Non-invasive Evaluation of Fluid Status and Cardiac Output During Operative Treatment of Pheochromcytoma

Study Overview
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Brief Summary
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Non-invasive measurements of cardiac output (CO), systemic vascular resistance (SVR), corrected aortic flow time (FTc) and stroke volume (SV) are useful parameters during laparoscopic resection of pheochromocytoma (adrenalectomy) to document the intraoperative changes in volume status and to estimate the volume depletion.

Detailed Description
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Pheochromocytomas and extraadrenal paragangliomas are catecholamin-producing tumours deriving from the adrenal medulla and sympathetic ganglia. The only causal therapy is surgical resection. Nowadays, laparoscopic adrenalectomy is thought to be the optimal approach. Chronic volume depletion due to chronic hypertension and preoperative α-adrenoreceptor-blockade (to avoid the effects of intraoperative catecholamine-excess) often lead to hypotension after resection of the tumour. Volume reload with high amounts of fluid is often needed. Therefor some authors recommended invasive measurement (pulmonary artery catheter) to control cardiac output parameters and fluid balance. However, there are non-invasive methods to measure cardiac output(CO), systemic vascular resistance(SVR), stroke volume(SV) and corrected aortic flow time(FTc) to estimate volume status. Except transesophageal echocardiography, other techniques such as transoesophageal doppler and pulse pressure methods exist but have not been investigated during surgical therapy for pheochromocytoma so far. The esophageal Doppler currently represents the gold standard for perioperative fluid replacement therapy. The study's hypothesis is that non-invasive measurements of cardiac output (CO), systemic vascular resistance (SVR), corrected aortic flow time (FTc) and stroke volume (SV) are useful parameters during laparoscopic resection of pheochromocytoma (adrenalectomy) to document the intraoperative changes in volume status and to estimate the volume depletion.

Official Title
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Non-invasive Evaluation of Fluid Status and Cardiac Output During Operative Treatment of Pheochromcytoma

Conditions
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Pheochromocytoma

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Planned laparoscopic adrenalectomy for pheochromocytoma (Biochemical confirmed adrenal and extraadrenal pheochromocytoma) Planned laparoscopic adrenalectomy for hormonally inactive adrenal tumor Exclusion Criteria: Risk of esophageal bleeding or perforation exists (i.e., liver disease with portal hypertension and/or esophageal varicoses, other esophageal anomalies).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pheochromocytoma Group<br>Intraoperative esophageal doppler sonography during laparoscopic adrenalectomy performed for pheochromocytoma | |
| Control group<br>Intraoperative esophageal doppler sonography during laparoscopic adrenalectomy for non-pheochromocytoma adrenal tumor | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac output (CO) | measured using esophageal doppler | parameter will be measured continously for the duration of adrenalectomy, an expected average of 3 hours | 
| Systemic vascular resistance (SVR) | measured using esophageal doppler | parameter will be measured continously for the duration of adrenalectomy, an expected average of 3 hours | 
| Stroke volume (SV) | measured using esophageal doppler | parameter will be measured continously for the duration of adrenalectomy, an expected average of 3 hours | 
| Corrected aortic flow time(FTc) | measured using esophageal doppler | parameter will be measured continously for the duration of adrenalectomy, an expected average of 3 hours | 
| Central venous pressure | Measured using esophageal doppler | parameter will be measured continously for the duration of adrenalectomy, an expected average of 3 hours | 
| Heart rate |  | parameter will be measured continously for the duration of adrenalectomy, an expected average of 3 hours | 
| Arterial blood pressure | systolic, diastolic, mean; continuous invasive measurement | parameter will be measured continously for the duration of adrenalectomy, an expected average of 3 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in serum Concentration: Epinephrine |  | 7 timepoints during anesthesia (Administration of rocuronium, intubation, cut, intraabdominal air insufflation, ligature of v. suprarenalis, tumor exstirpation, end of operation) | 
| Changes in serum concentration: Norepinephrine |  | 7 timepoints during anesthesia (Administration of rocuronium, intubation, cut, intraabdominal air insufflation, ligature of v. suprarenalis, tumor exstirpation, end of operation) | 
| Changes in serum concentration: Dopamin |  | 7 timepoints during anesthesia (Administration of rocuronium, intubation, cut, intraabdominal air insufflation, ligature of v. suprarenalis, tumor exstirpation, end of operation) | 
| Changes in plasma concentration: Metanephrines |  | 7 timepoints during anesthesia (Administration of rocuronium, intubation, cut, intraabdominal air insufflation, ligature of v. suprarenalis, tumor exstirpation, end of operation) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adrenalectomy, Pheochromocytoma, Cardiac output, Fluid managment, Esopagheal doppler sonography