General Anesthesia With or Without Local Ear Block in Middle Ear Surgeries; A Randomised, Double-blind Trial
Overview
- Phase
- Not Applicable
- Intervention
- local anaesthetic injection
- Conditions
- Tympanum; Perforation
- Sponsor
- Abd-Elazeem Abd-Elhameed Elbakry
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- mean arterial blood pressure
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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
Investigators
Abd-Elazeem Abd-Elhameed Elbakry
assistant professor of anesthesia
Menoufia University
Eligibility Criteria
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.
Arms & Interventions
group l
ear block by local anaesthetic injection 0.25% bupivacaine. 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. hypotensives for deliberate hypotension by nitroglycerine 0.5-10 μg /kg/min and increments of 0.2 mg propranolol
Intervention: local anaesthetic injection
group l
ear block by local anaesthetic injection 0.25% bupivacaine. 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. hypotensives for deliberate hypotension by nitroglycerine 0.5-10 μg /kg/min and increments of 0.2 mg propranolol
Intervention: general anesthetic
group l
ear block by local anaesthetic injection 0.25% bupivacaine. 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. hypotensives for deliberate hypotension by nitroglycerine 0.5-10 μg /kg/min and increments of 0.2 mg propranolol
Intervention: Hypotensives
Group II
ear block by Normal Saline Flush, 0.9% Injectable Solution . 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. hypotensives for deliberate hypotension by nitroglycerine 0.5-10 μg /kg/min and increments of 0.2 mg propranolol
Intervention: Normal Saline Flush, 0.9% Injectable Solution
Group II
ear block by Normal Saline Flush, 0.9% Injectable Solution . 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. hypotensives for deliberate hypotension by nitroglycerine 0.5-10 μg /kg/min and increments of 0.2 mg propranolol
Intervention: general anesthetic
Group II
ear block by Normal Saline Flush, 0.9% Injectable Solution . 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. hypotensives for deliberate hypotension by nitroglycerine 0.5-10 μg /kg/min and increments of 0.2 mg propranolol
Intervention: Hypotensives
Outcomes
Primary Outcomes
mean arterial blood pressure
Time Frame: 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 Outcomes
- headache(in the first 24 hours postoperative)
- nitroglycerine consumption(during the operation time)
- propranolol consumption(during the operation time)
- vomiting(in the first 24 hours postoperative)
- 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)
- recovery time(time from stopping of all anesthetics till the patient had Aldrete's score of 9.)
- postoperative pain(postoperative: at the time that the patient had Aldrete's score of 9. ,then every 4 hours for 24 hours.)
- total analgesic consumption(in the first 24 hours postoperative)
- nausea(in the first 24 hours postoperative)
- facial palsy(in the first 24 hours postoperative)
- quality of the operative field(every 15 minutes from start of the surgical incision till the time of complete surgical wound closure.)