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General Anesthesia With or Without Local Ear Block in Middle Ear Surgeries

Primary Purpose

Tympanum; Perforation

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
local anaesthetic injection
Normal Saline Flush, 0.9% Injectable Solution
general anesthetic
Hypotensives
Sponsored by
Abd-Elazeem Abd-Elhameed Elbakry
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Tympanum; Perforation

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Faculty of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

group l

Group II

Arm Description

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

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

Outcomes

Primary Outcome Measures

mean arterial blood pressure
mean arterial blood pressure in mmHg

Secondary Outcome Measures

heart rate
heart rate in beats /minute
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
recovery time
the time from cessation of all anesthetics until complete recovery using the Aldrete's score
postoperative pain
measured by visual analogue scale (from 0 "no pain" to10 "worst imaginable pain")
total analgesic consumption
ketorolac consumption in mg
nitroglycerine consumption
total nitroglycerine consumption in ug
propranolol consumption
total propranolol consumption in mg
nausea
the number of patients who developed nausea
vomiting
the number of patients who developed vomiting
headache
the number of patients who developed headache
facial palsy
the number of patients who developed facial palsy

Full Information

First Posted
May 18, 2018
Last Updated
April 24, 2019
Sponsor
Abd-Elazeem Abd-Elhameed Elbakry
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1. Study Identification

Unique Protocol Identification Number
NCT03569046
Brief Title
General Anesthesia With or Without Local Ear Block in Middle Ear Surgeries
Official Title
General Anesthesia With or Without Local Ear Block in Middle Ear Surgeries; A Randomised, Double-blind Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
July 6, 2018 (Actual)
Primary Completion Date
December 1, 2018 (Actual)
Study Completion Date
December 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Abd-Elazeem Abd-Elhameed Elbakry

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tympanum; Perforation

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
group l
Arm Type
Active Comparator
Arm Description
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
Arm Title
Group II
Arm Type
Placebo Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
local anaesthetic injection
Other Intervention Name(s)
0.25% bupivacaine
Intervention Description
ear block by 0.25% bupivacaine
Intervention Type
Drug
Intervention Name(s)
Normal Saline Flush, 0.9% Injectable Solution
Other Intervention Name(s)
saline ear block
Intervention Description
ear block by Normal Saline Flush, 0.9% Injectable Solution
Intervention Type
Drug
Intervention Name(s)
general anesthetic
Other Intervention Name(s)
general anesthesia
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Hypotensives
Other Intervention Name(s)
deliberate hypotension
Intervention Description
hypotensives for deliberate hypotension by nitroglycerine 0.5-10 μg /kg/min and increments of 0.2 mg propranolol
Primary Outcome Measure Information:
Title
mean arterial blood pressure
Description
mean arterial blood pressure in mmHg
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
Secondary Outcome Measure Information:
Title
heart rate
Description
heart rate in beats /minute
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
Title
quality of the operative field
Description
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
Time Frame
every 15 minutes from start of the surgical incision till the time of complete surgical wound closure.
Title
recovery time
Description
the time from cessation of all anesthetics until complete recovery using the Aldrete's score
Time Frame
time from stopping of all anesthetics till the patient had Aldrete's score of 9.
Title
postoperative pain
Description
measured by visual analogue scale (from 0 "no pain" to10 "worst imaginable pain")
Time Frame
postoperative: at the time that the patient had Aldrete's score of 9. ,then every 4 hours for 24 hours.
Title
total analgesic consumption
Description
ketorolac consumption in mg
Time Frame
in the first 24 hours postoperative
Title
nitroglycerine consumption
Description
total nitroglycerine consumption in ug
Time Frame
during the operation time
Title
propranolol consumption
Description
total propranolol consumption in mg
Time Frame
during the operation time
Title
nausea
Description
the number of patients who developed nausea
Time Frame
in the first 24 hours postoperative
Title
vomiting
Description
the number of patients who developed vomiting
Time Frame
in the first 24 hours postoperative
Title
headache
Description
the number of patients who developed headache
Time Frame
in the first 24 hours postoperative
Title
facial palsy
Description
the number of patients who developed facial palsy
Time Frame
in the first 24 hours postoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abd-Elazeem A Elbakry, M.D
Organizational Affiliation
Assistant professor
Official's Role
Study Director
Facility Information:
Facility Name
Faculty of Medicine
City
Cairo
State/Province
Shebin El-kom
ZIP/Postal Code
32511
Country
Egypt

12. IPD Sharing Statement

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General Anesthesia With or Without Local Ear Block in Middle Ear Surgeries

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