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

NCT ID: NCT02971254

Last Updated: 2020-06-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-01

Study Completion Date

2019-05-30

Brief Summary

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

Detailed Description

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Conditions

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Down Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Sevoflurane group

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

Group Type ACTIVE_COMPARATOR

Sevoflurane

Intervention Type DRUG

Desflurane group

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

Group Type ACTIVE_COMPARATOR

Desflurane

Intervention Type DRUG

Interventions

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Sevoflurane

Intervention Type DRUG

Desflurane

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Asklepieion Voulas General Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Gkliatis Emmanouil

Anaesthetist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Emmanouil Gkliatis, MD

Role: PRINCIPAL_INVESTIGATOR

GH Asklepieio Voulas

Locations

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Gkliatis Emmanouil

Athens, , Greece

Site Status

Countries

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Greece

References

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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.

Reference Type DERIVED
PMID: 34535086 (View on PubMed)

Other Identifiers

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8174

Identifier Type: -

Identifier Source: org_study_id

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