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

October 30, 2018 updated by: Ahmed Said Elgebaly,MD, Tanta University

Evaluation of Neurotoxic Effect of Sevoflurane-Based Anaesthesia Guided by Significant Short-Term Olfactory Identification Impairment in Old Age

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Tanta, Egypt
        • Ahmed Said Elgebaly

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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)

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

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:
  • Propofol
  • Isoflurane
general anesthesia(I)
general anesthesia with isoflurane
total intravenous anesthesia
total intravenous anesthesia with propofol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
basically at 12 hours preoperatively (T0), then 3 hours postoperatively (T1) and at the time of discharge or postoperative 3 days (T2)
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.
basically at 12 hours preoperatively (T0), then 3 hours postoperatively (T1) and at the time of discharge or postoperative 3 days (T2)
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.
basically at 12 hours preoperatively (T0), then 3 hours postoperatively (T1) and at the time of discharge or postoperative3 days (T2)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tanta University

Collaborators

Amer Galal Younis,MD

Investigators

  • Study Director: ahmed S Elgebaly, MD, Tanta University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2017

Primary Completion (Actual)

September 1, 2018

Study Completion (Actual)

October 1, 2018

Study Registration Dates

First Submitted

October 29, 2018

First Submitted That Met QC Criteria

October 30, 2018

First Posted (Actual)

October 31, 2018

Study Record Updates

Last Update Posted (Actual)

November 1, 2018

Last Update Submitted That Met QC Criteria

October 30, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TantaF

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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