Deep Neuromuscular Block on Cytokines Release and Postoperative Delirium

Not Applicable

Completed

• Conditions: Hip Fractures
• Interventions: Other: Deep neuromuscular blockade; Other: Moderate neuromuscular blockade

• Registration Number: NCT02507609
• Lead Sponsor: Konkuk University Medical Center

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

Study Timeline

• Study First Submitted: 2015-07-21
• Study First Submitted QC: 2015-07-23
• Study First Posted: 2015-07-24
• Study Start: 2015-09-08
• Primary Completion: 2018-04-26
• Study Completion: 2018-04-26
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-18
• Last Update Posted: 2018-06-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 82

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
D group	Deep neuromuscular blockade	deep neuromuscular blockade group by continuous infusion of rocuronium bromide
M group	Moderate neuromuscular blockade	moderate neuromuscular blockade group by intermittent injection of rocuronium bromide

Primary Outcome Measures

Name	Time	Method
Interleukin 6	postoperative 4 hours

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Konkuk University Medical Center; 🇰🇷 Seoul, Korea, Republic of