Dexmedetomidine Infusion During Laparoscopic Adrenalectomy

Study Overview
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Brief Summary
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The investigators planned this study to investigate the effects of dexmedetomidine administration on intraoperative hemodynamic stability in patients with pheochromocytoma.

Official Title
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The Effects of Perioperative Dexmedetomidine Infusion on Hemodynamic Stability During Laparoscopic Adrenalectomy for Pheochromocytoma: a Randomized Study

Conditions
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Pheochromocytoma

Intervention / Treatment
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* Drug: dexmedetomidine
* Drug: 0.9% normal saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ages of 20 and 70 American Society of Anesthesiologists(ASA) physical status classification I to III, planned laparoscopic adrenalectomy for pheochromocytoma. Exclusion Criteria: emergency operation, re-operation, combined surgery with other departments, body mass index (BMI) >32 kg/m2, history of arrhythmias (especially AV nodal block) and ventricular conduction abnormalities, uncontrolled hypertension (diastolic blood pressure >110mmHg) bradycardia (heart rate < 40 beats per minute), history of heart failure, hepatic and/or renal failure, history of cerebrovascular disease (cerebral hemorrhage, cerebral ischemia), history of beta-blocker therapy, 10) history of uncontrolled psychiatric disease.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: dexmedetomidine group<br>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. | Drug: dexmedetomidine<br>* 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.<br>|
| Active Comparator: Control group<br>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. | Drug: 0.9% normal saline<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| levels of catecholamines | the actual secretion levels of catecholamines, specifically epinephrine and norepinephrine, were measured at different time points | immediately after anesthesia induction | 
| levels of catecholamines | the actual secretion levels of catecholamines, specifically epinephrine and norepinephrine, were measured at different time points | immediately after removal of the pheochromocytoma | 
| levels of catecholamines | the actual secretion levels of catecholamines, specifically epinephrine and norepinephrine, were measured at different time points | immediately after the completion of surgery |