Tympanum; Perforation Clinical Trial
Official title:
General Anesthesia With or Without Local Ear Block in Middle Ear Surgeries; A Randomised, Double-blind Trial
Verified date | April 2019 |
Source | Menoufia University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 80 |
Est. completion date | December 30, 2018 |
Est. primary completion date | December 1, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Egypt | Faculty of Medicine | Cairo | Shebin El-kom |
Lead Sponsor | Collaborator |
---|---|
Abd-Elazeem Abd-Elhameed Elbakry |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | mean arterial blood pressure | mean arterial blood pressure in mmHg | 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 | |
Secondary | heart rate | heart rate in beats /minute | 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 | |
Secondary | quality of the operative field | 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 | every 15 minutes from start of the surgical incision till the time of complete surgical wound closure. | |
Secondary | recovery time | the time from cessation of all anesthetics until complete recovery using the Aldrete's score | time from stopping of all anesthetics till the patient had Aldrete's score of 9. | |
Secondary | postoperative pain | measured by visual analogue scale (from 0 "no pain" to10 "worst imaginable pain") | postoperative: at the time that the patient had Aldrete's score of 9. ,then every 4 hours for 24 hours. | |
Secondary | total analgesic consumption | ketorolac consumption in mg | in the first 24 hours postoperative | |
Secondary | nitroglycerine consumption | total nitroglycerine consumption in ug | during the operation time | |
Secondary | propranolol consumption | total propranolol consumption in mg | during the operation time | |
Secondary | nausea | the number of patients who developed nausea | in the first 24 hours postoperative | |
Secondary | vomiting | the number of patients who developed vomiting | in the first 24 hours postoperative | |
Secondary | headache | the number of patients who developed headache | in the first 24 hours postoperative | |
Secondary | facial palsy | the number of patients who developed facial palsy | in the first 24 hours postoperative |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
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