Hip FracturesNCT02507609
Deep Neuromuscular Block on Cytokines Release and Postoperative Delirium
A study testing Moderate neuromuscular blockade and Deep neuromuscular blockade in people with Hip Fractures, run by Konkuk University Medical Center at 1 site in South Korea.
Trial summary
The purpose of the study is to determine the relationship between the degree of neuromuscular block, the release of cytokines and clinical outcomes in elderly patients undergoing orthopedic surgery. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Hip Fractures
- What is being tested?
- Moderate neuromuscular blockade and Deep neuromuscular blockade
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteSouth Korea
- Study dates
- 8 Sep 2015to 26 Apr 2018
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All adult (more than 50 years old) patients scheduled for total hip arthroplasty and total knee arthroplasty who have signed the written informed consent.
Who cannot join
- Inability to give informed consent
- Preexisting cognitive dysfunction or delirium
- Known allergy to rocuronium sugammadex
- Underlying liver dysfunction (AST and ALT more than 100 IU/l)
- Underlying kidney dysfunction (Serum Creatinine more than 1.5 mg/dl)
- Underlying neuromuscular disease
- Patients taking any medication with potential interference with neuromuscular transmission
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Deep Neuromuscular Block on Cytokines Release and Postoperative Delirium of Elderly Patients Undergoing Total Hip Arthroplasty
The purpose of the study is to determine the relationship between the degree of neuromuscular block, the release of cytokines and clinical outcomes in elderly patients undergoing orthopedic surgery. Investigators hypothesize that deep neuromuscular blockade decreases the release of cytokine and the incidence of postoperative delirium in elderly patients undergoing orthopedic surgery, compared with moderate neuromuscular blockade.
Read the detailed description
- Study design
- This is a prospective, randomized, single blinded study.
- Measurement values
- Neuromuscular monitoring by post-tetanic count (PTC) during operation
- Regional cerebral oxygen saturation monitoring
- Mean systemic blood pressure (MBP), heart rate (HR)
- Cardiac index (CI), using non-invasive cardiac output monitor
- IL-1ß, IL-6, TNF-α, IL-10 and CRP
- Arterial blood gas analysis (ABGA)
- Laboratory values [Hemoglobin, Hematocrit, serum albumin, creatinine, CPK, LDH]
- Postoperative pain, using visual analogue scale (VAS)
- Postoperative nausea and vomiting (PONV)
- Total infused amounts of drugs
- Total anesthesia duration, intubation duration and operation duration
- Intubation duration, operation duration
- Incidence of postoperative intensive care unit (ICU) admission
- Total ICU staying duration, if patients admit to ICU
- Preoperative and postoperative left ventricular ejection fraction change
- Incidence of hypotension (mean blood pressure lesser than 60 mmHg)
- Incidence of postoperative delirium using confusion assessment method (CAM) intensive care unit (ICU)
- Total amount of blood products transfusion (paced red blood cells, fresh frozen plasma, platelet concentration, cryoprecipitate)
- Total amount of crystalloids and colloids infusion
- Total amount urine output
- Conditions
- Hip Fractures
- Being tested
- Moderate neuromuscular blockade, Deep neuromuscular blockade
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moderate neuromuscular blockadeOther
Also called Esmeron
TOF count is maintained to 1 to 2 by intermittent intravenous injection of rocuronium bromide 5 mg during operation
Deep neuromuscular blockadeOther
Also called Esmeron
PTC is maintained to 1 to 2 degree by continuous infusion of rocuronium bromide intravenous route
| Study group | Role | What they receive |
|---|---|---|
| M group | Active comparator | moderate neuromuscular blockade group by intermittent injection of rocuronium bromide Receives: Other: Moderate neuromuscular blockade |
| D group | Active comparator | deep neuromuscular blockade group by continuous infusion of rocuronium bromide Receives: Other: Deep neuromuscular blockade |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interleukin 6
Measured: postoperative 4 hours
Secondary outcomes (1)
postoperative delirium
The incidence of postoperative delirium will be assessed by using confusion assessment method (CAM)
Measured: up to postoperative day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2015 (estimated)
- Study start8 Sep 2015
- Primary completion26 Apr 2018
- Study completion26 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hip FracturesStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Konkuk University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seong-Hyop Kim, Konkuk University Medical Center
- Investigators
- Seong-Hyop Kim, M.D., Principal investigator, Konkuk University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02507609
- Sponsor's protocol ID
- KUH1160087
- Status last verified
- Jun 2018
- First submitted
- 21 Jul 2015
- Last updated
- 20 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Oh CS, Lim HY, Jeon HJ, Kim TH, Park HJ, Piao L, Kim SH. Effect of deep neuromuscular blockade on serum cytokines and postoperative delirium in elderly patients undergoing total hip replacement: A prospective single-blind randomised controlled trial. Eur J Anaesthesiol. 2021 Mar 1;38(Suppl 1):S58-S66. doi: 10.1097/EJA.0000000000001414.
