NCT06037135

Brief Summary

The investigators planned this study to investigate the effects of dexmedetomidine administration on intraoperative hemodynamic stability in patients with pheochromocytoma.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 3, 2012

Completed
8.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 26, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 26, 2021

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

August 8, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 14, 2023

Completed
Last Updated

October 6, 2023

Status Verified

October 1, 2023

Enrollment Period

8.3 years

First QC Date

August 8, 2023

Last Update Submit

October 3, 2023

Conditions

Pheochromocytoma

Outcome Measures

Primary Outcomes (6)

  • Intraoperative hemodynamic stability ( maximum blood pressure during surgery (systolic blood pressure (SBP), diastolic blood pressure (DBP), mean blood pressure (MBP))

    during operation

  • Intraoperative hemodynamic stability (duration of SBP increase by 30% or more from baseline (in minutes)

    during operation

  • Intraoperative hemodynamic stability (duration of SBP exceeding 200 mmHg)

    during operation

  • Intraoperative hemodynamic stability (maximum HR during surgery)

    during operation

  • Intraoperative hemodynamic stability (duration of HR exceeding 110 beats per minute during surgery)

    during operation

  • Intraoperative hemodynamic stability (comparison of the quantity of vasoactive drugs (nitroprusside, esmolol, norepinephrine) used during surgery)

    during operation

Secondary Outcomes (3)

  • levels of catecholamines

    immediately after anesthesia induction

  • levels of catecholamines

    immediately after removal of the pheochromocytoma

  • levels of catecholamines

    immediately after the completion of surgery

Study Arms (2)

dexmedetomidine group

EXPERIMENTAL

In the dexmedetomidine group, dexmedetomidine is administered at a rate of 0.5 μg/kg/h immediately after anesthesia induction and continued until the completion of the surgery.

Drug: dexmedetomidine

Control group

ACTIVE COMPARATOR

In the control group, a 0.9% normal saline infusion is initiated at the same rate immediately after anesthesia induction and continued until the end of the operation.

Drug: 0.9% normal saline

Interventions

dexmedetomidineDRUG

In the dexmedetomidine group, dexmedetomidine is administered at a rate of 0.5 μg/kg/h immediately after anesthesia induction and continued until the completion of the surgery. The research nurse, who did not participate in the study other than the management and preparation of the study medication, prepared 50mL of 0.9% normal saline for the control group and a mixture of dexmedetomidine 2 mL and 0.9% normal saline 48 mL (at a concentration of 4 μg/mL) for the dexmedetomidine group.

dexmedetomidine group
0.9% normal salineDRUG

In the control group, a 0.9% normal saline infusion is initiated at the same rate immediately after anesthesia induction and continued until the end of the operation.

Control group

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ages of 20 and 70
  • American Society of Anesthesiologists(ASA) physical status classification I to III,
  • planned laparoscopic adrenalectomy for pheochromocytoma.

You may not qualify if:

  • emergency operation,
  • re-operation,
  • combined surgery with other departments,
  • body mass index (BMI) \>32 kg/m2,
  • history of arrhythmias (especially AV nodal block) and ventricular conduction abnormalities,
  • uncontrolled hypertension (diastolic blood pressure \>110mmHg)
  • bradycardia (heart rate \< 40 beats per minute),
  • history of heart failure, hepatic and/or renal failure,
  • history of cerebrovascular disease (cerebral hemorrhage, cerebral ischemia),
  • history of beta-blocker therapy, 10) history of uncontrolled psychiatric disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Severance hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Pheochromocytoma

Interventions

DexmedetomidineSaline Solution

Condition Hierarchy (Ancestors)

ParagangliomaNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Young Jun Oh, M.D., Ph.D.

    Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 8, 2023

First Posted

September 14, 2023

Study Start

December 3, 2012

Primary Completion

March 26, 2021

Study Completion

March 26, 2021

Last Updated

October 6, 2023

Record last verified: 2023-10

Locations

KR(1)