Deep Neuromuscular Block on Cytokines Release and Postope... | NCT02507609

Studies
Deep Neuromuscular Block on Cytokines Release and Postoperative Delirium

NCT02507609

Sponsor

Konkuk University Medical Center

Status

Completed

Last Update Posted

Jun 20, 2018Actual

Enrollment

82Actual

Phase

Not Applicable

Conditions

Hip Fractures

Interventions

Moderate neuromuscular blockade
Deep neuromuscular blockade

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 8, 2015Actual

Primary Completion Date

Apr 26, 2018Actual

Completion Date

Apr 26, 2018Actual

First Submitted Date

Jul 21, 2015

First Submission Date that Met QC Criteria

Jul 23, 2015

First Posted Date

Jul 24, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 18, 2018

Last Update Posted Date

Jun 20, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Seong-Hyop Kim, Associate Professor, Konkuk University Medical CenterPrincipal Investigator

Lead Sponsor

Konkuk University Medical CenterOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

82Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
M group	Active Comparator	moderate neuromuscular blockade group by intermittent injection of rocuronium bromide	Other: Moderate neuromuscular blockade
D group	Active Comparator	deep neuromuscular blockade group by continuous infusion of rocuronium bromide	Other: Deep neuromuscular blockade

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Moderate neuromuscular blockade	Other	TOF count is maintained to 1 to 2 by intermittent intravenous injection of rocuronium bromide 5 mg during operation	M group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Interleukin 6		postoperative 4 hours

Secondary Outcomes

Measure	Description	Time Frame
postoperative delirium	The incidence of postoperative delirium will be assessed by using confusion assessment method (CAM)	up to postoperative day 7

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All adult (more than 50 years old) patients scheduled for total hip arthroplasty and total knee arthroplasty who have signed the written informed consent.

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Seong-Hyop Kim, M.D.	Konkuk University Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Konkuk University Medical Center		Seoul		143-729	South Korea

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
33399376	Derived	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.

Type	Date	Date Unknown
Release	Oct 24, 2019
Reset	Nov 13, 2019

ID	Term
D005264	Femoral Fractures
D050723	Fractures, Bone
D014947	Wounds and Injuries
D025981	Hip Injuries

ID	Term
D000732	Androstanols
D000731	Androstanes
D013256	Steroids
D000072473	Fused-Ring Compounds