PubMed 33399376
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Deep Neuromuscular Block on Cytokines Release and Postoperative Delirium of Elderly Patients Undergoing Total Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT02507609
- Acronym / sponsor ID
- KUH1160087
- Conditions
- Hip Fractures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Konkuk University Medical CenterUniversity, hospital or other
- Study start
- 8 Sep 2015 (actual)
- Primary completion
- 26 Apr 2018 (actual)
- Study completion
- 26 Apr 2018 (actual)
- First posted
- 24 Jul 2015 (estimated)
- 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 purpose of the study is to determine the relationship between the degree of neuromuscular block, the release of cytokines and clinical outcomes in elderly patients undergoing orthopedic surgery. Investigators hypothesize that deep neuromuscular blockade decreases the release of cytokine and the incidence of postoperative delirium in elderly patients undergoing orthopedic surgery, compared with moderate neuromuscular blockade.
Detailed description
- Study design
- This is a prospective, randomized, single blinded study.
- Measurement values
- Neuromuscular monitoring by post-tetanic count (PTC) during operation
- Regional cerebral oxygen saturation monitoring
- Mean systemic blood pressure (MBP), heart rate (HR)
- Cardiac index (CI), using non-invasive cardiac output monitor
- IL-1ß, IL-6, TNF-α, IL-10 and CRP
- Arterial blood gas analysis (ABGA)
- Laboratory values [Hemoglobin, Hematocrit, serum albumin, creatinine, CPK, LDH]
- Postoperative pain, using visual analogue scale (VAS)
- Postoperative nausea and vomiting (PONV)
- Total infused amounts of drugs
- Total anesthesia duration, intubation duration and operation duration
- Intubation duration, operation duration
- Incidence of postoperative intensive care unit (ICU) admission
- Total ICU staying duration, if patients admit to ICU
- Preoperative and postoperative left ventricular ejection fraction change
- Incidence of hypotension (mean blood pressure lesser than 60 mmHg)
- Incidence of postoperative delirium using confusion assessment method (CAM) intensive care unit (ICU)
- Total amount of blood products transfusion (paced red blood cells, fresh frozen plasma, platelet concentration, cryoprecipitate)
- Total amount of crystalloids and colloids infusion
- Total amount urine output
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| M group | Active comparator | Other: Moderate neuromuscular blockademoderate neuromuscular blockade group by intermittent injection of rocuronium bromide |
| D group | Active comparator | Other: Deep neuromuscular blockadedeep neuromuscular blockade group by continuous infusion of rocuronium bromide |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All adult (more than 50 years old) patients scheduled for total hip arthroplasty and total knee arthroplasty who have signed the written informed consent.
Key exclusion criteria (7 listed)
- Inability to give informed consent
- Preexisting cognitive dysfunction or delirium
- Known allergy to rocuronium sugammadex
- Underlying liver dysfunction (AST and ALT more than 100 IU/l)
- Underlying kidney dysfunction (Serum Creatinine more than 1.5 mg/dl)
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 |
|---|---|---|
| Moderate neuromuscular blockadeAlso: EsmeronTOF count is maintained to 1 to 2 by intermittent intravenous injection of rocuronium bromide 5 mg during operation | Other | M group |
| Deep neuromuscular blockadeAlso: EsmeronPTC is maintained to 1 to 2 degree by continuous infusion of rocuronium bromide intravenous route | Other | D group |
Primary outcome
Interleukin 6
Time frame: postoperative 4 hours
1 secondary outcome
postoperative delirium
Time frame: up to postoperative day 7
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 20 Jun 2018.
- Derived from this study: PubMed 33399376Oh CS, Lim HY, Jeon HJ, Kim TH, Park HJ, Piao L, Kim SH. Effect of deep neuromuscular blockade on serum cytokines and postoperative delirium in elderly patients undergoing total hip replacement: A prospective single-blind randomised controlled trial. Eur J Anaesthesiol. 2021 Mar 1;38(Suppl 1):S58-S66. doi: 10.1097/EJA.0000000000001414.
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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.
Seong-Hyop Kim, M.D. principal investigator
Konkuk University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moderate neuromuscular blockade and Deep neuromuscular blockade in people with Hip Fractures, run by Konkuk University Medical Center 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 1 inclusion and 7 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 20 Jun 2018. 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?
Interleukin 6 (time frame: postoperative 4 hours). 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 NCT02507609, which also lists 1 linked publication.
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 20 Jun 2018.