Lumbar Spine DiseaseNCT05453929
Deep Neuromuscular Block on Postoperative Delirium in Lumbar Surgery
A study testing Rocuronium for deep NMB and Rocuronium for moderate NMB in people with Lumbar Spine Disease, run by Korea University Guro Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Lumbar Spine Disease
- What is being tested?
- Rocuronium for deep NMB and Rocuronium for moderate NMB
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 230 participants
- Where
- 1 siteSouth Korea
- Study dates
- 16 Sep 2021to 2 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Aged 70 and more;
- Scheduled for an elective lumbar spine surgery;
- ASA physical status 1-3
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Lumbar Spine Disease
- Being tested
- Rocuronium for deep NMB, Rocuronium for moderate NMB
- Medical subject headings
- Spinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rocuronium for deep NMBDrug
Also called Deep NMB
Deep neuromuscular blockade will be maintained using continuous infusion of rocuronium.
Rocuronium for moderate NMBDrug
Also called Moderate NMB
Moderate neuromuscular blockade will be maintained using continuous infusion of rocuronium.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Rocuronium for moderate NMB |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delirium by CAM-ICU
Occurrence of delirium assessed by CAM-ICU during the post-operative 5 days
Measured: from just after surgery at the PACU to post-operative 5 days
Secondary outcomes (2)
Intramuscular pressure
Intramuscular pressure at the para-spinal muscles
Measured: intraoperative
Peak inspiratory airway pressure
Peak inspiratory airway pressure (mmHg)
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2022
- Study start16 Sep 2021
- Primary completion20 Dec 2024
- Study completion2 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Lumbar Spine DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 230 participants (actual)
Sponsor and investigators
- Lead sponsor
- Korea University Guro Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seok Kyeong Oh, Korea University Guro Hospital
- Investigators
- Seok Kyeong Oh, MD, PhD, Principal investigator, Korea University Guro Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05453929
- Sponsor's protocol ID
- 2021GR0301
- Status last verified
- Jan 2025
- First submitted
- 8 Jul 2022
- Last updated
- 3 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 30060380Oh 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.
PubMed 31013693Kang 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.
PubMed 31860601Taylor 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.
PubMed 12486343
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Deep Neuromuscular Block on Postoperative Delirium in Elderly Patients Undergoing Lumbar Surgery
- ClinicalTrials.gov ID
- NCT05453929
- Acronym / sponsor ID
- 2021GR0301
- Conditions
- Lumbar Spine Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- Korea University Guro HospitalUniversity, hospital or other
- Study start
- 16 Sep 2021 (actual)
- Primary completion
- 20 Dec 2024 (actual)
- Study completion
- 2 Jan 2025 (actual)
- First posted
- 12 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Deep NMB | Experimental | Drug: Rocuronium for deep NMBA TOF count of 0, and a PTC of 1 to 3 will be maintained, as close to 2 twitches as possible |
| Moderate NMB | Active comparator | Drug: Rocuronium for moderate NMBA TOF count of 1 to 3 will be maintained, as close to 2 twitches as possible |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Aged 70 and more;
- Scheduled for an elective lumbar spine surgery;
- ASA physical status 1-3
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rocuronium for deep NMBAlso: Deep NMBDeep neuromuscular blockade will be maintained using continuous infusion of rocuronium. | Drug | Deep NMB |
| Rocuronium for moderate NMBAlso: Moderate NMBModerate neuromuscular blockade will be maintained using continuous infusion of rocuronium. | Drug | Moderate NMB |
Primary outcome
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
2 secondary outcomes
Intramuscular pressure
Time frame: intraoperative
Peak inspiratory airway pressure
Time frame: intraoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2025.
- Results publication: PubMed 30060380Morino 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 publication: PubMed 31013693Oh 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 publication: PubMed 31860601Kang 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 publication: PubMed 12486343Taylor 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Seok Kyeong Oh, MD, PhD principal investigator
Korea University Guro Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rocuronium for deep NMB and Rocuronium for moderate NMB in people with Lumbar Spine Disease, run by Korea University Guro Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Delirium by CAM-ICU (time frame: from just after surgery at the PACU to post-operative 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05453929, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2025.