Deep Neuromuscular Block on Postoperative Delirium in Lumbar Surgery

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: Lumbar Spine Disease
• Intervention / Treatment: Drug: Rocuronium for deep NMB; Drug: Rocuronium for moderate NMB

• Study Type: Interventional
• Enrollment (Actual): 230
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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

Collaborators and Investigators

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

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

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: Neurologic Manifestations; Bone Diseases; Musculoskeletal Diseases; Nervous System Diseases; Mental Disorders; Postoperative Complications; Pathologic Processes; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Emergence Delirium; Delirium; Spinal Diseases; Physiological Effects of Drugs; Peripheral Nervous System Agents; Neuromuscular Agents; Neuromuscular Nondepolarizing Agents; Neuromuscular Blocking Agents; Rocuronium
• 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