Pheochromocytoma
Conditions
Brief summary
The investigators planned this study to investigate the effects of dexmedetomidine administration on intraoperative hemodynamic stability in patients with pheochromocytoma.
Interventions
DRUGdexmedetomidine
In the dexmedetomidine group, dexmedetomidine is administered at a rate of 0.5 μg/kg/h immediately after anesthesia induction and continued until the completion of the surgery. The research nurse, who did not participate in the study other than the management and preparation of the study medication, prepared 50mL of 0.9% normal saline for the control group and a mixture of dexmedetomidine 2 mL and 0.9% normal saline 48 mL (at a concentration of 4 μg/mL) for the dexmedetomidine group.
DRUG0.9% normal saline
In the control group, a 0.9% normal saline infusion is initiated at the same rate immediately after anesthesia induction and continued until the end of the operation.
Sponsors
Yonsei University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. ages of 20 and 70 2. American Society of Anesthesiologists(ASA) physical status classification I to III, 3. planned laparoscopic adrenalectomy for pheochromocytoma.
Exclusion criteria
1. emergency operation, 2. re-operation, 3. combined surgery with other departments, 4. body mass index (BMI) \>32 kg/m2, 5. history of arrhythmias (especially AV nodal block) and ventricular conduction abnormalities, 6. uncontrolled hypertension (diastolic blood pressure \>110mmHg) 7. bradycardia (heart rate \< 40 beats per minute), 8. history of heart failure, hepatic and/or renal failure, 9. history of cerebrovascular disease (cerebral hemorrhage, cerebral ischemia), 10. history of beta-blocker therapy, 10) history of uncontrolled psychiatric disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Intraoperative hemodynamic stability (duration of SBP exceeding 200 mmHg) | during operation |
| Intraoperative hemodynamic stability ( maximum blood pressure during surgery (systolic blood pressure (SBP), diastolic blood pressure (DBP), mean blood pressure (MBP)) | during operation |
| Intraoperative hemodynamic stability (duration of SBP increase by 30% or more from baseline (in minutes) | during operation |
| Intraoperative hemodynamic stability (comparison of the quantity of vasoactive drugs (nitroprusside, esmolol, norepinephrine) used during surgery) | during operation |
| Intraoperative hemodynamic stability (maximum HR during surgery) | during operation |
| Intraoperative hemodynamic stability (duration of HR exceeding 110 beats per minute during surgery) | during operation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| levels of catecholamines | immediately after anesthesia induction | the actual secretion levels of catecholamines, specifically epinephrine and norepinephrine, were measured at different time points |
Countries
South Korea
Outcome results
None listed