Effect of Local Anesthetic on Hemodynamic Measures During Nasal Surgery

NCT ID: NCT01701960

Last Updated: 2015-03-20

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-11-30
• Study Completion Date: 2014-08-31

Brief Summary

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.

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

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.

Conditions

Heart Rate; Blood Pressure; Blood Loss During Surgery; Surgical Field

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility 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.

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Loma Linda University

OTHER

Sponsor Role: lead

Responsible Party

Kristin Seiberling, MD

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kristin A Seiberling, MD

Role: PRINCIPAL_INVESTIGATOR

Loma Linda University

Locations

Loma Linda University Medical Center

Loma Linda, California, United States

Countries

United States

Other Identifiers

5120227

Identifier Type: -

Identifier Source: org_study_id