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

NCT03569046 | Completed

• 1 other identifier: 2017/12/8/8
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Tympanum; Perforation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• 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

• quality of the operative field

  every 15 minutes from start of the surgical incision till the time of complete surgical wound closure.

• 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

Study Arms (2)

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

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

Drug: Normal Saline Flush, 0.9% Injectable Solution; Drug: general anesthetic; Drug: Hypotensives

Interventions

local anaesthetic injection DRUG

ear block by 0.25% bupivacaine

Also known as: 0.25% bupivacaine

group l

Normal Saline Flush, 0.9% Injectable Solution DRUG

ear block by Normal Saline Flush, 0.9% Injectable Solution

Also known as: saline ear block

Group II

general anesthetic DRUG

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.

Also known as: general anesthesia

Group II; group l

Hypotensives DRUG

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

Also known as: deliberate hypotension

Group II; group l

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• ASA I or II status,
• scheduled for tympanoplasty with or without mastoidectomy

You may not qualify if:

• 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.

Sponsors & Collaborators

• Abd-Elazeem Abd-Elhameed Elbakry: lead

Study Sites (1)

Faculty of Medicine

Cairo, Shebin El-kom, 32511, Egypt

Location

MeSH Terms

Conditions

Tympanic Membrane Perforation

Interventions

Anesthesia, Local; Bupivacaine; Anesthetics, General; Anesthesia, General; Antihypertensive Agents

Condition Hierarchy (Ancestors)

Ear Diseases; Otorhinolaryngologic Diseases; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Central Nervous System Agents; Therapeutic Uses; Cardiovascular Agents

Study Officials

• Abd-Elazeem A Elbakry, M.D

  Assistant professor

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: assistant professor of anesthesia

Study Record Dates

• First Submitted: May 18, 2018
• First Posted: June 26, 2018
• Study Start: July 6, 2018
• Primary Completion: December 1, 2018
• Study Completion: December 30, 2018
• Last Updated: April 25, 2019

Record last verified: 2019-04

Locations

EG (1)