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Dexmedetomidine Infusion During Laparoscopic Adrenalectomy

Primary Purpose

Pheochromocytoma

Status

Completed

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

dexmedetomidine

0.9% normal saline

About this trial

This is an interventional supportive care trial for Pheochromocytoma

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Severance hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

dexmedetomidine group

Control group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

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

Intraoperative hemodynamic stability (duration of SBP exceeding 200 mmHg)

Intraoperative hemodynamic stability (maximum HR during surgery)

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

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

Secondary Outcome Measures

levels of catecholamines

the actual secretion levels of catecholamines, specifically epinephrine and norepinephrine, were measured at different time points

levels of catecholamines

the actual secretion levels of catecholamines, specifically epinephrine and norepinephrine, were measured at different time points

levels of catecholamines

the actual secretion levels of catecholamines, specifically epinephrine and norepinephrine, were measured at different time points

Full Information

NCT ID

NCT06037135

First Posted

August 8, 2023

Last Updated

October 3, 2023

Sponsor

Yonsei University

1. Study Identification

Unique Protocol Identification Number

NCT06037135

Brief Title

Dexmedetomidine Infusion During Laparoscopic Adrenalectomy

Official Title

The Effects of Perioperative Dexmedetomidine Infusion on Hemodynamic Stability During Laparoscopic Adrenalectomy for Pheochromocytoma: a Randomized Study

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Completed

Study Start Date

December 3, 2012 (Actual)

Primary Completion Date

March 26, 2021 (Actual)

Study Completion Date

March 26, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Yonsei University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pheochromocytoma

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

dexmedetomidine group

Arm Type

Experimental

Arm Description

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.

Arm Title

Control group

Arm Type

Active Comparator

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

dexmedetomidine

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

0.9% normal saline

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Time Frame

during operation

Title

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

Time Frame

during operation

Title

Intraoperative hemodynamic stability (duration of SBP exceeding 200 mmHg)

Time Frame

during operation

Title

Intraoperative hemodynamic stability (maximum HR during surgery)

Time Frame

during operation

Title

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

Time Frame

during operation

Title

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

Time Frame

during operation

Secondary Outcome Measure Information:

Title

levels of catecholamines

Description

the actual secretion levels of catecholamines, specifically epinephrine and norepinephrine, were measured at different time points

Time Frame

immediately after anesthesia induction

Title

levels of catecholamines

Description

the actual secretion levels of catecholamines, specifically epinephrine and norepinephrine, were measured at different time points

Time Frame

immediately after removal of the pheochromocytoma

Title

levels of catecholamines

Description

the actual secretion levels of catecholamines, specifically epinephrine and norepinephrine, were measured at different time points

Time Frame

immediately after the completion of surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Young Jun Oh, M.D., Ph.D.

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

Severance hospital

City

Seoul

Country

Korea, Republic of

12. IPD Sharing Statement

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Dexmedetomidine Infusion During Laparoscopic Adrenalectomy

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