Deep Neuromuscular Block on Cytokines Release and Postoperative Delirium

Konkuk University Medical Center

Status

Completed

Conditions

Hip Fractures

Treatments

Other: Moderate neuromuscular blockade

Other: Deep neuromuscular blockade

Study type

Interventional

Funder types

Other

Identifiers

NCT02507609

KUH1160087

Details and patient eligibility

About

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.

Full 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

Enrollment

82 patients

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

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