Tympanum; PerforationNCT03569046
General Anesthesia With or Without Local Ear Block in Middle Ear Surgeries
A study testing local anaesthetic injection, Normal Saline Flush, 0.9% Injectable Solution and general anesthetic in people with Tympanum; Perforation, run by Abd-Elazeem Abd-Elhameed Elbakry at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Tympanum; Perforation
- What is being tested?
- local anaesthetic injection, Normal Saline Flush, 0.9% Injectable Solution and general anesthetic
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 6 Jul 2018to 30 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- ASA I or II status,
- scheduled for tympanoplasty with or without mastoidectomy
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: General Anesthesia With or Without Local Ear Block in Middle Ear Surgeries; A Randomised, Double-blind Trial
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.
Read the 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
- Conditions
- Tympanum; Perforation
- Being tested
- local anaesthetic injection, Normal Saline Flush, 0.9% Injectable Solution, general anesthetic, Hypotensives
- Medical subject headings
- Tympanic Membrane Perforation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
local anaesthetic injectionDrug
Also called 0.25% bupivacaine
ear block by 0.25% bupivacaine
Normal Saline Flush, 0.9% Injectable SolutionDrug
Also called saline ear block
ear block by Normal Saline Flush, 0.9% Injectable Solution
general anestheticDrug
Also called general anesthesia
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.
HypotensivesDrug
Also called deliberate hypotension
hypotensives for deliberate hypotension by nitroglycerine 0.5-10 μg /kg/min and increments of 0.2 mg propranolol
| Study group | Role | What they receive |
|---|---|---|
| group l | Active comparator | 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 Receives: Drug: local anaesthetic injection; Drug: general anesthetic; Drug: Hypotensives |
| Group II | Placebo comparator | 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 Receives: Drug: Normal Saline Flush, 0.9% Injectable Solution; Drug: general anesthetic; Drug: Hypotensives |
What is being measured
The primary outcome is the main question the study is designed to answer.
mean arterial blood pressure
mean arterial blood pressure in mmHg
Measured: 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 outcomes (11)
heart rate
heart rate in beats /minute
Measured: 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
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
Measured: every 15 minutes from start of the surgical incision till the time of complete surgical wound closure.
recovery time
the time from cessation of all anesthetics until complete recovery using the Aldrete's score
Measured: time from stopping of all anesthetics till the patient had Aldrete's score of 9.
postoperative pain
measured by visual analogue scale (from 0 "no pain" to10 "worst imaginable pain")
Measured: postoperative: at the time that the patient had Aldrete's score of 9. ,then every 4 hours for 24 hours.
total analgesic consumption
ketorolac consumption in mg
Measured: in the first 24 hours postoperative
nitroglycerine consumption
total nitroglycerine consumption in ug
Measured: during the operation time
propranolol consumption
total propranolol consumption in mg
Measured: during the operation time
nausea
the number of patients who developed nausea
Measured: in the first 24 hours postoperative
vomiting
the number of patients who developed vomiting
Measured: in the first 24 hours postoperative
headache
the number of patients who developed headache
Measured: in the first 24 hours postoperative
facial palsy
the number of patients who developed facial palsy
Measured: in the first 24 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2018
- Study start6 Jul 2018
- Primary completion1 Dec 2018
- Study completion30 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tympanum; PerforationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abd-Elazeem Abd-Elhameed Elbakry
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Abd-Elazeem Abd-Elhameed Elbakry, Menoufia University
- Investigators
- Abd-Elazeem A Elbakry, M.D, Study director, Assistant professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03569046
- Sponsor's protocol ID
- 2017/12/8/8
- Status last verified
- Apr 2019
- First submitted
- 18 May 2018
- Last updated
- 25 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- General Anesthesia With or Without Local Ear Block in Middle Ear Surgeries; A Randomised, Double-blind Trial
- ClinicalTrials.gov ID
- NCT03569046
- Acronym / sponsor ID
- 2017/12/8/8
- Conditions
- Tympanum; Perforation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Abd-Elazeem Abd-Elhameed ElbakryUniversity, hospital or other
- Study start
- 6 Jul 2018 (actual)
- Primary completion
- 1 Dec 2018 (actual)
- Study completion
- 30 Dec 2018 (actual)
- First posted
- 26 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group l | Active comparator | Drug: local anaesthetic injection, Drug: general anesthetic, Drug: Hypotensivesear 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 |
| Group II | Placebo comparator | Drug: Normal Saline Flush, 0.9% Injectable Solution, Drug: general anesthetic, Drug: Hypotensivesear 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 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- ASA I or II status,
- scheduled for tympanoplasty with or without mastoidectomy
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| local anaesthetic injectionAlso: 0.25% bupivacaineear block by 0.25% bupivacaine | Drug | group l |
| Normal Saline Flush, 0.9% Injectable SolutionAlso: saline ear blockear block by Normal Saline Flush, 0.9% Injectable Solution | Drug | Group II |
| general anestheticAlso: general anesthesiageneral 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. | Drug | Group II, group l |
| HypotensivesAlso: deliberate hypotensionhypotensives for deliberate hypotension by nitroglycerine 0.5-10 μg /kg/min and increments of 0.2 mg propranolol | Drug | Group II, group l |
Primary outcome
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
11 secondary outcomes
heart rate
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
quality of the operative field
Time frame: every 15 minutes from start of the surgical incision till the time of complete surgical wound closure.
recovery time
Time frame: time from stopping of all anesthetics till the patient had Aldrete's score of 9.
postoperative pain
Time frame: postoperative: at the time that the patient had Aldrete's score of 9. ,then every 4 hours for 24 hours.
total analgesic consumption
Time frame: in the first 24 hours postoperative
nitroglycerine consumption
Time frame: during the operation time
propranolol consumption
Time frame: during the operation time
nausea
Time frame: in the first 24 hours postoperative
vomiting
Time frame: in the first 24 hours postoperative
headache
Time frame: in the first 24 hours postoperative
facial palsy
Time frame: in the first 24 hours postoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abd-Elazeem A Elbakry, M.D study director
Assistant professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing local anaesthetic injection, Normal Saline Flush, 0.9% Injectable Solution and general anesthetic in people with Tympanum; Perforation, run by Abd-Elazeem Abd-Elhameed Elbakry at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2019.