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The Effects of Inhalational Anaesthetics in Cognitive Functions in Down Syndrome Patients

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ClinicalTrials.gov Identifier: NCT02971254
Recruitment Status : Recruiting
First Posted : November 22, 2016
Last Update Posted : July 19, 2017
Sponsor:
Information provided by (Responsible Party):
Gkliatis Emmanouil, Asklepieion Voulas General Hospital

Brief Summary:
Recovery of the cognitive functions and recovery features after general anaesthesia in Down syndrome patients. A comparison of Sevoflurane and Desflurane.

Condition or disease Intervention/treatment Phase
Down Syndrome Drug: Sevoflurane Drug: Desflurane Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 39 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Study Start Date : April 2013
Estimated Primary Completion Date : November 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Sevoflurane group
inhalation anaesthetic Sevoflurane, 1 M.A.C. during surgery
Drug: Sevoflurane
Active Comparator: Desflurane group
inhalation anaesthetic Desflurane, 1 M.A.C. during surgery
Drug: Desflurane



Primary Outcome Measures :
  1. Change in Cognitive Functions [ Time Frame: Baseline (12 to 24 hours before surgery), 1,5 hours after surgery and 4 hours after surgery ]
    Quantitative result measured by Prudhoe Cognitive Function Test (PCFT), a scale to assess cognitive function in adults with Down's syndrome.


Secondary Outcome Measures :
  1. Spontaneous breathing [ Time Frame: Interval between discontinuation of inhaled agent and first spontaneous breath and up to 1 hour. ]
  2. Eye opening [ Time Frame: Interval between discontinuation of inhaled agent and first eye opening and up to 1 hour. ]
  3. Extubation [ Time Frame: Interval between discontinuation of inhaled agent and extubation and up to 1 hour. ]
  4. Orientation [ Time Frame: Interval between discontinuation of inhaled agent and orientation in place, time, people and up to 1 hour. ]
  5. Respond to commands [ Time Frame: Interval between discontinuation of inhaled agent and respond to commands and up to 1 hour. ]
  6. modified Aldrete Scoring System (mASS) [ Time Frame: Interval between entrance in Post Operative Care Unit (PACU) and fulfillment of the criteria mASS to discharge PACU and up to 2 hours. ]
  7. Orientation in PACU [ Time Frame: 30 minutes after PACU entrance ]
    Orientation in place, time and people in Post Operative Care Unit (PACU).

  8. Orientation in PACU [ Time Frame: 60 minutes after PACU entrance ]
    Orientation in place, time and people in Post Operative Care Unit (PACU).

  9. Antiemetics necessity. [ Time Frame: Interval between entrance in PACU and administer antiemetic medication and up to 4 hours. ]
    Note if additional antiemetics was needed up to 4 hours postoperatively.

  10. Painkillers necessity. [ Time Frame: Interval between entrance in PACU and administration of antiemetic medication and up to 4 hours. ]
    Note if additional painkillers was needed up to 4 hours postoperatively.

  11. Patient Alertness, Wellness, Energy [ Time Frame: Baseline, 12 to 24 hours before surgery ]
    Assessment of the accompanying persons.

  12. Patient Alertness, Wellness, Energy [ Time Frame: 1,5 hours after surgery ]
    Assessment of the accompanying persons.

  13. Patient Alertness, Wellness, Energy [ Time Frame: 4 hours after surgery ]
    Assessment of the accompanying persons.

  14. Patient satisfaction over anaesthesia. [ Time Frame: 4 hours after surgery ]
    Assessment of the accompanying persons.

  15. Postanesthesia Discharge Scoring System (PADSS) [ Time Frame: Fulfillment of the criteria of PADSS from discontinuation of inhaled agent and up to 1 day. ]


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Ages Eligible for Study:   16 Years to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • American Society of Anesthesiologists (ASA) classification I, II or III
  • Down syndrome patients
  • must be able to undergone general anaesthesia
  • dental surgery necessity

Exclusion Criteria:

  • severe dementia
  • severe hearing, vision, speaking problems

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): NCT02971254


Contacts
Contact: Emmanouil Gkliatis, MD 00306973306141 emmgliatis@yahoo.com

Locations
Greece
Gkliatis Emmanouil Recruiting
Athens, Greece
Contact: Emmanouil Gkliatis, MD    00306973306141    emmgliatis@yahoo.com   
Contact: Alexandros Makris, MD, MSc, PhD    00306947076446    makrisalexandros@hotmail.com   
Sponsors and Collaborators
Asklepieion Voulas General Hospital
Investigators
Principal Investigator: Emmanouil Gkliatis, MD GH Asklepieio Voulas

Responsible Party: Gkliatis Emmanouil, Anaesthetist, Asklepieion Voulas General Hospital
ClinicalTrials.gov Identifier: NCT02971254     History of Changes
Other Study ID Numbers: 8174/24.04.2013
First Posted: November 22, 2016    Key Record Dates
Last Update Posted: July 19, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Gkliatis Emmanouil, Asklepieion Voulas General Hospital:
cognitive functions
anaesthesia recovery
sevoflurane
desflurane

Additional relevant MeSH terms:
Intellectual Disability
Syndrome
Down Syndrome
Disease
Pathologic Processes
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Abnormalities, Multiple
Congenital Abnormalities
Chromosome Disorders
Genetic Diseases, Inborn
Anesthetics
Sevoflurane
Desflurane
Isoflurane
Central Nervous System Depressants
Physiological Effects of Drugs
Platelet Aggregation Inhibitors
Anesthetics, Inhalation
Anesthetics, General