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

NCT03569046 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2019-04-25

No results posted yet for this study

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.

Conditions

  • Tympanum; Perforation

Interventions

DRUG

local anaesthetic injection

ear block by 0.25% bupivacaine

DRUG

Normal Saline Flush, 0.9% Injectable Solution

ear block by Normal Saline Flush, 0.9% Injectable Solution

DRUG

general 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.

DRUG

Hypotensives

hypotensives for deliberate hypotension by nitroglycerine 0.5-10 μg /kg/min and increments of 0.2 mg propranolol

Sponsors & Collaborators

  • Abd-Elazeem Abd-Elhameed Elbakry

    lead OTHER

Principal Investigators

  • Abd-Elazeem A Elbakry, M.D · Assistant professor

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-06
Primary Completion
2018-12-01
Completion
2018-12-30

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03569046 on ClinicalTrials.gov