The Effect of Antihypertensive Agents Concerning With Hemodynamics and Reduction of Anaesthetics in Orthognathic Surgery

NCT ID: NCT01839253

Last Updated: 2014-04-02

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

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2014-03-31

Brief Summary

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For those who receive hypotensive anesthesia in orthognathic surgeries, the investigators premedicate with anti-hypertensive agent so that it decreases the occurence of tachycardia and the rebound hypertension due to hypotensive anesthesia, enabling us to compare hemodynamic stability and reduction of anesthetic agents during the operation.

Detailed Description

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Conditions

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Orthognathic Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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Atenolol

In each group, premedication with either b-blocker (Atenolol) or ACE inhibitor (enalapril) or nothing (control group) in the preparation room.

Group Type EXPERIMENTAL

b-blocker(Atenolol)

Intervention Type DRUG

Enalapril

In each group, premedication with either b-blocker (Atenolol) or ACE inhibitor (enalapril) or nothing (control group) in the preparation room.

Group Type ACTIVE_COMPARATOR

ACE inhibitor(Enapril)

Intervention Type DRUG

control

none of antihypertensive agents

Group Type PLACEBO_COMPARATOR

control

Intervention Type OTHER

Interventions

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b-blocker(Atenolol)

Intervention Type DRUG

ACE inhibitor(Enapril)

Intervention Type DRUG

control

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. ASA class I-II
2. obtaining written informed consent from the parents
3. aged 18-29 years who were undergoing orthognathic surgery.

Exclusion Criteria

1. Hypertension patients with anti-hypertensive agents
2. chronic renal failure or End stage renal disease patients.
3. renal artery stenosis history.
4. Patients who are with medication due to systemic disease.
5. symptomatic asthma
6. Drug hyperactivity
7. neurological or psychiatric illnesses
8. mental retardation
9. patients who can't read the consent form due to illiterate or foreigner
Minimum Eligible Age

18 Years

Maximum Eligible Age

29 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

Locations

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

Seoul, Seoul, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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4-2012-0422

Identifier Type: -

Identifier Source: org_study_id

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