Anesthesia; Adverse EffectNCT04275531
Neurotoxicity of Anesthesia in Middle Aged Patients
An observational study of Anesthesia; Adverse Effect, run by Tanta University at 1 site in Egypt.
Trial summary
for the last 20 years, the increasing reports from non-human studies have raised suspicion that general anesthetics may cause neurotoxic changes in the developing brain that lead to adverse neurodevelopmental outcomes later in life.there are several case reports of reversible smell and taste dysfunction following… Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Anesthesia; Adverse Effect
- What is being tested?
- Anesthesia Agent
- Type of treatment
- Injection or infusion
- How many people
- 600 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2021to 1 Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Study population: middle aged patients, of both sex, undergoing elective surgical procedures other than major surgeries, of duration 90-120 minutes, and of American Society of Anesthesiologists' physical status I and II will be enrolled in the study
Who may be able to join
- patients aged 18-50 years
- both sex
- American society of Anesthesiologists' physical status I and II
- elective surgery of duration 90-120 minutes
Who cannot join
- patients's refusal
- recent airway infection
- allergic rhinitis
- nasal polyps
- history of alcoholism
- smoking
Show all 15Show fewer
- pregnancy
- menstruating female
- mental retardation
- psychiatric illness
- neurosurgical or oto-rhino-laryngeal surgery
- history of olfactory deficits or cognitive impairment
- CNS disease e.g. epilepsy
- history of first degree relative with alzheimer's disease,dementia, or cognitive dysfunction
- those who are unable to answer the tests themselves
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Possible Neurotoxicity of Anesthesia Guided by Olfactory Changes in Middle-aged Patients
for the last 20 years, the increasing reports from non-human studies have raised suspicion that general anesthetics may cause neurotoxic changes in the developing brain that lead to adverse neurodevelopmental outcomes later in life.there are several case reports of reversible smell and taste dysfunction following exposure to general anesthesia suggesting a possible relationship between anesthetic agents and olfactory dysfunction.
this study is to assess the possible neurotoxicity of sevoflurane,isoflurane,and propofol based anesthesia guided by olfactory changes
Read the detailed description
the primary inhibitory neurotransmitter GABA is found in neuronal synapses involving olfactory bulb. So, the involvement of common GABA pathway implies a possible interaction of general anesthetics with olfactory function.
olfactory identification is an associative memory which is found to be facilitated by action of melatonin. involvement of GABA receptor in the transfer of light information from suprachiasmatic nuclei to pineal gland suggests possible interaction of melatonin and anesthetic agents.
the aim of the study is to evaluate the possible neurotoxicity of sevoflurane,isoflurane,and propofol based anesthesia guided by olfactory changes
- Conditions
- Anesthesia; Adverse Effect
- Being tested
- Anesthesia Agent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anesthesia AgentDrug
Also called Sevoflurane, Isoflurane, Propofol infusion
various anesthetic agents used in both general and regional anesthesia
| Study group | Role | What they receive |
|---|---|---|
| regional anesthesia | surgical procedures which will be performed under intrathecal anesthesia without sedation Receives: Drug: Anesthesia Agent | |
| sevoflurane | surgical procedures which will be performed under general anesthesia and sevoflurane will be used for maintenance of anesthesia Receives: Drug: Anesthesia Agent | |
| isoflurane | surgical procedures which will be performed under general anesthesia and isoflurane will be used for maintenance of anesthesia Receives: Drug: Anesthesia Agent | |
| propofol | surgical procedures which will be performed under general anesthesia and propofol infusion will be used for maintenance of anesthesia Receives: Drug: Anesthesia Agent |
What is being measured
The primary outcome is the main question the study is designed to answer.
olfactory threshold
we will use (10 dilutions) of 4% n-butyl alcohol. The odorant and a blank will be presented to the participant. The test will be progressed from weaker-to-stronger concentrations of odorant. Two bottles will be presented to each participant, an odorant bottle and an identical bottle filled with distilled water. The participant will sniff each one for 9 seconds and then will chose which one smelled stronger. If the participant is incorrect at one concentration, the next higher concentration will be presented. When the correct choice is made, the same concentration of odorant will be presented to the participant until four consecutive correct responses are given.
Measured: olfactory threshold will be measured at 12 hours preoperative then at 6, 24 and 48 hours postoperative
Secondary outcomes (3)
olfactory identification
We will use UPSIT test.
