Pheochromocytoma and Hemodynamic Instability

Hypertension Clinical Trial

Official title:

Risk Factors for Hemodynamic Instability During Laparoscopic Pheochromocytoma Resection - Single Centre Experience

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04566406
• Other study ID #: Pheochromocytoma&HI
• Status: Completed
• Start date: January 2003
• Est. completion date: September 2020

Study information

• Verified date: September 2020
• Source: Jagiellonian University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aims of our study were to define perioperative HI during laparoscopic adrenalectomy for pheochromocytoma, assess the incidence of perioperative HI, and identify predictive factors of perioperative HI in our group of patients.

Description:

The study was a retrospective observation of consecutive patients with histologically confirmed pheochromocytoma undergoing laparoscopic adrenalectomy between years 2003 and 2019.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: September 2020
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patients with histologically confirmed pheochromocytoma undergoing laparoscopic adrenalectomy

Exclusion Criteria:

• bilateral tumour

• no histopathological result

• neoplastic spread

Related Conditions & MeSH terms

• Hypertension
• Pheochromocytoma
• Surgery

Intervention

Procedure:
• Laparoscopic adrenalectomy
Preoperative staging in all cases consisted of computed tomography or/and magnetic resonance imaging. Prior to surgery, a routine panel of laboratory tests was carried out. The catecholamines metabolites (metanephrine, normetanephrine, and methoxytyramine) were measured from 24-hour urine collection. All patients were preoperatively treated with phenoxybenzamine or alternative doxazosin.Additionally, beta-blockers in case of coexisting tachycardia were given. In the morning of the operation, preinduction blood pressure was measured. Pneumoperitoneum was achieved by insufflating CO2 gas to an intraperitoneal pressure of 12 mmHg. The operative method in our department was laparoscopic transperitoneal lateral total adrenalectomy. Intraoperatively SBP and diastolic blood pressure (DBP) were measured and recorded every 10 minutes. To treat hypertensive and hypotensive episodes, intravenous doses of urapidil, ephedrine, nitrates, MgSO4, norepinephrine, or ß-blockers were administered.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Jagiellonian University

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Length of hospital stay (days)		Up to 30 days
Other	Duration of anaesthesia (min)		Intraoperative
Other	Duration of surgery (min)		Intraoperative
Other	Patients needing blood transfusion, n (%)		Intraoperative
Other	Mean intraoperative blood loss (ml)		Intraoperative
Other	Number of participants who required intraoperative vasodilators administration (n, %)		Intraoperative
Other	Number of participants who required intraoperative vasopressors administration (n, %)		Intraoperative
Other	Patients with episodes systolic blood pressure >200 mmHg (n, %)		Intraoperative
Other	Patients with episodes systolic blood pressure >180 mmHg (n, %)		Intraoperative
Other	Patients with episodes systolic blood pressure >160 mmHg (n, %)		Intraoperative
Other	Number of participants who required postoperative vasopressorss administration (n, %)		Within 24 hours after surgery
Primary	Number of Participants with Hemodynamic Instability (n, %)	Hemodynamic instability was defined as an occurrence of both intraoperative episodes of systolic blood pressure above 160 mm Hg and vasoactive (vasodilators or vasoconstrictors) drugs administration. Patients were divided into two groups: one which met both above criteria, and another one without hemodynamic instability.	intraoperative
Secondary	Number of Complications in Patients (n, %)	Data on morbidity were classified according to the Clavien-Dindo classification.	Within 30 days after surgery
Secondary	Number of Cardiovascular Complications in Patients (n, %)	Cardiovascular morbidity was defined as postoperative morbidity related to the cardiovascular system: postoperative hypotensive or hypertensive episodes requiring pharmacologic treatment, need for blood transfusion, myocardial or digestive ischemia, stroke, and postoperative hospitalization in intensive care unit (ICU) for cardiac-related causes.	Within 30 days after surgery