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Intraoperative Hemodynamic Instability During Unilateral Adrenalectomy for Pheochromocytoma (HEMODADRE)

C

Central Hospital, Nancy, France

Status

Completed

Conditions

Non-Secretory Adrenal Adenoma
Pheochromocytoma

Treatments

Procedure: adrenalectomy

Study type

Observational

Funder types

Other

Identifiers

NCT06062082
reference 2020PI123

Details and patient eligibility

About

Pheochromocytomas are tumors of the adrenal gland that develop from cells producing adrenaline and noradrenaline. Consequently, intraoperative blood pressure variations (hypertensive and hypotensive episodes) are characteristic of pheochromocytoma surgery, when these tumors are removed. However, recommendations for the management of these tumors are based on data essentially dating from the 1960s-1990s. Since then, anesthesia and surgery for patients with pheochromocytoma have evolved considerably, and have become more effective with time. In these circumstances, a review of the current situation is necessary. The aim of this study is to investigate the intraoperative hemodynamic changes observed in patients undergoing adrenalectomy for pheochromocytoma, comparing them with the hemodynamic profile observed in patients undergoing adrenal surgery for a pathology other than pheochromocytoma (control group).

Full description

Each patient included in this study underwent unilateral adrenalectomy for adrenal pathology during the inclusion period. For each patient included, intraoperative hemodynamic data were collected every 20 seconds by the monitoring system used by the anesthesia team (VitalSignsCapture v1.004 program via RS232 port). For each patient, the HI score (a clinical tool validated in two previously published articles) was calculated for the intraoperative period (time between induction of anesthesia and patient discharge from the operating room). This enabled a comparison to be made between patients operated on for pheochromocytoma (30 patients) and patients operated on for a cause other than pheochromocytoma (30 patients).

Enrollment

60 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients operated on for unilateral adrenal pathology by laparosocopic approach (pheochromocytoma and non-pheochromocytoma)

Exclusion criteria

  • Patients operated on for unilateral adrenal pathology by laparosocopic approach (pheochromocytoma and non-pheochromocytoma)
  • Patients operated on for bilateral adrenal pathology

Trial design

60 participants in 2 patient groups

Pheochromocytoma
Description:
Patients operated on for pheochromocytoma by unilateral adrenalectomy
Treatment:
Procedure: adrenalectomy
Control
Description:
Patients operated on for adrenal tumor other than pheochromocytoma by unilateral adrenalectomy
Treatment:
Procedure: adrenalectomy

Trial contacts and locations

1

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Central trial contact

Phi Linh Nguyen; Laurent Brunaud

Data sourced from clinicaltrials.gov

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