Intraoperative Hemodynamic Instability During Unilateral Adrenalectomy for Pheochromocytoma

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).

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Key information

Conditions

Pheochromocytoma Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Non-Secretory Adrenal Adenoma Paraganglioma

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

CHRU Nancy - Département Chirurgie Viscérale, Métabolique et Cancérologique CVMC (7ème étage)

Nancy, 54511, France

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Adrenalectomy

Procedure

laparoscopic exeresis of the adrenal gland

Primary outcomes

Hemodynamic instability score

Time frame: during surgery (from induction of the patient under general anesthesia to discharge from the operating room)

The haemodynamic instability score was calculated as a weighted continuous measure ranging from 0 to 160 points. This score appropriately quantifies deviations of blood pressure and heart rate from predefined thresholds, and infusion rates of vasoactive agents and fluids. Zero corresponds to the absence of peroperative hemodynamic changes and 160 to the maximum possible peroperative hemodynamic changes.

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Official study title

What is Intraoperative Hemodynamic Instability During Unilateral Adrenalectomy for Pheochromocytoma: an Observational Study

Acronym: HEMODADRE

Important dates

Study start: 2015
Primary completion: 2019
Study completion: 2024
First posted: Oct 2, 2023
Registry last updated: Feb 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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