Ignite Creation Date:
2024-05-06 @ 4:07 PM
Last Modification Date:
2024-10-26 @ 2:04 PM
Study NCT ID:
NCT04874545
Status:
COMPLETED
Last Update Posted:
2022-05-06
First Post:
2021-04-17
Brief Title:
Effect of Propfol Versus Sevoflurane on Auditory and Cognitive Function
Sponsor:
Beni-Suef University
Organization:
Beni-Suef University
Study Overview
Official Title:
Effect of Propfol Versus Sevoflurane on Auditory and Cognitive Function A Compartive Study
Status:
COMPLETED
Status Verified Date:
2022-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 eg 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
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 eg 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
Detailed Description:
Type and site of the study
This study will be carried out at Beni-Suef university hospital after approval by the department of Anaesthesiology the local ethics and research committee and other involved departments faculty of medicine Beni-Suef University
Date of the study
The study will be performed starting from 1st of January 2021
Study design and population This is a prospective randomized study that will be carried out on patients subjected to general anaesthesia
Sampling Technique
Patients will be randomly assigned into one of two equal groups Randomization will be carried out using a closed opaque envelope technique with the anesthetist will pick up a sealed envelope which contains a paper with the name of the group to which the patient will be randomized is written Whichever the group written on the paper the patient will be scheduled to it
The patients will be subjected to the following
A routine preoperative check-up will be performed Routine hematological and biochemical testing along with electrocardiograms will be performed for patients The procedure will be explained to the patients
On arrival to the operating theatre 18 G intravenous cannula will be inserted and IV crystalloid fluids will be infused the monitor will be attached to the patients to take preoperative readings of heart rate non-invasive arterial blood pressure SpO2
The patients will be randomly divided to one of two groups
Group 1
Induction of anesthesia will be done by injecting fentanyl 2 μgkg propofol15-25 mgkg and atracurium 05 mgkg for muscle relaxation Laryngoscopy and endotracheal intubation will be performed using oral cuffed tube lubricated with lidocaine jelly 2
Maintenance of anaesthesia will be done using Propofol total intravenous anesthesia TIVA 6-12 mg kgh by syringe pump 100 O2
Group 2
Induction of anesthesia will be done by injecting fentanyl 2 μgkg propofol15-25 mgkg and atracurium 05 mgkg for muscle relaxation Laryngoscopy and endotracheal intubation will be performed using oral cuffed tube lubricated with lidocaine jelly 2
Maintenance of anaesthesia will be done using sevoflorane15-2 100 O2 The concentrations of propofol and sevoflorane will be adjusted according to patients vital sign
Ventilation in both groups will be controlled artificially to maintain an end-tidal partial pressure of carbon dioxide of 33-35 mmHg
At the end of surgery neuromuscular blockade will be reversed with IV neostigmine 004mgkg and atropine 002 mgkg the trachea will be extubated when the patient respond to commands all patients will be transferred to PACU where they receive oxygen via face mask 3-4 Lmin and will be monitored
The following parameters will be evaluated and recorded by senior anesthesiologist unaware of the study protocol
1 Demographic data age and sex
2 Operation type
3 Duration of anesthesia
4 Hemodynamics of the patients Mean arterial blood pressure and heart rate SPO2 End tidal CO2 will be continuously monitored and recorded every 15 minutes
All included patients will be subjected to the following preoperative and 1 week postoperative
1 Cognitive assessment
Cognitive functions for the patients will be assessed using the following psychometric tests
1 Paired Associate Learning test PALT 9
Aim to assess auditory verbal memory The test uses the concept of semantic cueing
Administration and scoring In this test the examiner says ten associated pairs in front of the candidate These pairs contain 6 compatible semantically related pairs and 4 incompatible semantically unrelated pairs After one minute the candidate is given the first word of the pairs and is asked to recall the second word The test is repeated three times Each correct compatible pair takes a score 05 while each correct incompatible pair takes a score 1 The total score ranges from 0 to 21
2 Paced Auditory Serial Addition Test PASAT 10
Aim Paced Auditory Serial Addition test is used for assessment of attention and auditory working memory
Administration and scoring In this test a series of 61 single digit numbers are spoken on an audiotape or CD at a rate of one every 3 seconds The subject is asked to add each number to the one immediately preceding it and not to give a running total The subject has to report the sum orally Total score is the sum of correct responses and it ranges from 0 to 60
2 Audiological assessment
1 Audiological evaluation tonal audiometry in the frequency range 025 - 8 kHz Using orbiter 922 in a sound treated room with a TDH 39 earphones Speech audiometry including speech reception threshold SRT using arabic spondee words 11 and word discrimination score WDS using arabic phonetically balanced PB words 11 Immittancemetry will be done using AD 629 Interacoustic calibrated according to the ISO standard using single-component single-frequency tympanometry with a probe tone of 226 Hz Testing of the acoustic reflex threshold for ipsilateral and contralateral elicited reflexes using pure tones at 500 1000 2000 and 4000 Hz
2 Brainstem auditory evoked potentials BAEPs will be performed using Interacoustic Eclipse EP25 The reference electrodes will be placed on the rightA2 and left Al mastoids the active is on the scalp at the vertex Fz position of the 10-20 International System of EEG electrode placement and the ground electrode is on the lower mid-frontal area Fpz position AgAgCl electrodes filled with conductive paste will be fixed to skin that will be abraded with a skin prepping gel Electrode impedances will be less than 5 kΩ and inter-electrode impedances will be less than 2 kΩ The subject should be in relaxed state Click is presented through TDH39 headphones Click will be presented at a rate of 211 stimuli per second in rarefaction polarity at intensity of 80 dBHL Averaged potentials to 1200 clicks will be obtained Two recordings will be obtained to ensure the replicability of the waveforms The latencies of waves I III V and interpeak latencies I-V I- III III-V IPLs will be studied with BAEPs
