Dexmedetomidine Infusion During Laparoscopic Adrenalectomy

NCT ID: NCT06037135

Last Updated: 2023-10-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-03

Study Completion Date

2021-03-26

Brief Summary

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

Detailed Description

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Conditions

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Pheochromocytoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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dexmedetomidine group

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.

Group Type EXPERIMENTAL

dexmedetomidine

Intervention Type DRUG

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.

Control group

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.

Group Type ACTIVE_COMPARATOR

0.9% normal saline

Intervention Type DRUG

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.

Interventions

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dexmedetomidine

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

0.9% normal saline

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

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Severance hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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4-2012-0577

Identifier Type: -

Identifier Source: org_study_id

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