Magnesium and Dexmedetomidine in Pheochromocytoma

October 20, 2021 updated by: Nukhet Sivrikoz, Istanbul University

Magnesium and Dexmedetomidine Combination Reduces Sodium Nitroprusside Requirement in Laparoscopic Pheochromocytoma

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

108

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Received oral 300 mg magnesium one week before surgery and magnesium-dexmedetomidine combination perioperatively

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul University

Investigators

  • Principal Investigator: Nükhet Sivrikoz, MD, Attending anesthesiologist

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2011

Primary Completion (ACTUAL)

March 1, 2020

Study Completion (ACTUAL)

March 1, 2020

Study Registration Dates

First Submitted

October 20, 2021

First Submitted That Met QC Criteria

October 20, 2021

First Posted (ACTUAL)

November 1, 2021

Study Record Updates

Last Update Posted (ACTUAL)

November 1, 2021

Last Update Submitted That Met QC Criteria

October 20, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021/42

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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