Perforated Eardrum
Conditions
Keywords
tympanoplasty, Inhalational anesthesia, total intravenous anesthesia, intraoperative blood loss
Brief summary
This study aims to prospectively compare surgical field quality and intraoperative blood loss between general inhalational anesthesia to total intravenous anesthesia (TIVA) alone in subjects undergoing endoscopic ear surgery. A secondary objective is to compare rates of emergence delirium and total recovery time between the two groups.
Detailed description
In sinus surgery, TIVA has been described as a possible advantage in the use of endoscopic ear surgery. However, to date, there are no studies that examine blood loss, surgical field quality, and recovery in TIVA compared to inhalational anesthesia in the setting of endoscopic ear surgery. The hypothesis is that in patients who undergo endoscopic tympanoplasty, those who receive TIVA will have reduced intraoperative blood loss, improved surgical field quality, and reduced emergence agitation than those who receive inhalational anesthesia. This study will be a prospective double-blinded randomized control trial consisting of subjects undergoing endoscopic tympanoplasty surgery to assess intraoperative blood loss, surgical field quality, rates of emergence delirium, and recovery time.
Interventions
1.5-2%
1-2% adults 0.6-1.5% Children
1mg/kg-mcg/kg/min adults 100-200mcg/kg/min children
0.05-2ug/kg/min adults and children
Sponsors
Louisiana State University Health Sciences Center in New Orleans
Our Lady of the Lake Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Masking description
In the operating room, in order to blind the surgeon to the type of anesthesia used, a surgical drape will be placed in between the subject and the anesthesia team to conceal the anesthesia machinery and equipment. A sham intravenous pole will be at the anesthesia workstation for those subjects in the control arm to contribute to the blinding of the surgeon. Patients will not be informed about which arm they are randomly assigned to and only the anesthesiologist will be aware prior to the surgery.
Intervention model description
double-blinded randomized control
Eligibility
Sex/Gender
ALL
Age
0 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* Individuals of all ages * Scheduled to undergo an endoscopic tympanoplasty
Exclusion criteria
* Individuals with anticoagulation disorders * Those receiving anticoagulation therapy currently
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Surgical Field Quality | Post-Operative evaluation (within 2 weeks) | Neurotologists will evaluate endoscopic video clips from each surgery to assess clarity of field at different points in the surgery using the Boezaart scale grading system. It is a scale from 0-5, with 0 being the most favorable outcome and 5 being the least favorable outcome. |
| Intra-operative blood loss | 1-2 hours during surgery | Intraoperative blood loss will be determined by measuring the total number of pledgets needed to attain hemostatsis. This will be a general observation with the more pledgets needed to stop bleeding in the surgical area indicates more possible blood loss than the procedures with that require less pledgets. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Emergent Delirium and Recovery Time-Riker Scale | Immediately After extubation | Sedation and agitation will be assessed immediately after extubation using the Riker Sedation-Agitation Scale (SAS) which is on scale of 1-7 with 1 being the most favorable (easier to rouse/calm but responsive) and 7 being the least favorable (deeply sedated/higher agitation). |
| Emergent Delirium and Recovery Time-Richmond Scale | Immediately After extubation | Sedation and agitation will be assessed immediately after extubation using a second scale known as the Richmond Agitation-Sedation Scale (RASS). The RASS is on a scale of -5 to +4, with higher/more positive scores indicating worse outcomes (aka more aggressive behavior) and lower scores indicating better outcomes (less responsiveness). A score of 0(Zero) indicates a calm but alert patient. |
| Post-operative pain or complications | 0-1 hour post-operative | Patients will recover for 1 hour in the post-anesthesia care unit, and a well-trained nurse blinded to the randomized study group will evaluate pain intensity by using the numeric rating scale (0-10 range, with higher scores indicating worse pain) at three intervals: immediately after arrival, 30 minutes after arrival, and 60 minutes after arrival. Any rescue analgesics that are administered will be documented. Patients will be observed postoperatively for any adverse events, as is standard procedure. Any other adverse features such as nausea, vomiting, or changes in vision or color will be followed for 30 days post procedure. |
Countries
United States
Contacts
Primary ContactLeslie S Son, PhD
Backup ContactChristine LeBoeuf, DNP
Outcome results
None listed