Intraoperative Hemodynamic Instability During Unilateral Adrenalectomy for Pheochromocytoma

Pheochromocytoma Clinical Trial

— HEMODADRE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06062082
• Other study ID #: reference 2020PI123
• Status: Recruiting
• Start date: September 1, 2015
• Est. completion date: September 1, 2024

Study information

• Verified date: September 2023
• Source: Central Hospital, Nancy, France
• Contact: Laurent Brunaud
• Email: l.brunaud[@]chru-nancy.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: September 1, 2024
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Adenoma
• Adrenocortical Adenoma
• Pheochromocytoma

Intervention

Procedure:
• adrenalectomy
laparoscopic exeresis of the adrenal gland

Locations

Country	Name	City	State
France	CHRU Nancy - Département Chirurgie Viscérale, Métabolique et Cancérologique CVMC (7ème étage)	Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

References & Publications (2)

Buitenwerf E, Boekel MF, van der Velde MI, Voogd MF, Kerstens MN, Wietasch GJKG, Scheeren TWL. The haemodynamic instability score: Development and internal validation of a new rating method of intra-operative haemodynamic instability. Eur J Anaesthesiol. — View Citation

Buitenwerf E, Osinga TE, Timmers HJLM, Lenders JWM, Feelders RA, Eekhoff EMW, Haak HR, Corssmit EPM, Bisschop PHLT, Valk GD, Veldman RG, Dullaart RPF, Links TP, Voogd MF, Wietasch GJKG, Kerstens MN. Efficacy of alpha-Blockers on Hemodynamic Control during — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemodynamic instability score	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.	during surgery (from induction of the patient under general anesthesia to discharge from the operating room)