Effect of Propfol Versus Sevoflurane on Auditory and Cognitive Function

NCT04874545 | Completed Phase 4

• 1 other identifier: FMBSUREC/1206018/Abdelhamid
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Cognitive Dysfunction; Auditory Dysfunction, Central

Outcome Measures

Primary Outcomes (3)

• Audiometry

  A tool for assessment of auditory function

  1 week

• Paired associate learning test

  A test for assessment of cognitive function

  1 week

• Paced Auditory Serial Addition Test

  A test for assessment of cognitive function

  1 week

Study Arms (2)

Propofol group

EXPERIMENTAL

Maintenance of anaesthesia will be done using Propofol total intravenous anesthesia (TIVA) 6-12 mg/ kg/h by syringe pump, 100 % O2.

Drug: Propofol

sevoflurane group

ACTIVE COMPARATOR

Maintenance of anaesthesia will be done using sevoflorane1.5-2%, 100 % O2.

Drug: Propofol

Interventions

Propofol DRUG

Total intravenous inhalational anesthesia

Also known as: Sevoflurane

Propofol group; sevoflurane group

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beni-Suef University: lead

Study Sites (1)

Beni-Suef University

Banī Suwayf, 62511, Egypt

Location

MeSH Terms

Conditions

Cognitive Dysfunction; Auditory Diseases, Central

Interventions

Propofol; Sevoflurane

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Retrocochlear Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Methyl Ethers; Ethers; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor of Neurology

Study Record Dates

• First Submitted: April 17, 2021
• First Posted: May 5, 2021
• Study Start: June 1, 2021
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: May 6, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)