Deep Neuromuscular Block on Cytokines Release and Postoperative Delirium

Last updated: June 18, 2018
Sponsor: Konkuk University Medical Center
Overall Status: Completed

Phase

N/A

Condition

Dementia

Osteoporosis

Treatment

N/A

Clinical Study ID

NCT02507609
KUH1160087
  • Ages > 50
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • All adult (more than 50 years old) patients scheduled for total hip arthroplasty andtotal knee arthroplasty who have signed the written informed consent.

Exclusion

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 neuromusculartransmission

Study Design

Total Participants: 82
Study Start date:
September 08, 2015
Estimated Completion Date:
April 26, 2018

Study 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

Connect with a study center

  • Konkuk University Medical Center

    Seoul, 143-729
    Korea, Republic of

    Site Not Available

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