The Effect of Deliberate Hypotension on QTc, Tp-e Intervals and Heart Rate Variability
Information source: Yonsei University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Mandibular Prognathism,; Mandibular Retrognathism
Intervention: Group R (Drug); Group N (Drug); Group D (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Yonsei University
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.
Clinical Details
Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Primary outcome: Changes in QTc, Tp-e interval during deliberate hypotension
Secondary outcome: Changes in Tp-e interval during deliberate hypotension
Eligibility
Minimum age: 20 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Young Jun Oh, Seoul 120-752, Korea, Republic of
Additional Information
Starting date: June 2012
Last updated: February 13, 2013
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