Deep Neuromuscular Block on Cytokines Release and Postoperative Delirium

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-08

Study Completion Date

2018-04-26

Brief Summary

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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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Detailed Description

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* 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

Conditions

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Hip Fractures

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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M group

moderate neuromuscular blockade group by intermittent injection of rocuronium bromide

Group Type ACTIVE_COMPARATOR

Moderate neuromuscular blockade

Intervention Type OTHER

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

D group

deep neuromuscular blockade group by continuous infusion of rocuronium bromide

Group Type ACTIVE_COMPARATOR

Deep neuromuscular blockade

Intervention Type OTHER

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

Interventions

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Moderate neuromuscular blockade

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

Intervention Type OTHER

Deep neuromuscular blockade

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

Intervention Type OTHER

Other Intervention Names

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Esmeron Esmeron

Eligibility Criteria

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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

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No