Clinical Trials Directory

Trials / Completed

CompletedNCT06062082

Intraoperative Hemodynamic Instability During Unilateral Adrenalectomy for Pheochromocytoma

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

Status
Completed
Phase
Study type
Observational
Enrollment
60 (actual)
Sponsor
Central Hospital, Nancy, France · Academic / Other
Sex
All
Age
18 Years – 80 Years
Healthy volunteers
Not accepted

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).

Conditions

Interventions

TypeNameDescription
PROCEDUREadrenalectomylaparoscopic exeresis of the adrenal gland

Timeline

Start date
2015-09-01
Primary completion
2019-08-31
Completion
2024-09-01
First posted
2023-10-02
Last updated
2025-02-13

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT06062082. Inclusion in this directory is not an endorsement.