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The Effect of Deliberate Hypotension on QTc, Tp-e Intervals and Heart Rate Variability

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01634594
Recruitment Status : Completed
First Posted : July 6, 2012
Last Update Posted : March 19, 2019
Sponsor:
Information provided by (Responsible Party):
Yonsei University

Study Description
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Brief Summary:
Deliberate hypotension is defined as lowering the systolic blood pressure to 80-90mmHg, or the mean blood pressure to 50-65mmHg. This technique is usually employed for operations that have a high risk of intraoperative hemorrhage, such as orthognathic surgery. Several different regimens are used to lower the patient's blood pressure, such as vasodilators, autonomic nervous system inhibitors, opioids and inhalation anesthetics. However, the effects that these agents have on the QTc and Tp-e intervals during deliberate hypotension is not known. Virtually every kind of anesthetic is reported to have some effect on the QTc and Tp-e intervals. Because orthognathic surgery usually takes 3-4 hours to complete, the amount of anesthetics and drugs used to maintain low blood pressure is not small. Therefore, the effect that these agents may have on the QTc and Tp-e intervals may not be negligible. The investigators of the present study found that the high dose of commonly used hypotensive agents tend to prolong these variabilities to some extent. This study will be able to provide insight as to which hypotensive anesthesia regimen has the least effect on the QTc and Tp-e intervals, and therefore will be helpful in minimizing cardiovascular risks of deliberate hypotensive anesthesia.

Condition or disease Intervention/treatment Phase
Mandibular Prognathism Mandibular Retrognathism Drug: Group R Drug: Group N Drug: Group D Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Study Start Date : June 2012
Actual Primary Completion Date : February 2013
Actual Study Completion Date : February 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Sevoflurane

Arms and Interventions
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Arm Intervention/treatment
Experimental: sevoflurane-remifentanil (group R)
Continuous infusion of remifentanil at 0.05 ~ 2 mcg/kg/min with sevoflurane concentration of 1 MAC
 Drug: Group R
Other Name: Continuous infusion of remifentanil at 0.05 ~ 2 mcg/kg/min with sevoflurane concentration of 1 MAC
Active Comparator: sevoflurane-nicardipine (group N)
Continuous infusion of nicardipine at 1 ~ 7 mcg/kg/min with sevoflurane concentration of 1 MAC
 Drug: Group N
Other Name: Continuous infusion of nicardipine at 1 ~ 7 mcg/kg/min with sevoflurane concentration of 1 MAC
Active Comparator: sevoflurane-dexmedetomidine (group D)
Continuous infusion of dexmedetomidine at 0.2 ~ 1.0 mcg/kg/hr with sevoflurane concentration of 1 MAC
 Drug: Group D
Other Name: Continuous infustion of dexmedetomidine at 0.2 ~ 1.0 mcg/kg/hr with sevoflurane concentration of 1 MAC


Outcome Measures
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Primary Outcome Measures :
  1. Changes in QTc, Tp-e interval during deliberate hypotension [ Time Frame: Before induction of anesthesia (T1), 10 minutes after induction of anesthesia (T2), 30 minutes after target blood pressure is reached (T3), every 60 minutes after from the end of surgery ]

Secondary Outcome Measures :
  1. Changes in Tp-e interval during deliberate hypotension [ Time Frame: Before induction of anesthesia (T1), 10 minutes after induction of anesthesia (T2), 30 minutes after target blood pressure is reached (T3), every 60 minutes after from the end of surgery ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. ASA class 1
  2. Adults over the age of 20
  3. Patients requiring deliberate hypotensive anesthesia for orthognathic surgery

Exclusion Criteria:

  1. Patient refusal
  2. Patients with arrhythmia
  3. Patients with cardiac anomalies or past history of cardiac surgery
  4. Patients with abnormal electrolyte levels
  5. Patients taking medications that are known to prolong QT intervals
  6. Patients with QTc intervals greater than 440ms
  7. Illiterate patients
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01634594


Locations
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Korea, Republic of
Young Jun Oh
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Yonsei University
More Information
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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01634594    
Other Study ID Numbers: 4-2012-0242
First Posted: July 6, 2012    Key Record Dates
Last Update Posted: March 19, 2019
Last Verified: March 2019
Keywords provided by Yonsei University:
Deliberate hypotension, QTc, Tp-e, heart rate variability
Additional relevant MeSH terms:
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Prognathism
Retrognathia
Malocclusion, Angle Class III
Jaw Abnormalities
Jaw Diseases
Musculoskeletal Diseases
Mandibular Diseases
Maxillofacial Abnormalities
Craniofacial Abnormalities
Musculoskeletal Abnormalities
Stomatognathic Diseases
Stomatognathic System Abnormalities
Congenital Abnormalities
Malocclusion
Tooth Diseases
 Nicardipine
Dexmedetomidine
Remifentanil
Sevoflurane
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents