Effect of Local Anesthetic on Hemodynamic Measures During Nasal Surgery

• ClinicalTrials.gov Identifier: NCT01701960
• Recruitment Status: Withdrawn
• First Posted: October 5, 2012
• Last Update Posted: March 20, 2015
• Sponsor: Loma Linda University
• Information provided by (Responsible Party): Kristin Seiberling, MD, Loma Linda University

Tracking Information

• First Submitted Date: October 3, 2012
• First Posted Date: October 5, 2012
• Last Update Posted Date: March 20, 2015
• Study Start Date: November 2012
• Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: January 24, 2013): change in blood pressure [ Time Frame: over the course of surgery ]
• Original Primary Outcome Measures: Not Provided
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Effect of Local Anesthetic on Hemodynamic Measures During Nasal Surgery
• Official Title: Effect of Local Anesthetic on Hemodynamic Measures During Nasal Surgery
• 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.

• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: Subjects ages 16-75 undergoing routine nasal surgery which will include septoplasty and sinus surgery

Condition

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

• Intervention: Not Provided

Study 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.

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Withdrawn
• Actual Enrollment (submitted: March 20, 2014): 0
• Original Estimated Enrollment (submitted: October 4, 2012): 40
• Actual Study Completion Date: August 2014
• Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 16 Years to 75 Years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01701960
• Other Study ID Numbers: 5120227
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Kristin Seiberling, MD, Loma Linda University
• Study Sponsor: Loma Linda University
• Collaborators: Not Provided

Investigators

• Principal Investigator: Kristin A Seiberling, MD; Loma Linda University

• PRS Account: Loma Linda University
• Verification Date: March 2015