NCT05453929

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
230

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 16, 2021

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

July 8, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 12, 2022

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2024

Completed
13 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 2, 2025

Completed
Last Updated

January 3, 2025

Status Verified

January 1, 2025

Enrollment Period

3.3 years

First QC Date

July 8, 2022

Last Update Submit

January 2, 2025

Conditions

Lumbar Spine Disease

Outcome Measures

Primary Outcomes (1)

  • Delirium by CAM-ICU

    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 Outcomes (2)

  • Intramuscular pressure

    intraoperative

  • Peak inspiratory airway pressure

    intraoperative

Study Arms (2)

Deep NMB

EXPERIMENTAL

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

Moderate NMB

ACTIVE COMPARATOR

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

Drug: Rocuronium for moderate NMB

Interventions

Rocuronium for deep NMBDRUG

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

Also known as: Deep NMB
Deep NMB
Rocuronium for moderate NMBDRUG

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

Also known as: Moderate NMB
Moderate NMB

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seok Kyeong Oh

Seoul, Gangnam-gu, 06294, South Korea

Location

Related Publications (4)

  • Morino T, Hino M, Yamaoka S, Misaki H, Ogata T, Imai H, Miura H. Risk Factors for Delirium after Spine Surgery: An Age-Matched Analysis. Asian Spine J. 2018 Aug;12(4):703-709. doi: 10.31616/asj.2018.12.4.703. Epub 2018 Jul 27.

    PMID: 30060380RESULT

  • Oh SK, Kwon WK, Park S, Ji SG, Kim JH, Park YK, Lee SY, Lim BG. Comparison of Operating Conditions, Postoperative Pain and Recovery, and Overall Satisfaction of Surgeons with Deep vs. No Neuromuscular Blockade for Spinal Surgery under General Anesthesia: A Prospective Randomized Controlled Trial. J Clin Med. 2019 Apr 12;8(4):498. doi: 10.3390/jcm8040498.

    PMID: 31013693RESULT

  • Kang WS, Oh CS, Rhee KY, Kang MH, Kim TH, Lee SH, Kim SH. Deep neuromuscular blockade during spinal surgery reduces intra-operative blood loss: A randomised clinical trial. Eur J Anaesthesiol. 2020 Mar;37(3):187-195. doi: 10.1097/EJA.0000000000001135.

    PMID: 31860601RESULT

  • Taylor H, McGregor AH, Medhi-Zadeh S, Richards S, Kahn N, Zadeh JA, Hughes SP. The impact of self-retaining retractors on the paraspinal muscles during posterior spinal surgery. Spine (Phila Pa 1976). 2002 Dec 15;27(24):2758-62. doi: 10.1097/00007632-200212150-00004.

    PMID: 12486343RESULT

MeSH Terms

Conditions

Spinal Diseases

Interventions

Rocuronium

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

AndrostanolsAndrostanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Seok Kyeong Oh, MD, PhD

    Korea University Guro Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 8, 2022

First Posted

July 12, 2022

Study Start

September 16, 2021

Primary Completion

December 20, 2024

Study Completion

January 2, 2025

Last Updated

January 3, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)