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

Not Applicable

Completed

• Conditions: Orthognathic Surgery
• Interventions: Drug: b-blocker(Atenolol); Drug: ACE inhibitor(Enapril); Other: control

• Registration Number: NCT01839253
• Lead Sponsor: Yonsei University

Brief Summary

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

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2013-04-17
• Study First Submitted QC: 2013-04-21
• Study First Posted: 2013-04-24
• Status Verified: 2014-03
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Last Update Submitted: 2014-03-31
• Last Update Posted: 2014-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Atenolol	b-blocker(Atenolol)	In each group, premedication with either b-blocker (Atenolol) or ACE inhibitor (enalapril) or nothing (control group) in the preparation room.
Enalapril	ACE inhibitor(Enapril)	In each group, premedication with either b-blocker (Atenolol) or ACE inhibitor (enalapril) or nothing (control group) in the preparation room.
control	control	none of antihypertensive agents

Primary Outcome Measures

Name	Time	Method
the influence of antihypertensive agents on hemodynamic stability	From the beginning until the end of hypoetensive anesthesiaan expected average of 65 mins.(From manipulration of Mandible to maxilla)	Total minutes when the MAP is lower than 55mmHg and higher than 65mmHg (min) , The time below 55 mmHg(min) , The total time above 65 mmHg (min) Total remifentanil amount, total NTG amount, total phenylephrine amount Arterial gas analysis 4 times after induction, at the start of manipulation of mandible, at the start of manipulation of maxilla, at the end of surgery.; Pr-operative and post-operative lab (Hb, Bun, Cr, OT, PT, Na, K) Intraoperative total fluid, total urine amount, total blood loss, transfusion amount.

Secondary Outcome Measures

Name	Time	Method
reduction of anaesthetics with control	From the beginning until the end of hypoetensive anesthesia an expected average of 65 mins.(From manipulration of Mandible to maxilla)	Total minutes when the MAP is lower than 55mmHg and higher than 65mmHg (min) , The time below 55 mmHg(min) , The total time above 65 mmHg (min) Total remifentanil amount, total NTG amount, total phenylephrine amount Arterial gas analysis 4 times after induction, at the start of manipulation of mandible, at the start of manipulation of maxilla, at the end of surgery.; Pr-operative and post-operative lab (Hb, Bun, Cr, OT, PT, Na, K) Intraoperative total fluid, total urine amount, total blood loss, transfusion amount.

Trial Locations

Locations (1)

Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine; 🇰🇷 Seoul, Korea, Republic of