Optimal TCI Regimen for Sedation of Elderly Undergoing Fiberoptic Bronchoscopy

October 6, 2016 updated by: The Second Affiliated Hospital of Dalian Medical University

Optimal TCI Regimen for Sedation of Elderly Undergoing Fiberoptic Bronchoscopy: A Prospective Randomized Controlled Trial.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Liaoning
      • Dalian, Liaoning, China, 116000
        • The Second Hospital of Dalian Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: The induction Cet of propofol 1
The induction Cet of propofol was targeted at 1 ug/ml.
Drug: The induction Cet of propofol
The induction Cet of propofol was targeted respectively at 1 and 2 ug/ml.
Other Names:
  • propofol
Other: The induction Cet of propofol 2
The induction Cet of propofol was targeted at 2 ug/ml.
Drug: The induction Cet of propofol
The induction Cet of propofol was targeted respectively at 1 and 2 ug/ml.
Other Names:
  • propofol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the adverse events(apnea , hypotension or hypertension, heart rate, oxygen saturation ,any cardiac event, cough score)
Time Frame: 1 and 2 hours
Change from beginning of sedation to removal of bronchoscope
1 and 2 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Second Affiliated Hospital of Dalian Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2015

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

October 3, 2016

First Submitted That Met QC Criteria

October 6, 2016

First Posted (Estimate)

October 7, 2016

Study Record Updates

Last Update Posted (Estimate)

October 7, 2016

Last Update Submitted That Met QC Criteria

October 6, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • brofiber

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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