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Completed

NCT Number: NCT02507609

Deep Neuromuscular Block on Cytokines Release and Postoperative Delirium

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.

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Konkuk University Medical Center

Seoul, 143-729, South Korea

About this study

  • 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Moderate neuromuscular blockade

Other

TOF count is maintained to 1 to 2 by intermittent intravenous injection of rocuronium bromide 5 mg during operation

Other names: Esmeron

Deep neuromuscular blockade

Other

PTC is maintained to 1 to 2 degree by continuous infusion of rocuronium bromide intravenous route

Other names: Esmeron

Primary outcomes

  1. Interleukin 6

    Time frame: postoperative 4 hours

Secondary outcomes

  1. postoperative delirium

    Time frame: up to postoperative day 7

    The incidence of postoperative delirium will be assessed by using confusion assessment method (CAM)

Sponsors and collaborators

Lead sponsor

Konkuk University Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Jul 24, 2015
Registry last updated
Jun 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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