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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yonsei University
ClinicalTrials.gov Identifier:
NCT01839253
First received: April 17, 2013
Last updated: March 31, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Orthognathic Surgery
Drug: b-blocker(Atenolol)
Drug: ACE inhibitor(Enapril)
Other: control

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

Resource links provided by NLM:


Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • the influence of antihypertensive agents on hemodynamic stability [ Time Frame: From the beginning until the end of hypoetensive anesthesiaan expected average of 65 mins.(From manipulration of Mandible to maxilla) ] [ Designated as safety issue: No ]

    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:
  • reduction of anaesthetics with control [ Time Frame: From the beginning until the end of hypoetensive anesthesia an expected average of 65 mins.(From manipulration of Mandible to maxilla) ] [ Designated as safety issue: No ]

    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.



Enrollment: 75
Study Start Date: August 2012
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Atenolol
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)
Active Comparator: Enalapril
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)
Placebo Comparator: control
none of antihypertensive agents
Other: control

  Eligibility

Ages Eligible for Study:   18 Years to 29 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01839253

Locations
Korea, Republic of
Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Yonsei University
  More Information

No publications provided

Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01839253     History of Changes
Other Study ID Numbers: 4-2012-0422
Study First Received: April 17, 2013
Last Updated: March 31, 2014
Health Authority: Korea: Institutional Review Board

Keywords provided by Yonsei University:
antihypertensive agents
hemodynamic
anesthetics reduction
orthognathic surgery

Additional relevant MeSH terms:
Anesthetics
Atenolol
Antihypertensive Agents
Angiotensin-Converting Enzyme Inhibitors
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Protease Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 29, 2014