Effect of Local Anesthetic on Hemodynamic Measures During Nasal Surgery

NCT01701960 | Withdrawn DMC

• 1 other identifier: 5120227
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• change in blood pressure

  over the course of surgery

Study Arms (2)

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.

Eligibility Criteria

• Age: 16 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• allergy to lidocaine,
• recent MI,
• recent stroke,
• uncontrolled hypertension,
• arrhythmias,
• congestive heart failure.

Sponsors & Collaborators

• Loma Linda University: lead

Study Sites (1)

Loma Linda University Medical Center

Loma Linda, California, 92354, United States

Location

Study Officials

• Kristin A Seiberling, MD

  Loma Linda University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 3, 2012
• First Posted: October 5, 2012
• Study Start: November 1, 2012
• Primary Completion: February 1, 2014
• Study Completion: August 1, 2014
• Last Updated: March 20, 2015

Record last verified: 2015-03

Locations

US (1)