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Intraoperative Hemodynamic Instability During Unilateral Adrenalectomy for Pheochromocytoma

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06062082
Acronym
HEMODADRE
Enrollment
60
Registered
2023-10-02
Start date
2015-09-01
Completion date
2024-09-01
Last updated
2025-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pheochromocytoma, Non-Secretory Adrenal Adenoma

Keywords

adrenalectomy

Brief summary

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).

Detailed 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).

Interventions

PROCEDUREadrenalectomy

laparoscopic exeresis of the adrenal gland

Sponsors

Central Hospital, Nancy, France
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Hemodynamic instability scoreduring 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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026