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Clinical 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. 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.


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT02507609
Study type Interventional
Source Konkuk University Medical Center
Contact
Status Completed
Phase N/A
Start date September 8, 2015
Completion date April 26, 2018

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