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

Orthognathic Surgery Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01839253
• Other study ID #: 4-2012-0422
• Status: Completed
• Phase: N/A
• First received: April 17, 2013
• Last updated: March 31, 2014
• Start date: August 2012
• Est. completion date: March 2014

Study information

• Verified date: March 2014
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 29 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Orthognathic Surgery

Intervention

Drug:
• b-blocker(Atenolol)

• ACE inhibitor(Enapril)

Other:
• control

Locations

Country	Name	City	State
Korea, Republic of	Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the influence of antihypertensive agents on hemodynamic stability	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.	From the beginning until the end of hypoetensive anesthesiaan expected average of 65 mins.(From manipulration of Mandible to maxilla)	No
Secondary	reduction of anaesthetics with control	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.	From the beginning until the end of hypoetensive anesthesia an expected average of 65 mins.(From manipulration of Mandible to maxilla)	No