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Deep Neuromuscular Block on Postoperative Delirium in Lumbar Surgery

Primary Purpose

Lumbar Spine Disease

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Rocuronium for deep NMB
Rocuronium for moderate NMB
Sponsored by
Korea University Guro Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Lumbar Spine Disease

Eligibility Criteria

70 Years - undefined (Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Seok Kyeong Oh

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Deep NMB

Moderate NMB

Arm Description

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

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

Outcomes

Primary Outcome Measures

Delirium by CAM-ICU
Occurrence of delirium assessed by CAM-ICU during the post-operative 5 days

Secondary Outcome Measures

Intramuscular pressure
Intramuscular pressure at the para-spinal muscles
Peak inspiratory airway pressure
Peak inspiratory airway pressure (mmHg)

Full Information

First Posted
July 8, 2022
Last Updated
October 3, 2023
Sponsor
Korea University Guro Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05453929
Brief Title
Deep Neuromuscular Block on Postoperative Delirium in Lumbar Surgery
Official Title
Effect of the Deep Neuromuscular Block on Postoperative Delirium in Elderly Patients Undergoing Lumbar Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
September 16, 2021 (Actual)
Primary Completion Date
February 28, 2024 (Anticipated)
Study Completion Date
July 28, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Korea University Guro Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbar Spine Disease

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
230 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Deep NMB
Arm Type
Experimental
Arm Description
A TOF count of 0, and a PTC of 1 to 3 will be maintained, as close to 2 twitches as possible
Arm Title
Moderate NMB
Arm Type
Active Comparator
Arm Description
A TOF count of 1 to 3 will be maintained, as close to 2 twitches as possible
Intervention Type
Drug
Intervention Name(s)
Rocuronium for deep NMB
Other Intervention Name(s)
Deep NMB
Intervention Description
Deep neuromuscular blockade will be maintained using continuous infusion of rocuronium.
Intervention Type
Drug
Intervention Name(s)
Rocuronium for moderate NMB
Other Intervention Name(s)
Moderate NMB
Intervention Description
Moderate neuromuscular blockade will be maintained using continuous infusion of rocuronium.
Primary Outcome Measure Information:
Title
Delirium by CAM-ICU
Description
Occurrence of delirium assessed by CAM-ICU during the post-operative 5 days
Time Frame
from just after surgery at the PACU to post-operative 5 days
Secondary Outcome Measure Information:
Title
Intramuscular pressure
Description
Intramuscular pressure at the para-spinal muscles
Time Frame
intraoperative
Title
Peak inspiratory airway pressure
Description
Peak inspiratory airway pressure (mmHg)
Time Frame
intraoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seok Kyeong Oh, MD, PhD
Organizational Affiliation
Korea University Guro Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seok Kyeong Oh
City
Seoul
State/Province
Gangnam-gu
ZIP/Postal Code
06294
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30060380
Citation
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.
Results Reference
result
PubMed Identifier
31013693
Citation
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.
Results Reference
result
PubMed Identifier
31860601
Citation
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.
Results Reference
result
PubMed Identifier
12486343
Citation
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.
Results Reference
result

Learn more about this trial

Deep Neuromuscular Block on Postoperative Delirium in Lumbar Surgery

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