Optimal TCI Regimen for Sedation of Elderly Undergoing Fiberoptic Bronchoscopy

NCT ID: NCT02927587

Last Updated: 2016-10-07

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

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2016-04-30

Brief Summary

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Target-Controlled Infusion (TCI) of Propofol has been proved to be a safe agent for conscious sedation in flexible bronchoscopy (FB) .However, the target setting of "effect-site" concentration (Cet) of propofol is still unclear in the elderly population .The aim of this study was to compare two induction Cet of propofol in elderly patients undergoing flexible bronchoscopy.

Detailed Description

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BACKGROUND:Bronchoscopy is nowadays a very common and widespread technique that allows the physician to proceed for both diagnostic and therapeutic interventions. The risks of this procedure are low and depend mostly on the health of the patient. In our study we only considered the elderly ( age \> 65 years old) which makes the risks even higher.

Target-Controlled Infusion (TCI) of Propofol has been proved to be a safe agent for conscious sedation in flexible bronchoscopy (FB) due to its fast onset of action and rapid recovery time. By virtue of an aging population, the number of bronchoscopy performed will likely increase in the elderly patients , however, the target setting of "effect-site"concentration (Cet) of propofol is still unclear among this population.

The aim of this study was to compare two induction Cet of propofol in elderly patients undergoing flexible bronchoscopy.

METHODS: Seventy patients were randomly divided into 2 groups . All patients were of American Society of Anesthesiologists (ASA) physical status of I-III, aged more than 65 years old and between 45 and 100 kg in weight. The induction Cet was targeted respectively at 1 and 2 ug/ml. Upon reaching the modified observer's assessment of alertness/sedation(MOAA/S) score 0-3, the Cet was increased or reduced during the procedures and the Ce level was set for the maintenance of sedation. Induction time, diagnostic procedures as well as the occurrence of adverse events such as apnea , hypotension or hypertension, heart rate, oxygen saturation (SpO2) ,any cardiac event, cough score, frequency of adjustments of drug doses were recorded.

The patient will be monitored during the procedure with periodic blood pressure checks, respiratory rate, continuous electrocardiogram monitoring of heart and oxygen measurement.

Conditions

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Adverse Effects

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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The induction Cet of propofol 1

The induction Cet of propofol was targeted at 1 ug/ml.

Group Type EXPERIMENTAL

The induction Cet of propofol

Intervention Type DRUG

The induction Cet of propofol was targeted respectively at 1 and 2 ug/ml.

The induction Cet of propofol 2

The induction Cet of propofol was targeted at 2 ug/ml.

Group Type OTHER

The induction Cet of propofol

Intervention Type DRUG

The induction Cet of propofol was targeted respectively at 1 and 2 ug/ml.

Interventions

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The induction Cet of propofol

The induction Cet of propofol was targeted respectively at 1 and 2 ug/ml.

Intervention Type DRUG

Other Intervention Names

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propofol

Eligibility Criteria

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Inclusion Criteria

* body mass index \< 30 in males or \<28 in females
* an ASA physical status I and III

Exclusion Criteria

* severe sleep apnoea syndrome (apnoea-hypopnea index \> 40)
* bradycardia
* hypotension
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The Second Affiliated Hospital of Dalian Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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The Second Hospital of Dalian Medical University

Dalian, Liaoning, China

Site Status

Countries

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China

Other Identifiers

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brofiber

Identifier Type: -

Identifier Source: org_study_id

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