Deep Neuromuscular Block on Cytokines Release and Postoperative Delirium

Study Overview
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Brief Summary
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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
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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

Official Title
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The Effect of Deep Neuromuscular Block on Cytokines Release and Postoperative Delirium of Elderly Patients Undergoing Total Hip Arthroplasty

Conditions
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Hip Fractures

Intervention / Treatment
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* Other: Moderate neuromuscular blockade
* Other: Deep neuromuscular blockade


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: M group<br>moderate neuromuscular blockade group by intermittent injection of rocuronium bromide | Other: Moderate neuromuscular blockade<br>* TOF count is maintained to 1 to 2 by intermittent intravenous injection of rocuronium bromide 5 mg during operation<br>* Other names: Esmeron;|
| Active Comparator: D group<br>deep neuromuscular blockade group by continuous infusion of rocuronium bromide | Other: Deep neuromuscular blockade<br>* PTC is maintained to 1 to 2 degree by continuous infusion of rocuronium bromide intravenous route<br>* Other names: Esmeron;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Interleukin 6 |  | postoperative 4 hours | 

Secondary Outcome Measures

| Outcome Measure | 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 |