Effect of Local Anesthetic on Hemodynamic Measures During Nasal Surgery

This study has been withdrawn prior to enrollment.

(no time)

Sponsor:

Information provided by (Responsible Party):

Kristin Seiberling, MD, Loma Linda University

ClinicalTrials.gov Identifier:

NCT01701960

First received: October 3, 2012

Last updated: December 3, 2014

Last verified: December 2014

History of Changes

Purpose

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.

Condition
Heart Rate Blood Pressure Blood Loss During Surgery Surgical Field


Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Effect of Local Anesthetic on Hemodynamic Measures During Nasal Surgery

Further study details as provided by Loma Linda University:

Primary Outcome Measures:

change in blood pressure [ Time Frame: over the course of surgery ] [ Designated as safety issue: No ]


Enrollment:	0
Study Start Date:	November 2012
Study Completion Date:	August 2014
Estimated Primary Completion Date:	February 2014 (Final data collection date for primary outcome measure)

Groups/Cohorts
Group 1 This cohort will be injected with 1% lidocaine with 1:100,000 of epinephrine into the nasal mucosa at the time of nasal surgery
Group 2 This group will be injected with 1% lidocaine with 1:200,000 of epinephrine into the nasal mucosa at the start of nasal surgery.

Detailed Description:

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

Patients will be put to sleep following standard general anesthetic protocol
Patients will be injected with either 1% lidocaine with 1:100,000 or 1% lidocaine with 1:200,000 into the nasal mucosa
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.

Eligibility


Ages Eligible for Study:	16 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Subjects ages 16-75 undergoing routine nasal surgery which will include septoplasty and sinus surgery

Criteria

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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01701960

Locations


United States, California
Loma Linda University Medical Center
Loma Linda, California, United States, 92354

Sponsors and Collaborators

Loma Linda University

Investigators


Principal Investigator:	Kristin A Seiberling, MD	Loma Linda University

More Information

No publications provided


Responsible Party:	Kristin Seiberling, MD, Associate Professor, Loma Linda University
ClinicalTrials.gov Identifier:	NCT01701960 History of Changes
Other Study ID Numbers:	5-12-0227
Study First Received:	October 3, 2012
Last Updated:	December 3, 2014
Health Authority:	United States: Institutional Review Board

ClinicalTrials.gov processed this record on February 27, 2015

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