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

NCT02971254 | Completed Phase 2

• 1 other identifier: 8174
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Down Syndrome

Keywords

cognitive functions; anaesthesia recovery; sevoflurane; desflurane

Outcome Measures

Primary Outcomes (1)

• Change in Cognitive Functions

  Quantitative result measured by Prudhoe Cognitive Function Test (PCFT), a scale to assess cognitive function in adults with Down's syndrome.

  Baseline (12 to 24 hours before surgery), 1,5 hours after surgery and 4 hours after surgery

Secondary Outcomes (15)

• Spontaneous breathing

  Interval between discontinuation of inhaled agent and first spontaneous breath and up to 1 hour.

• Eye opening

  Interval between discontinuation of inhaled agent and first eye opening and up to 1 hour.

• Extubation

  Interval between discontinuation of inhaled agent and extubation and up to 1 hour.

• Orientation

  Interval between discontinuation of inhaled agent and orientation in place, time, people and up to 1 hour.

• Respond to commands

  Interval between discontinuation of inhaled agent and respond to commands and up to 1 hour.

Study Arms (2)

Sevoflurane group

ACTIVE COMPARATOR

inhalation anaesthetic Sevoflurane, 1 M.A.C. during surgery

Drug: Sevoflurane

Desflurane group

ACTIVE COMPARATOR

inhalation anaesthetic Desflurane, 1 M.A.C. during surgery

Drug: Desflurane

Interventions

Sevoflurane DRUG

Sevoflurane group

Desflurane DRUG

Desflurane group

Eligibility Criteria

• Age: 16 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• severe dementia
• severe hearing, vision, speaking problems

Sponsors & Collaborators

• Asklepieion Voulas General Hospital: lead

Study Sites (1)

Gkliatis Emmanouil

Athens, Greece

Location

Related Publications (1)

• Gkliatis E, Makris A, Staikou C. The impact of inhalation anesthetics on early postoperative cognitive function and recovery characteristics in Down syndrome patients: a randomized, double - blind study. BMC Anesthesiol. 2021 Sep 17;21(1):227. doi: 10.1186/s12871-021-01447-x.

  PMID: 34535086 DERIVED

MeSH Terms

Conditions

Down Syndrome

Interventions

Sevoflurane; Desflurane

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Methyl Ethers; Ethers; Organic Chemicals; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Ethyl Ethers

Study Officials

• Emmanouil Gkliatis, MD

  GH Asklepieio Voulas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anaesthetist

Study Record Dates

• First Submitted: November 11, 2016
• First Posted: November 22, 2016
• Study Start: December 1, 2016
• Primary Completion: January 6, 2019
• Study Completion: May 30, 2019
• Last Updated: June 9, 2020

Record last verified: 2020-06

Locations

GR (1)