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

NCT01634594 | Completed Phase 4

• 1 other identifier: 4-2012-0242
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Mandibular Prognathism; Mandibular Retrognathism

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Changes in QTc, Tp-e interval during deliberate hypotension

  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 Outcomes (1)

• Changes in Tp-e interval during deliberate hypotension

  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

Study Arms (3)

sevoflurane-remifentanil (group R)

EXPERIMENTAL

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

Drug: Group R

sevoflurane-nicardipine (group N)

ACTIVE COMPARATOR

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

Drug: Group N

sevoflurane-dexmedetomidine (group D)

ACTIVE COMPARATOR

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

Drug: Group D

Interventions

Group R DRUG

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

sevoflurane-remifentanil (group R)

Group N DRUG

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

sevoflurane-nicardipine (group N)

Group D DRUG

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

sevoflurane-dexmedetomidine (group D)

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Young Jun Oh

Seoul, 120-752, South Korea

Location

MeSH Terms

Conditions

Malocclusion, Angle Class III

Condition Hierarchy (Ancestors)

Malocclusion; Tooth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2012
• First Posted: July 6, 2012
• Study Start: June 1, 2012
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: March 19, 2019

Record last verified: 2019-03

Locations

KR (1)