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Completed

NCT Number: NCT02971254

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

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

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Key information

Conditions

Down Syndrome Abnormalities, Multiple Chromosome Disorders Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Intellectual Disability Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations

Age range

16 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Gkliatis Emmanouil

Athens, Greece

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sevoflurane

Drug

Desflurane

Drug

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Asklepieion Voulas General Hospital

Other Gov

Registry information

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Nov 22, 2016
Registry last updated
Jun 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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