Deep Neuromuscular Block on Postoperative Delirium in Lumbar Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

230 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-16

Study Completion Date

2025-01-02

Brief Summary

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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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Detailed Description

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Conditions

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Lumbar Spine Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Deep NMB

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

Group Type EXPERIMENTAL

Rocuronium for deep NMB

Intervention Type DRUG

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

Moderate NMB

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

Group Type ACTIVE_COMPARATOR

Rocuronium for moderate NMB

Intervention Type DRUG

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

Interventions

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Rocuronium for deep NMB

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

Intervention Type DRUG

Rocuronium for moderate NMB

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

Intervention Type DRUG

Other Intervention Names

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Deep NMB Moderate NMB

Eligibility Criteria

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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

Minimum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No