Intraoperative Hemodynamic Instability During Unilateral Adrenalectomy for Pheochromocytoma

Completed

• Conditions: Pheochromocytoma; Non-Secretory Adrenal Adenoma
• Interventions: Procedure: adrenalectomy

• Registration Number: NCT06062082
• Lead Sponsor: Central Hospital, Nancy, France

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).

Study Timeline

• Study Start: 2015-09-01
• Primary Completion: 2019-08-31
• Study First Submitted: 2022-07-06
• Study First Submitted QC: 2023-09-25
• Study First Posted: 2023-10-02
• Study Completion: 2024-09-01
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-11
• Last Update Posted: 2025-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control	adrenalectomy	Patients operated on for adrenal tumor other than pheochromocytoma by unilateral adrenalectomy
Pheochromocytoma	adrenalectomy	Patients operated on for pheochromocytoma by unilateral adrenalectomy

Primary Outcome Measures

Name	Time	Method
Hemodynamic instability score	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.

Trial Locations

Locations (1)

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