Effect of Local Anesthetic on Hemodynamic Measures During Nasal Surgery
Blood Loss During Surgery
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Effect of Local Anesthetic on Hemodynamic Measures During Nasal Surgery|
- change in blood pressure [ Time Frame: over the course of surgery ] [ Designated as safety issue: No ]
|Study Start Date:||November 2012|
|Study Completion Date:||August 2014|
|Estimated Primary Completion Date:||February 2014 (Final data collection date for primary outcome measure)|
This cohort will be injected with 1% lidocaine with 1:100,000 of epinephrine into the nasal mucosa at the time of nasal surgery
This group will be injected with 1% lidocaine with 1:200,000 of epinephrine into the nasal mucosa at the start of nasal surgery.
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).
- 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.
- Heart rate
- Blood pressure
- Routine ECG monitoring
- MAP (mean arterial pressure)
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01701960
|United States, California|
|Loma Linda University Medical Center|
|Loma Linda, California, United States, 92354|
|Principal Investigator:||Kristin A Seiberling, MD||Loma Linda University|