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Evaluation of Neurotoxic Effect of Sevoflurane‑Based AnaesthesiaGuided by Short‑Term Olfactory Identification

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ClinicalTrials.gov Identifier: NCT03726580
Recruitment Status : Completed
First Posted : October 31, 2018
Last Update Posted : October 31, 2018
Sponsor:
Collaborator:
Amer Galal Younis,MD
Information provided by (Responsible Party):
Ahmed Said Elgebaly,MD, Tanta University

Brief Summary:
Nowadays there is increasing doubts about the safety of anesthesia . Anesthesiologists have to console the worried patients, who are anxious about the potential risks of anesthetic-induced brain damage, by suggesting that any detrimental effects would be "mild".Anesthetics are responsible for postoperative taste and odor defects and cognitive dysfunction.

Condition or disease Intervention/treatment
Neurotoxic Effect of Sevoflurane‑Based Anaesthesia Drug: Sevoflurane

Detailed Description:

Aims: The aim of this study is to assess the effect of isoflurane, sevoflurane, propofol and regional anesthesia on the olfactory threshold, olfactory identification and endocrine regulation of associative memory in the postoperative period in old age group.

Methods: 600 patients (> 60years ) fulfilling the criteria of the American society of anesthesiologists and II status were selected for this prospective single-blinded randomized controlled study. Patients were randomized into one of four groups to receive regional anesthesia (control group), general anesthesia with sevoflurane, general anesthesia with isoflurane and total intravenous anesthesia with propofol.

Mini-Mental State Examination (MMSE), olfactory threshold, and olfactory identification were tested at 12 hours preoperatively (T0), at 3 hours postoperatively (T1) and at the time of discharge or postoperative 3 days (T2). In addition, serum melatonin levels were estimated at T0 and T1.

N‑butyl alcohol was used to test the olfactory threshold and the Pocket Smell Test TM series (PSTs) was used to test olfactory identification. Data were analyzed using the one‑way analysis of variance, Kruskal‑Wallis or Mann‑Whitney tests.


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Study Type : Observational [Patient Registry]
Actual Enrollment : 600 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Official Title: Evaluation of Neurotoxic Effect of Sevoflurane‑Based Anaesthesia Guided by Significant Short‑Term Olfactory Identification Impairment in Old Age
Actual Study Start Date : March 1, 2017
Actual Primary Completion Date : September 1, 2018
Actual Study Completion Date : October 1, 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
control group
regional anesthesia
general anesthesia(S)
general anesthesia with sevoflurane
Drug: Sevoflurane
Assess the effect of isoflurane, sevoflurane, propofol and regional anesthesia on the olfactory threshold, olfactory identification and endocrine regulation of associative memory in the postoperative period in old age group.
Other Names:
  • Isoflurane
  • Propofol

general anesthesia(I)
general anesthesia with isoflurane
total intravenous anesthesia
total intravenous anesthesia with propofol.



Primary Outcome Measures :
  1. The changes in Mini-Mental State Examination (MMSE) [ Time Frame: basically at 12 hours preoperatively (T0), then 3 hours postoperatively (T1) and at the time of discharge or postoperative 3 days (T2) ]
    Cognitive function evaluated by MMSE scores. The Mini-Mental State Examination (MMSE) or Folstein test is a 30-point questionnaire that is used extensively in clinical and research settings to measure cognitive impairment. It is commonly used in medicine and allied health to screen for dementia.

  2. The changes in olfactory threshold [ Time Frame: basically at 12 hours preoperatively (T0), then 3 hours postoperatively (T1) and at the time of discharge or postoperative 3 days (T2) ]
    Was measured using serial dilutions (10 dilutions) of 4% n‑butyl alcohol in deionized water. The test consists of 10 steps. In each step, the odorant and a blank were presented to the participant. The test progressed from weaker‑to‑stronger concentrations of odorant. Two bottles were presented to each participant, an odorant bottle and an identical bottle filled with distilled water. The participant sniffed each one for approximately 9 s and then chose which one smelled stronger. If the participant was incorrect at one concentration, the next higher concentration was presented. When the correct choice was made, the same concentration of odorant was presented to the participant until four consecutive correct responses were given. The threshold was defined as the butyl alcohol concentration correctly chosen over water in four consecutive trials, and the corresponding number of the concentration was taken as the threshold value.

