Effect of Local Anesthetic on Hemodynamic Measures During Nasal Surgery
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ClinicalTrials.gov Identifier: NCT01701960 |
Recruitment Status :
Withdrawn
(no time)
First Posted : October 5, 2012
Last Update Posted : March 20, 2015
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Condition or disease |
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Heart Rate Blood Pressure Blood Loss During Surgery Surgical Field |
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
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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.
Study Type : | Observational |
Actual Enrollment : | 0 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Effect of Local Anesthetic on Hemodynamic Measures During Nasal Surgery |
Study Start Date : | November 2012 |
Estimated Primary Completion Date : | February 2014 |
Actual Study Completion Date : | August 2014 |
Group/Cohort |
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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
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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.
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- change in blood pressure [ Time Frame: over the course of surgery ]

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, Learn About Clinical Studies.
Ages Eligible for Study: | 16 Years to 75 Years (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01701960
United States, California | |
Loma Linda University Medical Center | |
Loma Linda, California, United States, 92354 |
Principal Investigator: | Kristin A Seiberling, MD | Loma Linda University |
Responsible Party: | Kristin Seiberling, MD, Associate Professor, Loma Linda University |
ClinicalTrials.gov Identifier: | NCT01701960 |
Other Study ID Numbers: |
5120227 |
First Posted: | October 5, 2012 Key Record Dates |
Last Update Posted: | March 20, 2015 |
Last Verified: | March 2015 |
Hemorrhage Pathologic Processes |