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Effect of Propfol Versus Sevoflurane on Auditory and Cognitive Function

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04874545
Recruitment Status : Recruiting
First Posted : May 5, 2021
Last Update Posted : May 27, 2021
Information provided by (Responsible Party):
Mona Hussein, Beni-Suef University

Brief Summary:

Perioperative hearing loss is a rarely reported phenomenon. However, it occurs more frequently than most anaesthesiologists suspect. Perioperative hearing impairment is often subclinical and may go unnoticed unless audiometry is performed.

It can be conductive or sensorineural, unilateral or bilateral, and transient or permanent. Hearing loss has been reported following virtually every type of anaesthetic technique.

The hearing mechanism may be less susceptible to acoustic trauma during general anaaesthesia. But other mechanisms are capable of causing both conductive and sensorineural hearing losses (SNHL) in the perioperative period. The aetiologies include mechanical, traumatic, noise-induced, changes in cerebrospinal fluid (CSF) pressure, embolism, pharmacologic, and other miscellaneous causes.

Stress may influence central vestibular function in health and disease either directly through the actions of glucocorticoids (cortisol and corticosterone) on ion channels and neurotransmission in the brain, or indirectly through the effects of stress-related neuroactive substances (e.g., histamine, neurosteroids) on these structures.

The auditory brainstem response (ABR) provides a good estimate of the shape of the behavioral audiogram [and is thus an extremely useful tool for studying hearing sensitivity as well as the functionality of the auditory system.

An awareness of the potential for and the causes of hearing loss during anesthesia may permit the anesthesiologist to prevent or minimize the risk of significant hearing deficit. The suggestion that this risk be discussed in the preoperative period with patients who are at high risk for perioperative hearing loss may be good medical-legal advice. Better understanding of the incidence, causes, and prognoses for perioperative hearing loss is essential for the anesthesiologist.

Much Concern has been raised about the effects of anaesthetic drugs on cognition. Postoperative cognitive dysfunction may manifest as impairment in attention, memory, language or executive functions following surgery, and can persist for weeks, months, or more with varying severity. Such post-operative cognitive dysfunction can be quite mild and only diagnosed through psychometric assessment using specific neuropsychological tests.

AIM OF THE STUDY The aim of this work is to study the possible deleterious effect of propfol versus sevoflurane on auditory and cognitive function.

Condition or disease Intervention/treatment Phase
Cognitive Dysfunction Auditory Dysfunction, Central Drug: Propofol Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Effect of Propfol Versus Sevoflurane on Auditory and Cognitive Function: A Compartive Study
Actual Study Start Date : January 1, 2021
Estimated Primary Completion Date : July 1, 2021
Estimated Study Completion Date : August 1, 2021

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Propofol group
Maintenance of anaesthesia will be done using Propofol total intravenous anesthesia (TIVA) 6-12 mg/ kg/h by syringe pump, 100 % O2.
Drug: Propofol
Total intravenous inhalational anesthesia
Other Name: Sevoflurane

Active Comparator: sevoflurane group
Maintenance of anaesthesia will be done using sevoflorane1.5-2%, 100 % O2.
Drug: Propofol
Total intravenous inhalational anesthesia
Other Name: Sevoflurane

Primary Outcome Measures :
  1. Audiometry [ Time Frame: 1 week ]
    A tool for assessment of auditory function

  2. Paired associate learning test [ Time Frame: 1 week ]
    A test for assessment of cognitive function

  3. Paced Auditory Serial Addition Test [ Time Frame: 1 week ]
    A test for assessment of cognitive function

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • ASA I-II patients who are candidate for elective extra cranial surgery.
  • Male and female patients with age between 20-60 years

Exclusion Criteria:

  • Patients with a conductive or sensorineural hearing loss
  • Patients with a history of ear infection
  • Patients with a history of ear trauma
  • Patients using ototoxic or neurotoxic drugs
  • Patients with sternocleidomastoid muscle pathology (traumatic injury or weakness) that interfere with audiological assessment
  • Patient subjected to gross hemodynamic or ventilatory fluctuations during the operation
  • Patient who developed postoperative shock or major bleeding
  • Patient with a history of neurodegenerative disease, concomitant medical or metabolic illness known to affect cognition
  • Allergy to any drug used in the study.
  • Pregnancy.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04874545

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Contact: Mona Hussein, MD 01005131318 ext +2

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Beni-Suef University Recruiting
Banī Suwayf, Egypt, 62511
Contact: Mona Hussein, MD    01005131318 ext +2   
Sponsors and Collaborators
Beni-Suef University
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Responsible Party: Mona Hussein, Associate professor of Neurology, Beni-Suef University Identifier: NCT04874545    
Other Study ID Numbers: FMBSUREC/1206018/Abdelhamid
First Posted: May 5, 2021    Key Record Dates
Last Update Posted: May 27, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hearing Disorders
Auditory Diseases, Central
Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Retrocochlear Diseases
Brain Diseases
Central Nervous System Diseases
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Platelet Aggregation Inhibitors
Anesthetics, Inhalation