Deep Neuromuscular Block on Cytokines Release and Postoperative Delirium

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

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.

Study Overview

• Status: Completed
• Conditions: Hip Fractures
• Intervention / Treatment: Other: Moderate neuromuscular blockade; Other: Deep 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 Type: Interventional
• Enrollment (Actual): 82
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 143-729
    • Konkuk University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: M group; moderate neuromuscular blockade group by intermittent injection of rocuronium bromide	Other: Moderate neuromuscular blockade; TOF count is maintained to 1 to 2 by intermittent intravenous injection of rocuronium bromide 5 mg during operation; Other Names: Esmeron
Active Comparator: D group; deep neuromuscular blockade group by continuous infusion of rocuronium bromide	Other: Deep neuromuscular blockade; PTC is maintained to 1 to 2 degree by continuous infusion of rocuronium bromide intravenous route; Other Names: Esmeron

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Interleukin 6	postoperative 4 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
postoperative delirium	The incidence of postoperative delirium will be assessed by using confusion assessment method (CAM)	up to postoperative day 7

Collaborators and Investigators

• Sponsor: Konkuk University Medical Center
• Investigators: Principal Investigator: Seong-Hyop Kim, M.D., Konkuk University Medical Center

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 8, 2015
• Primary Completion (Actual): April 26, 2018
• Study Completion (Actual): April 26, 2018

Study Registration Dates

• First Submitted: July 21, 2015
• First Submitted That Met QC Criteria: July 23, 2015
• First Posted (Estimate): July 24, 2015

Study Record Updates

• Last Update Posted (Actual): June 20, 2018
• Last Update Submitted That Met QC Criteria: June 18, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Fractures, Bone; Wounds and Injuries; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Leg Injuries; Femoral Fractures; Hip Injuries; Delirium; Hip Fractures; Physiological Effects of Drugs; Peripheral Nervous System Agents; Neuromuscular Agents; Neuromuscular Nondepolarizing Agents; Neuromuscular Blocking Agents; Rocuronium
• Other Study ID Numbers: KUH1160087