NCT02507609

Deep Neuromuscular Block on Cytokines Release and Postoperative Delirium

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 82 (actual)
• Sponsor: Konkuk University Medical Center · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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

Conditions

• Hip Fractures

Interventions

Type	Name	Description
OTHER	Moderate neuromuscular blockade	TOF count is maintained to 1 to 2 by intermittent intravenous injection of rocuronium bromide 5 mg during operation
OTHER	Deep neuromuscular blockade	PTC is maintained to 1 to 2 degree by continuous infusion of rocuronium bromide intravenous route

Timeline

• Start date: 2015-09-08
• Primary completion: 2018-04-26
• Completion: 2018-04-26
• First posted: 2015-07-24
• Last updated: 2018-06-20

Locations

1 site across 1 country: South Korea