Measured: Smell identification will be measured at 12 hours preoperative then at 6, 24 and 48 hours postoperative
cognitive dysfunction
cognitive dysfunction will be evaluated by mini-mental state examination
Measured: Cognitive dysfunction will be evaluated at 12 hours preoperative then at 6, 24 and 48 hours postoperative
serum melatonin concentrations
Melatonin levels will be measured in plasma by the enzyme-linked immunosorbent assay (ELISA)
Measured: serum melatonin will be measured at 12 hours preoperative then at 6, 24 and 48 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2020
- Study start1 Mar 2021
- Primary completion1 Aug 2022 (estimated)
- Study completion1 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia; Adverse EffectStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mona Raafat Elghamry, Tanta University
- Investigators
- Mona R Elghamry, MD, Principal investigator, Tanta University, Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04275531
- Sponsor's protocol ID
- neurotoxicity of anesthesia
- Status last verified
- Mar 2022
- First submitted
- 11 Feb 2020
- Last updated
- 15 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: statistics of demographic data,type of surgeries, olfactory dysfunction tests,mini-mental state examination, and serum melatonin
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Possible Neurotoxicity of Anesthesia Guided by Olfactory Changes in Middle-aged Patients
- ClinicalTrials.gov ID
- NCT04275531
- Acronym / sponsor ID
- neurotoxicity of anesthesia
- Conditions
- Anesthesia; Adverse Effect
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 Aug 2022 (estimated)
- Study completion
- 1 Sep 2022 (estimated)
- First posted
- 19 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
for the last 20 years, the increasing reports from non-human studies have raised suspicion that general anesthetics may cause neurotoxic changes in the developing brain that lead to adverse neurodevelopmental outcomes later in life.there are several case reports of reversible smell and taste dysfunction following exposure to general anesthesia suggesting a possible relationship between anesthetic agents and olfactory dysfunction.
this study is to assess the possible neurotoxicity of sevoflurane,isoflurane,and propofol based anesthesia guided by olfactory changes
Detailed description
the primary inhibitory neurotransmitter GABA is found in neuronal synapses involving olfactory bulb. So, the involvement of common GABA pathway implies a possible interaction of general anesthetics with olfactory function.
olfactory identification is an associative memory which is found to be facilitated by action of melatonin. involvement of GABA receptor in the transfer of light information from suprachiasmatic nuclei to pineal gland suggests possible interaction of melatonin and anesthetic agents.
the aim of the study is to evaluate the possible neurotoxicity of sevoflurane,isoflurane,and propofol based anesthesia guided by olfactory changes
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| regional anesthesia | – | Drug: Anesthesia Agentsurgical procedures which will be performed under intrathecal anesthesia without sedation |
| sevoflurane | – | Drug: Anesthesia Agentsurgical procedures which will be performed under general anesthesia and sevoflurane will be used for maintenance of anesthesia |
| isoflurane | – | Drug: Anesthesia Agentsurgical procedures which will be performed under general anesthesia and isoflurane will be used for maintenance of anesthesia |
| propofol | – | Drug: Anesthesia Agentsurgical procedures which will be performed under general anesthesia and propofol infusion will be used for maintenance of anesthesia |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- middle aged patients, of both sex, undergoing elective surgical procedures other than major surgeries, of duration 90-120 minutes, and of American Society of Anesthesiologists' physical status I and II will be enrolled in the study
Key inclusion criteria (4 listed)
- patients aged 18-50 years
- both sex
- American society of Anesthesiologists' physical status I and II
- elective surgery of duration 90-120 minutes
Key exclusion criteria (15 listed)
- patients's refusal
- recent airway infection
- allergic rhinitis
- nasal polyps
- history of alcoholism
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anesthesia AgentAlso: Sevoflurane, Isoflurane, Propofol infusionvarious anesthetic agents used in both general and regional anesthesia | Drug | isoflurane, propofol, regional anesthesia, sevoflurane |
Primary outcome
olfactory threshold
Time frame: olfactory threshold will be measured at 12 hours preoperative then at 6, 24 and 48 hours postoperative
we will use (10 dilutions) of 4% n-butyl alcohol. The odorant and a blank will be presented to the participant. The test will be progressed from weaker-to-stronger concentrations of odorant. Two bottles will be presented to each participant, an odorant bottle and an identical bottle filled with distilled water. The participant will sniff each one for 9 seconds and then will chose which one smelled stronger. If the participant is incorrect at one concentration, the next higher concentration will be presented. When the correct choice is made, the same concentration of odorant will be presented to the participant until four consecutive correct responses are given.
3 secondary outcomes
olfactory identification
Time frame: Smell identification will be measured at 12 hours preoperative then at 6, 24 and 48 hours postoperative
cognitive dysfunction
Time frame: Cognitive dysfunction will be evaluated at 12 hours preoperative then at 6, 24 and 48 hours postoperative
serum melatonin concentrations
Time frame: serum melatonin will be measured at 12 hours preoperative then at 6, 24 and 48 hours postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2022.
- Individual participant dataSharing planned: Yes. statistics of demographic data,type of surgeries, olfactory dysfunction tests,mini-mental state examination, and serum melatonin
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mona R Elghamry, MD principal investigator
Tanta University, Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia; Adverse Effect, run by Tanta University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
olfactory threshold (time frame: olfactory threshold will be measured at 12 hours preoperative then at 6, 24 and 48 hours postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2022.