Clinical trial NCT02507609: Deep Neuromuscular Block on Cytokines Release and Postoperative Delirium
Official title: The Effect of Deep Neuromuscular Block on Cytokines Release and Postoperative Delirium of Elderly Patients Undergoing Total Hip Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hip Fractures
Lead sponsor: Konkuk University Medical Center
Sponsor class: OTHER
First posted: 2015-07-24
Enrollment: 82
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Interleukin 6
timeFrame: postoperative 4 hours
Secondary outcomes:
measure: postoperative delirium
timeFrame: up to postoperative day 7
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Konkuk University Medical Center
Study officials:
affiliation: Konkuk University Medical Center
name: Seong-Hyop Kim, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Oh CS, Lim HY, Jeon HJ, Kim TH, Park HJ, Piao L, Kim SH. Effect of deep neuromuscular blockade on serum cytokines and postoperative delirium in elderly patients undergoing total hip replacement: A prospective single-blind randomised controlled trial. Eur J Anaesthesiol. 2021 Mar 1;38(Suppl 1):S58-S66. doi: 10.1097/EJA.0000000000001414.