Deep Neuromuscular Block on Postoperative Delirium in Lumbar Surgery

January 2, 2025 updated by: Seok Kyeong Oh, Korea University Guro Hospital

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

230

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gangnam-gu
      • Seoul, Gangnam-gu, Korea, Republic of, 06294
        • Seok Kyeong Oh

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

70 years and older (Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Deep NMB
A TOF count of 0, and a PTC of 1 to 3 will be maintained, as close to 2 twitches as possible
Drug: Rocuronium for deep NMB
Deep neuromuscular blockade will be maintained using continuous infusion of rocuronium.
Other Names:
  • Deep NMB
Active Comparator: Moderate NMB
A TOF count of 1 to 3 will be maintained, as close to 2 twitches as possible
Drug: Rocuronium for moderate NMB
Moderate neuromuscular blockade will be maintained using continuous infusion of rocuronium.
Other Names:
  • Moderate NMB

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
from just after surgery at the PACU to post-operative 5 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intramuscular pressure
Time Frame: intraoperative
Intramuscular pressure at the para-spinal muscles
intraoperative
Peak inspiratory airway pressure
Time Frame: intraoperative
Peak inspiratory airway pressure (mmHg)
intraoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Korea University Guro Hospital

Investigators

  • Principal Investigator: Seok Kyeong Oh, MD, PhD, Korea University Guro Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 16, 2021

Primary Completion (Actual)

December 20, 2024

Study Completion (Actual)

January 2, 2025

Study Registration Dates

First Submitted

July 8, 2022

First Submitted That Met QC Criteria

July 8, 2022

First Posted (Actual)

July 12, 2022

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 2, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021GR0301

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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