Optimal TCI Regimen for Sedation of Elderly Undergoing Fiberoptic Bronchoscopy

Adverse Effects Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02927587
• Other study ID #: brofiber
• Status: Completed
• Phase: N/A
• First received: October 3, 2016
• Last updated: October 6, 2016
• Start date: November 2015
• Est. completion date: April 2016

Study information

• Verified date: October 2016
• Source: The Second Affiliated Hospital of Dalian Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: April 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 65 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Adverse Effects

Intervention

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

Locations

Country	Name	City	State
China	The Second Hospital of Dalian Medical University	Dalian	Liaoning

Sponsors (1)

Lead Sponsor	Collaborator
The Second Affiliated Hospital of Dalian Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the adverse events(apnea , hypotension or hypertension, heart rate, oxygen saturation ,any cardiac event, cough score)	Change from beginning of sedation to removal of bronchoscope	1 and 2 hours	No