Deep Neuromuscular Block on Cytokines Release and Postoperative Delirium

Hip Fractures Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02507609
• Other study ID #: KUH1160087
• Status: Completed
• Phase: N/A
• Start date: September 8, 2015
• Est. completion date: April 26, 2018

Study information

• Verified date: June 2018
• Source: Konkuk University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: April 26, 2018
• Est. primary completion date: April 26, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Delirium
• Hip Fractures

Intervention

Other:
• Moderate neuromuscular blockade
TOF count is maintained to 1 to 2 by intermittent intravenous injection of rocuronium bromide 5 mg during operation
• Deep neuromuscular blockade
PTC is maintained to 1 to 2 degree by continuous infusion of rocuronium bromide intravenous route

Locations

Country	Name	City	State
Korea, Republic of	Konkuk University Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Konkuk University Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Interleukin 6		postoperative 4 hours
Secondary	postoperative delirium	The incidence of postoperative delirium will be assessed by using confusion assessment method (CAM)	up to postoperative day 7