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Deep Neuromuscular Block on Cytokines Release and Postoperative Delirium

Primary Purpose

Hip Fractures

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Moderate neuromuscular blockade
Deep neuromuscular blockade
Sponsored by
Konkuk University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hip Fractures

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Konkuk University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

M group

D group

Arm Description

moderate neuromuscular blockade group by intermittent injection of rocuronium bromide

deep neuromuscular blockade group by continuous infusion of rocuronium bromide

Outcomes

Primary Outcome Measures

Interleukin 6

Secondary Outcome Measures

postoperative delirium
The incidence of postoperative delirium will be assessed by using confusion assessment method (CAM)

Full Information

First Posted
July 21, 2015
Last Updated
June 18, 2018
Sponsor
Konkuk University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02507609
Brief Title
Deep Neuromuscular Block on Cytokines Release and Postoperative Delirium
Official Title
The Effect of Deep Neuromuscular Block on Cytokines Release and Postoperative Delirium of Elderly Patients Undergoing Total Hip Arthroplasty
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
September 8, 2015 (Actual)
Primary Completion Date
April 26, 2018 (Actual)
Study Completion Date
April 26, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Konkuk University Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Fractures

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
82 (Actual)

8. Arms, Groups, and Interventions

Arm Title
M group
Arm Type
Active Comparator
Arm Description
moderate neuromuscular blockade group by intermittent injection of rocuronium bromide
Arm Title
D group
Arm Type
Active Comparator
Arm Description
deep neuromuscular blockade group by continuous infusion of rocuronium bromide
Intervention Type
Other
Intervention Name(s)
Moderate neuromuscular blockade
Other Intervention Name(s)
Esmeron
Intervention Description
TOF count is maintained to 1 to 2 by intermittent intravenous injection of rocuronium bromide 5 mg during operation
Intervention Type
Other
Intervention Name(s)
Deep neuromuscular blockade
Other Intervention Name(s)
Esmeron
Intervention Description
PTC is maintained to 1 to 2 degree by continuous infusion of rocuronium bromide intravenous route
Primary Outcome Measure Information:
Title
Interleukin 6
Time Frame
postoperative 4 hours
Secondary Outcome Measure Information:
Title
postoperative delirium
Description
The incidence of postoperative delirium will be assessed by using confusion assessment method (CAM)
Time Frame
up to postoperative day 7

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seong-Hyop Kim, M.D.
Organizational Affiliation
Konkuk University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Konkuk University Medical Center
City
Seoul
ZIP/Postal Code
143-729
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
33399376
Citation
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.
Results Reference
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Deep Neuromuscular Block on Cytokines Release and Postoperative Delirium

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