Skip to main content
OpenTrials
Completed

NCT Number: NCT02927587

Optimal TCI Regimen for Sedation of Elderly Undergoing Fiberoptic Bronchoscopy

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Second Hospital of Dalian Medical University

Dalian, Liaoning, 116000, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

The induction Cet of propofol

Drug

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

Other names: propofol

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

The Second Affiliated Hospital of Dalian Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Oct 7, 2016
Registry last updated
Oct 7, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.