  3. The changes in olfactory identification [ Time Frame: basically at 12 hours preoperatively (T0), then 3 hours postoperatively (T1) and at the time of discharge or postoperative3 days (T2) ]
    Was assessed using the Pocket Smell TestTM series (PSTs). The test uses four booklets containing labels impregnated with odorous substances. The test is in multiple‑choice format, with four written response alternatives for each odor. The odors are released when the labels are scratched. The examiner scraped each target patch and instructed participants to smell the patch and then select the name of the released odor from among four alternatives. Olfactory identification tested using the (PSTs) assessed both the recent memory and the remote memory of the patient as it contained odors which were a mixture of both the familiar and unfamiliar ones to the study population. Here, it is not utilized to identify patients with anosmia or hyposmia. Instead, the (PSTs) is used as a linear, unbiased unidimensional Rasch measure of human smell recognition abilities.


Secondary Outcome Measures :
  1. The changes in olfactory melatonin levels [ Time Frame: serum melatonin levels were estimated basically at 12 hours preoperatively (T0), then 3 hours postoperatively (T1) and at the time of discharge or postoperative3 days (T2) ]
    Melatonin levels were measured in plasma by the enzyme‑linked immunosorbent assay (ELISA) (IBL, Hamburg, Germany).



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Ages Eligible for Study:   60 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Six hundred patients of both sex with inclusion following criteria: American Society of Anaesthesiologists I and II physical status aged from 60 to 75years scheduled for elective surgery with the anticipated duration of 100-120 min (surgical procedures included hernia repair, varicose vein surgery, incisional hernia repair, minor gynecological procedures, lower limb orthopedic procedures, and minor urological procedures)
Criteria

Inclusion Criteria:

  • American Society of Anaesthesiologists I and II physical status
  • aged from 60 to 75years
  • scheduled for elective surgery with the anticipated duration of 100-120 min.
  • surgical procedures included hernia repair,
  • varicose vein surgery,
  • incisional hernia repair,
  • minor gynecological procedures,
  • lower limb orthopedic procedures,
  • minor urological procedures

Exclusion Criteria:

  • Patients with recent airway infection,
  • allergic rhinitis,
  • nasal polyps,
  • history of alcoholism,
  • smoking,
  • mental retardation,
  • psychiatric illness,
  • neurosurgical or oto‑rhino‑laryngeal surgery
  • patients with a history of olfactory deficits and cognitive impairment

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 ClinicalTrials.gov identifier (NCT number): NCT03726580


Locations
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Egypt
Ahmed Said Elgebaly
Tanta, Egypt
Sponsors and Collaborators
Tanta University
Amer Galal Younis,MD
Investigators
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Study Director: ahmed S Elgebaly, MD Tanta University

Additional Information:

Publications of Results:

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Responsible Party: Ahmed Said Elgebaly,MD, director, Tanta University
ClinicalTrials.gov Identifier: NCT03726580     History of Changes
Other Study ID Numbers: TantaF
First Posted: October 31, 2018    Key Record Dates
Last Update Posted: October 31, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Ahmed Said Elgebaly,MD, Tanta University:
General anesthesia.
neurotoxicity,
olfaction,
olfactory identification.
sevoflurane.
Additional relevant MeSH terms:
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Neurotoxicity Syndromes
Nervous System Diseases
Poisoning
Chemically-Induced Disorders
Anesthetics
Propofol
Sevoflurane
Isoflurane
Central Nervous System Depressants
Physiological Effects of Drugs
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Platelet Aggregation Inhibitors
Anesthetics, Inhalation