This study will be carried out at Beni-Suef university hospital after approval by the department of Anaesthesiology the local ethics and research committee and other involved departments faculty of medicine Beni-Suef University
Date of the study
The study will be performed starting from 1st of January 2021
Study design and population This is a prospective randomized study that will be carried out on patients subjected to general anaesthesia
Sampling Technique
Patients will be randomly assigned into one of two equal groups Randomization will be carried out using a closed opaque envelope technique with the anesthetist will pick up a sealed envelope which contains a paper with the name of the group to which the patient will be randomized is written Whichever the group written on the paper the patient will be scheduled to it
The patients will be subjected to the following
A routine preoperative check-up will be performed Routine hematological and biochemical testing along with electrocardiograms will be performed for patients The procedure will be explained to the patients
On arrival to the operating theatre 18 G intravenous cannula will be inserted and IV crystalloid fluids will be infused the monitor will be attached to the patients to take preoperative readings of heart rate non-invasive arterial blood pressure SpO2
The patients will be randomly divided to one of two groups
Group 1
Induction of anesthesia will be done by injecting fentanyl 2 μgkg propofol15-25 mgkg and atracurium 05 mgkg for muscle relaxation Laryngoscopy and endotracheal intubation will be performed using oral cuffed tube lubricated with lidocaine jelly 2
Maintenance of anaesthesia will be done using Propofol total intravenous anesthesia TIVA 6-12 mg kgh by syringe pump 100 O2
Group 2
Induction of anesthesia will be done by injecting fentanyl 2 μgkg propofol15-25 mgkg and atracurium 05 mgkg for muscle relaxation Laryngoscopy and endotracheal intubation will be performed using oral cuffed tube lubricated with lidocaine jelly 2
Maintenance of anaesthesia will be done using sevoflorane15-2 100 O2 The concentrations of propofol and sevoflorane will be adjusted according to patients vital sign
Ventilation in both groups will be controlled artificially to maintain an end-tidal partial pressure of carbon dioxide of 33-35 mmHg
At the end of surgery neuromuscular blockade will be reversed with IV neostigmine 004mgkg and atropine 002 mgkg the trachea will be extubated when the patient respond to commands all patients will be transferred to PACU where they receive oxygen via face mask 3-4 Lmin and will be monitored
The following parameters will be evaluated and recorded by senior anesthesiologist unaware of the study protocol
1 Demographic data age and sex
2 Operation type
3 Duration of anesthesia
4 Hemodynamics of the patients Mean arterial blood pressure and heart rate SPO2 End tidal CO2 will be continuously monitored and recorded every 15 minutes
All included patients will be subjected to the following preoperative and 1 week postoperative
1 Cognitive assessment
Cognitive functions for the patients will be assessed using the following psychometric tests
1 Paired Associate Learning test PALT 9
Aim to assess auditory verbal memory The test uses the concept of semantic cueing
Administration and scoring In this test the examiner says ten associated pairs in front of the candidate These pairs contain 6 compatible semantically related pairs and 4 incompatible semantically unrelated pairs After one minute the candidate is given the first word of the pairs and is asked to recall the second word The test is repeated three times Each correct compatible pair takes a score 05 while each correct incompatible pair takes a score 1 The total score ranges from 0 to 21
2 Paced Auditory Serial Addition Test PASAT 10
Aim Paced Auditory Serial Addition test is used for assessment of attention and auditory working memory
Administration and scoring In this test a series of 61 single digit numbers are spoken on an audiotape or CD at a rate of one every 3 seconds The subject is asked to add each number to the one immediately preceding it and not to give a running total The subject has to report the sum orally Total score is the sum of correct responses and it ranges from 0 to 60
2 Audiological assessment
1 Audiological evaluation tonal audiometry in the frequency range 025 - 8 kHz Using orbiter 922 in a sound treated room with a TDH 39 earphones Speech audiometry including speech reception threshold SRT using arabic spondee words 11 and word discrimination score WDS using arabic phonetically balanced PB words 11 Immittancemetry will be done using AD 629 Interacoustic calibrated according to the ISO standard using single-component single-frequency tympanometry with a probe tone of 226 Hz Testing of the acoustic reflex threshold for ipsilateral and contralateral elicited reflexes using pure tones at 500 1000 2000 and 4000 Hz
2 Brainstem auditory evoked potentials BAEPs will be performed using Interacoustic Eclipse EP25 The reference electrodes will be placed on the rightA2 and left Al mastoids the active is on the scalp at the vertex Fz position of the 10-20 International System of EEG electrode placement and the ground electrode is on the lower mid-frontal area Fpz position AgAgCl electrodes filled with conductive paste will be fixed to skin that will be abraded with a skin prepping gel Electrode impedances will be less than 5 kΩ and inter-electrode impedances will be less than 2 kΩ The subject should be in relaxed state Click is presented through TDH39 headphones Click will be presented at a rate of 211 stimuli per second in rarefaction polarity at intensity of 80 dBHL Averaged potentials to 1200 clicks will be obtained Two recordings will be obtained to ensure the replicability of the waveforms The latencies of waves I III V and interpeak latencies I-V I- III III-V IPLs will be studied with BAEPs
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None