The median effective dose (ED50) of intravenous oxycodone depending on sex and age for attenuation of intubation-related hemodynamic responses
- Conditions
- Not Applicable
- Registration Number
- KCT0002491
- Lead Sponsor
- Chosun University Hospital
- Brief Summary
Background/aim: Preoperative intravenous oxycodone may help to prevent or attenuate intubation-related hemodynamic responses (IRHRs), but its pharmacokinetics differs according to age and sex. Therefore, we investigated the 95% effective dose (ED95) of intravenous oxycodone for attenuating all IRHRs, depending on the age and sex of the study population. Materials and methods: All patients were allocated to one of 6 groups: 1) 20-40 year old males, 2) 41-65yearold males, 3) 66-80 year old males, 4) 20-40 year old females, 5) 41-65yearold females, and 6) 66-80 year old females (groups YM, OM, EM, YF, OF, and EF, respectively). Using Dixon's up-and-down method, the first patient in each group was slowly injected with intravenous oxycodone (0.1 mg/kg) 20 min before intubation. The subsequent patient received the next oxycodone dose, which was decreased or increased by 0.01 mg/kg, depending on the "success" or "failure" of attenuation of all IRHRs to within 20% of the baseline values at 1 min after intubation in the previous patient. After obtaining 8 crossover points, predictive ED95 was estimated with probit regression analysis. Results: ED95 varied greatly according to age and sex. ED95was 0.133 mg/kg, 0.181 mg/kg, 0.332 mg/kg, 0.183 mg/kg, 0.108 mg/kg, and 0.147 mg/kg in groups YM, OM, EM, YF, OF, and EF, respectively. Conclusion: ED95 is higher in males with increasing age but is ambiguous for females. ED95 is higher in males than in females over 40 years of age but is higher in females than in males under 41 years of age. However, after considering the age and sex of the study population, these results can be used as reference doses for further studies to verify the clinical effects of oxycodone for attenuating all IRHRs.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 197
Patients who are scheduled to undergo elective surgery under general anesthesia required endotracheal intubation.
Patients, aged between 20 to 80 years old, who were American Society of Anesthesiologists physical status I or II.
A. patients with refusal
B. patients with acute respiratory distress syndrome, cor pulmonae, acute asthma or other obstructive lung disease
C. cardiac arrhythmia
D. severe decreased renal function (creatine clearance < 10 mL/min)
E. moderate or severe hepatic failure
F. patients with brain tumor, impaired mental state, increased intracranial pressure
G. patients above 65 years old who can not agree to attend this study with voluntary participation
H. recent monoamine oxidase inhibitor (MAOI) taken patients
I. patients with complications on opioids or chronic medication
J. above 15 second of intubation time.
K. other participant in vulnerable environment except elderly patients
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method median effective dose (ED50) of intravenous oxycodone, which can attenuate or prevent 50% of hemodynamic changes by laryngoscopy and tracheal intubation.;95% effective dose (ED95) of intravenous oxycodone, which can attenuate or prevent 95% (ED95) of hemodynamic changes by laryngoscopy and tracheal intubation.
- Secondary Outcome Measures
Name Time Method Hemodynamic change [arterial blood pressure (systolic, diastolic, mean) and heart rate]