Clinical trial
The Effects of Perioperative Dexmedetomidine Infusion on Hemodynamic Stability During Laparoscopic Adrenalectomy for Pheochromocytoma: a Randomized Study
Name
4-2012-0577
Description
The investigators planned this study to investigate the effects of dexmedetomidine administration on intraoperative hemodynamic stability in patients with pheochromocytoma.
Trial arms
Trial start
2012-12-03
Estimated PCD
2021-03-26
Trial end
2021-03-26
Status
Completed
Treatment
dexmedetomidine
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.
Arms:
dexmedetomidine group
0.9% 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.
Arms:
Control group
Size
40
Primary endpoint
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 (duration of SBP exceeding 200 mmHg)
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
Intraoperative hemodynamic stability (comparison of the quantity of vasoactive drugs (nitroprusside, esmolol, norepinephrine) used during surgery)
during operation
Eligibility criteria
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'SUPPORTIVE_CARE', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 40, 'type': 'ACTUAL'}}
Updated at
2023-10-06
1 organization
2 products
1 indication
Organization
Yonsei UniversityProduct
dexmedetomidineIndication
PheochromocytomaProduct
0.9% normal saline