory airway pressure (mmHg)

Trial Locations

Locations (1)

Seok Kyeong Oh; 🇰🇷 Seoul, Gangnam-gu, Korea, Republic of