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

NCT01839253 | Completed

• 1 other identifier: 4-2012-0422
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Orthognathic Surgery

Keywords

antihypertensive agents; hemodynamic; anesthetics reduction; orthognathic surgery

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (1)

• 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)

Study Arms (3)

Atenolol

EXPERIMENTAL

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

Drug: b-blocker(Atenolol)

Enalapril

ACTIVE COMPARATOR

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

Drug: ACE inhibitor(Enapril)

control

PLACEBO COMPARATOR

none of antihypertensive agents

Other: control

Interventions

b-blocker(Atenolol) DRUG

Atenolol

ACE inhibitor(Enapril) DRUG

Enalapril

control OTHER

control

Eligibility Criteria

• Age: 18 Years - 29 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Hypertension patients with anti-hypertensive agents
• chronic renal failure or End stage renal disease patients.
• renal artery stenosis history.
• Patients who are with medication due to systemic disease.
• symptomatic asthma
• Drug hyperactivity
• neurological or psychiatric illnesses
• mental retardation
• patients who can't read the consent form due to illiterate or foreigner

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

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

Seoul, Seoul, 120-752, South Korea

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2013
• First Posted: April 24, 2013
• Study Start: August 1, 2012
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: April 2, 2014

Record last verified: 2014-03

Locations

KR (1)