Effect of Local Anesthetic on Hemodynamic Measures During Nasal Surgery



Status:Completed
Conditions:High Blood Pressure (Hypertension)
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:16 - 75
Updated:5/3/2014
Start Date:November 2012
End Date:February 2014
Contact:Kristin A Seiberling, MD
Email:kseiberling@llu.edu
Phone:909 558 7884

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1% Lidocaine with 1:100,000 to 1:200,000 of epinephrine is routinely injected into the nasal
mucosa during nasal surgery to reduce patient blood loss and improve the surgical field and
visibility. Typically 1% lidocaine with 1:100,000 of epinephrine is used in nasal surgery.
However, 1 % lidocaine with 1:200,000 (which is a more dilute solution of epinephrine) is
also used. This latter dose theoretically should have a lesser effect on cardiac
stimulation which increases the heart rate and blood pressure at the time of surgery. The
nasal mucosa has excellent absorbing ability which is great for the application of drugs but
there is concern for systemic absorption and side effects. Potential serious side effects
can occur with local injection such as hypertension, tachycardia, and cardiac arrhythmias.
These side effects occur mainly through the absorption of epinephrine. It is the goal of
this study to see if a weaker concentration of epinephrine (1:200,000) can maintain a good
surgical field with a decrease in hemodynamic side effects.

Objective- To evaluate the effect of 1% lidocaine with 1:200,000 of epinephrine on
hemodynamic measures and bleeding in the surgical field in patients undergoing nasal surgery
compared to 1% lidocaine with 1:100,000.

Recruitment plan- Patients undergoing general anesthetic for nasal surgery (septoplasty or
sinus surgery) will be asked to participate in this study. All patients undergoing nasal
surgery are injected with local anesthetic into the nasal mucosa after induction of general
anesthetic. Those patients who agree to participate in the study will be randomized into 2
groups (injection either 1 % lidocaine with 1:100,000 or 1:200,000 of epinephrine).

Procedures

1. Patients will be put to sleep following standard general anesthetic protocol

2. Patients will be injected with either 1% lidocaine with 1:100,000 or 1% lidocaine with
1:200,000 into the nasal mucosa

3. After injection the following will be measured every 15 minutes for the first hour to
evaluate effectiveness of the local anesthetic.

1. Heart rate

2. Blood pressure

3. Routine ECG monitoring

4. MAP (mean arterial pressure)

5. Surgical field, degree of bleeding.

Alternatives- Subjects can refuse to participate in the study. If subjects refuse to
participate in the study they will still be injected with 1% lidocaine with 1:200,000 of
epinephrine which is standard of care

Data analysis- data will be compiled and statistical analysis will be made using PRISM
software.

Inclusion Criteria:

- any patient between the ages of 16-75 who is scheduled to undergo routine nasal
surgery.

Exclusion Criteria:

- allergy to lidocaine,

- recent MI,

- recent stroke,

- uncontrolled hypertension,

- arrhythmias,

- congestive heart failure.
We found this trial at
1
site
11234 Anderson St
Loma Linda, California 92354
(909) 558-4000
Loma Linda University Medical Center An outgrowth of the original Sanitarium on the hill in...
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mi
from
Loma Linda, CA
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