Adverse Effects Clinical Trial
Official title:
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.
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.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention
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