Tympanum; Perforation
Conditions
Brief summary
Background: Proper selection of anesthetic technique is important in middle ear microsurgery. Controlled hypotension in ear surgery decreases blood loss with improved quality of the surgical field, however, it is associated with resistance to vasodilators and delayed recovery from anesthesia. The use of local anesthetic technique alone in middle ear surgery decreases bleeding and reduces postoperative pain, however, pain on injection, noise, and head-neck position had been reported with the increased risk of patient injuries. This study aimed to compare the effects of local ear block combined with general anesthesia versus general anesthesia alone, regarding intraoperative hemodynamics, anesthetic consumption, recovery characteristics, postoperative pain, adverse effects and postoperative complications.
Detailed description
Eighty adult patients undergoing middle ear surgery (tympanoplasty with or without mastoidectomy) were enrolled in the study. Patients were randomized into two equal groups (40 patients each). A standardized general anesthetic technique was used in both groups. Group I, received general anesthesia combined with ear block using 10 ml of 0.25% bupivacaine and (Group II), received general anesthesia alone combined with ear block using 10 ml saline. Propofol 2-3 mg /Kg was administered to induce anesthesia, which was maintained using isoflurane. Hemodynamic variables, surgical conditions including the quality of the operative field, intraoperative fentanyl, vasodilators (propranolol and nitroglycerine), isoflurane consumption, recovery time, postoperative pain, total analgesics consumption and postoperative complications were recorded
Interventions
ear block by 0.25% bupivacaine
ear block by Normal Saline Flush, 0.9% Injectable Solution
DRUGgeneral anesthetic
general anesthetic by midazolam 0.02 mg kg-1 , propofol 2-3 mg kg-1 and lidocaine 0.5 mg kg-1 , fentanyl 2 μg kg-1 , atracurium 0.5 mg kg-1 , isoflurane in 50% oxygen/air.
DRUGHypotensives
hypotensives for deliberate hypotension by nitroglycerine 0.5-10 μg /kg/min and increments of 0.2 mg propranolol
Sponsors
Abd-Elazeem Abd-Elhameed Elbakry
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
The same surgeons performed all the operations to ensure consistency in the estimation of the surgical field. To eliminate the observer bias, the observing anesthetist did not attend the induction of block. Also, the operating surgeon was blinded to the pharmacological treatments, anesthesia and performance of the used techniques.
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* ASA I or II status, * scheduled for tympanoplasty with or without mastoidectomy
Exclusion criteria
* patient refusal, * known allergy to local anesthetics * cardiovascular diseases (myocardial infarction, hypertension and valvular heart diseases) --- cerebrovascular diseases (including transient ischemic attacks), renal, hepatic insufficiency or coagulation abnormality.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| mean arterial blood pressure | at arrival to the operating room,1 minute after induction of anesthesia,1 minute after surgical incision,then every 15 minutes till the time of complete surgical wound closure. - postoperative every one hour for 4 hours then every 4 hours for 24 hours | mean arterial blood pressure in mmHg |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| quality of the operative field | every 15 minutes from start of the surgical incision till the time of complete surgical wound closure. | four-point scale from 0=no bleeding (excellent surgical conditions), 1=minimum bleeding (sporadic suction), 2= diffuse bleeding (repeated suction), and 3=abundant (troublesome) bleeding |
| recovery time | time from stopping of all anesthetics till the patient had Aldrete's score of 9. | the time from cessation of all anesthetics until complete recovery using the Aldrete's score |
| postoperative pain | postoperative: at the time that the patient had Aldrete's score of 9. ,then every 4 hours for 24 hours. | measured by visual analogue scale (from 0 no pain to10 worst imaginable pain) |
| total analgesic consumption | in the first 24 hours postoperative | ketorolac consumption in mg |
| nitroglycerine consumption | during the operation time | total nitroglycerine consumption in ug |
| heart rate | at arrival to the operating room,1 minute after induction of anesthesia,1 minute after surgical incision,then every 15 minutes till the time of complete surgical wound closure. - postoperative every one hour for 4 hours then every 4 hours for 24 hours | heart rate in beats /minute |
| nausea | in the first 24 hours postoperative | the number of patients who developed nausea |
| vomiting | in the first 24 hours postoperative | the number of patients who developed vomiting |
| headache | in the first 24 hours postoperative | the number of patients who developed headache |
| facial palsy | in the first 24 hours postoperative | the number of patients who developed facial palsy |
| propranolol consumption | during the operation time | total propranolol consumption in mg |
Countries
Egypt
Outcome results
None listed