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

Primary Purpose

Mandibular Prognathism, Mandibular Retrognathism

Status

Completed

Phase

Phase 4

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Group R

Group N

Group D

About this trial

This is an interventional prevention trial for Mandibular Prognathism focused on measuring Deliberate hypotension, QTc, Tp-e, heart rate variability

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

Patient refusal
Patients with arrhythmia
Patients with cardiac anomalies or past history of cardiac surgery
Patients with abnormal electrolyte levels
Patients taking medications that are known to prolong QT intervals
Patients with QTc intervals greater than 440ms
Illiterate patients

Sites / Locations

Young Jun Oh

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

sevoflurane-remifentanil (group R)

sevoflurane-nicardipine (group N)

sevoflurane-dexmedetomidine (group D)

Arm Description

Continuous infusion of remifentanil at 0.05 ~ 2 mcg/kg/min with sevoflurane concentration of 1 MAC

Continuous infusion of nicardipine at 1 ~ 7 mcg/kg/min with sevoflurane concentration of 1 MAC

Continuous infusion of dexmedetomidine at 0.2 ~ 1.0 mcg/kg/hr with sevoflurane concentration of 1 MAC

Outcomes

Primary Outcome Measures

Changes in QTc, Tp-e interval during deliberate hypotension

Secondary Outcome Measures

Changes in Tp-e interval during deliberate hypotension

Full Information

NCT ID

NCT01634594

First Posted

June 25, 2012

Last Updated

March 15, 2019

Sponsor

Yonsei University

1. Study Identification

Unique Protocol Identification Number

NCT01634594

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2019

Overall Recruitment Status

Completed

Study Start Date

June 2012 (undefined)

Primary Completion Date

February 2013 (Actual)

Study Completion Date

February 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Yonsei University

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Mandibular Prognathism, Mandibular Retrognathism

Keywords

Deliberate hypotension, QTc, Tp-e, heart rate variability

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

66 (Actual)

8. Arms, Groups, and Interventions

Arm Title

sevoflurane-remifentanil (group R)

Arm Type

Experimental

Arm Description

Continuous infusion of remifentanil at 0.05 ~ 2 mcg/kg/min with sevoflurane concentration of 1 MAC

Arm Title

sevoflurane-nicardipine (group N)

Arm Type

Active Comparator

Arm Description

Continuous infusion of nicardipine at 1 ~ 7 mcg/kg/min with sevoflurane concentration of 1 MAC

Arm Title

sevoflurane-dexmedetomidine (group D)

Arm Type

Active Comparator

Arm Description

Continuous infusion of dexmedetomidine at 0.2 ~ 1.0 mcg/kg/hr with sevoflurane concentration of 1 MAC

Intervention Type

Drug

Intervention Name(s)

Group R

Other Intervention Name(s)

Continuous infusion of remifentanil at 0.05 ~ 2 mcg/kg/min with sevoflurane concentration of 1 MAC

Intervention Type

Drug

Intervention Name(s)

Group N

Other Intervention Name(s)

Continuous infusion of nicardipine at 1 ~ 7 mcg/kg/min with sevoflurane concentration of 1 MAC

Intervention Type

Drug

Intervention Name(s)

Group D

Other Intervention Name(s)

Continuous infustion of dexmedetomidine at 0.2 ~ 1.0 mcg/kg/hr with sevoflurane concentration of 1 MAC

Primary Outcome Measure Information:

Title

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 Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: ASA class 1 Adults over the age of 20 Patients requiring deliberate hypotensive anesthesia for orthognathic surgery Exclusion Criteria: Patient refusal Patients with arrhythmia Patients with cardiac anomalies or past history of cardiac surgery Patients with abnormal electrolyte levels Patients taking medications that are known to prolong QT intervals Patients with QTc intervals greater than 440ms Illiterate patients

Facility Information:

Facility Name

Young Jun Oh

City

Seoul

ZIP/Postal Code

120-752

Country

Korea, Republic of

12. IPD Sharing Statement

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

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