Optimal TCI Regimen for Sedation of Elderly Undergoing Fiberoptic Bronchoscopy

Not Applicable

Completed

• Conditions: Adverse Effects
• Interventions: Drug: The induction Cet of propofol

• Registration Number: NCT02927587
• Lead Sponsor: The Second Affiliated Hospital of Dalian Medical University

Brief Summary

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

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 Timeline

• Study Start: 2015-11
• Primary Completion: 2016-03
• Study Completion: 2016-04
• Status Verified: 2016-10
• Study First Submitted: 2016-10-03
• Study First Submitted QC: 2016-10-06
• Last Update Submitted: 2016-10-06
• Study First Posted: 2016-10-07
• Last Update Posted: 2016-10-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
The induction Cet of propofol 1	The induction Cet of propofol	The induction Cet of propofol was targeted at 1 ug/ml.
The induction Cet of propofol 2	The induction Cet of propofol	The induction Cet of propofol was targeted at 2 ug/ml.

Primary Outcome Measures

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

Trial Locations

Locations (1)

The Second Hospital of Dalian Medical University; 🇨🇳 Dalian, Liaoning, China