Deep Neuromuscular Block on Postoperative Delirium in Lumbar Surgery

Korea University

Status: Completed

Conditions: Lumbar Spine Disease

Treatments: Drug: Rocuronium for moderate NMB; Drug: Rocuronium for deep NMB

Study type: Interventional

Funder types: Other

Identifiers

NCT05453929

2021GR0301

Details and patient eligibility

About

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.

Enrollment: 230 patients

Sex: All

Ages: 70+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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230 participants in 2 patient groups

Deep NMB

Experimental group

Description:

A TOF count of 0, and a PTC of 1 to 3 will be maintained, as close to 2 twitches as possible

Treatment:

Drug: Rocuronium for deep NMB

Moderate NMB

Active Comparator group

Description:

A TOF count of 1 to 3 will be maintained, as close to 2 twitches as possible

Treatment:

Drug: Rocuronium for moderate NMB