Magnesium and Dexmedetomidine in Pheochromocytoma | NCT05102058

Studies
Magnesium and Dexmedetomidine in Pheochromocytoma

NCT05102058

Sponsor

Istanbul University

Status

Completed

Last Update Posted

Nov 1, 2021Actual

Enrollment

108Actual

Phase

Not provided

Conditions

Phaeochromocytoma Crisis
Hemodynamic Instability

Interventions

Magnesium-Dexmedetomidine

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2011Actual

Primary Completion Date

Mar 1, 2020Actual

Completion Date

Mar 1, 2020Actual

First Submitted Date

Oct 20, 2021

First Submission Date that Met QC Criteria

Oct 20, 2021

First Posted Date

Nov 1, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 20, 2021

Last Update Posted Date

Nov 1, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Anesthesia management of pheochromocytoma excision surgery is associated with severe hemodynamic fluctuations.The objective of this study was to compare the hypertensive episodes requiring sodium nitroprusside administration between the group treated with magnesium-dexmedetomidine and conventional group in pheochromocytoma.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

108Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Conventional group (GC)		Not receive perioperative additional medication.
Magnesium-dexmedetomidine therapy group (GMD)		Received oral 300 mg magnesium one week before surgery and magnesium-dexmedetomidine combination perioperatively.	Drug: Magnesium-Dexmedetomidine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Magnesium-Dexmedetomidine	Drug	Received oral 300 mg magnesium one week before surgery and magnesium-dexmedetomidine combination perioperatively	Magnesium-dexmedetomidine therapy group (GMD)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Sodium nitroprusside (SNP) requirement	intraoperative hypertensive episodes requiring SNP therapy	intraoperative period

Secondary Outcomes

Measure	Description	Time Frame
vasoactive therapy	hemodynamic fluctuations (hypotension, tachycardia, severe hypertensive crisis) which needed vasoactive therapy.	intraoperative period

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

American Society of Anesthesiologists classification (ASA) 1-3
high urinary catecholamine or metabolites
tumor sizes < 5 cm
body mass index (BMI) <35 kg/m2

Exclusion Criteria:

open surgery
bilateral masses
tumor larger than 5 cm
incomplete data

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Patients' data who were aged 18-75, had the American Society of Anesthesiologists classification (ASA) 1-3 and high urinary catecholamine or metabolites. Patients with tumor sizes < 5 cm and body mass index (BMI) <35 kg.m-2 were examined, who were evaluated according to Endocrine Society Practice Guideline and provided the Roizen criteria.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Nükhet Sivrikoz, MD	Attending anesthesiologist	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010673	Pheochromocytoma

Ancestor Terms

ID	Term
D010235	Paraganglioma
D018358	Neuroendocrine Tumors
D017599	Neuroectodermal Tumors
D009373	Neoplasms, Germ Cell and Embryonal

Browse Leaves

Not provided

Browse Branches

Not provided