Back to resultsThe Effects of Inhalational Anaesthetics in Cognitive Functions in Down Syndrome Patients
Primary Purpose
Down Syndrome
Status
Completed
Phase
Phase 2
Locations
Greece
Study Type
Interventional
Intervention
Sevoflurane
Desflurane
Sponsored by
About this trial
This is an interventional supportive care trial for Down Syndrome focused on measuring cognitive functions, anaesthesia recovery, sevoflurane, desflurane
Eligibility 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
Sites / Locations
- Gkliatis Emmanouil
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Sevoflurane group
Desflurane group
Arm Description
inhalation anaesthetic Sevoflurane, 1 M.A.C. during surgery
inhalation anaesthetic Desflurane, 1 M.A.C. during surgery
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Spontaneous breathing
Eye opening
Extubation
Orientation
Respond to commands
modified Aldrete Scoring System (mASS)
Orientation in PACU
Orientation in place, time and people in Post Operative Care Unit (PACU).
Orientation in PACU
Orientation in place, time and people in Post Operative Care Unit (PACU).
Antiemetics necessity.
Note if additional antiemetics was needed up to 4 hours postoperatively.
Painkillers necessity.
Note if additional painkillers was needed up to 4 hours postoperatively.
Patient Alertness, Wellness, Energy
Assessment of the accompanying persons.
Patient Alertness, Wellness, Energy
Assessment of the accompanying persons.
Patient Alertness, Wellness, Energy
Assessment of the accompanying persons.
Patient satisfaction over anaesthesia.
Assessment of the accompanying persons.
Postanesthesia Discharge Scoring System (PADSS)
Full Information
NCT ID
NCT02971254
First Posted
November 11, 2016
Last Updated
June 6, 2020
Sponsor
Asklepieion Voulas General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02971254
Brief Title
The Effects of Inhalational Anaesthetics in Cognitive Functions in Down Syndrome Patients
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
December 1, 2016 (Actual)
Primary Completion Date
January 6, 2019 (Actual)
Study Completion Date
May 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Asklepieion Voulas General Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Recovery of the cognitive functions and recovery features after general anaesthesia in Down syndrome patients. A comparison of Sevoflurane and Desflurane.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Down Syndrome
Keywords
cognitive functions, anaesthesia recovery, sevoflurane, desflurane
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
39 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sevoflurane group
Arm Type
Active Comparator
Arm Description
inhalation anaesthetic Sevoflurane, 1 M.A.C. during surgery
Arm Title
Desflurane group
Arm Type
Active Comparator
Arm Description
inhalation anaesthetic Desflurane, 1 M.A.C. during surgery
Intervention Type
Drug
Intervention Name(s)
Sevoflurane
Intervention Type
Drug
Intervention Name(s)
Desflurane
Primary Outcome Measure Information:
Title
Change in Cognitive Functions
Description
Quantitative result measured by Prudhoe Cognitive Function Test (PCFT), a scale to assess cognitive function in adults with Down's syndrome.
Time Frame
Baseline (12 to 24 hours before surgery), 1,5 hours after surgery and 4 hours after surgery
Secondary Outcome Measure Information:
Title
Spontaneous breathing
Time Frame
Interval between discontinuation of inhaled agent and first spontaneous breath and up to 1 hour.
Title
Eye opening
Time Frame
Interval between discontinuation of inhaled agent and first eye opening and up to 1 hour.
Title
Extubation
Time Frame
Interval between discontinuation of inhaled agent and extubation and up to 1 hour.
Title
Orientation
Time Frame
Interval between discontinuation of inhaled agent and orientation in place, time, people and up to 1 hour.
Title
Respond to commands
Time Frame
Interval between discontinuation of inhaled agent and respond to commands and up to 1 hour.
Title
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.
Title
Orientation in PACU
Description
Orientation in place, time and people in Post Operative Care Unit (PACU).
Time Frame
30 minutes after PACU entrance
Title
Orientation in PACU
Description
Orientation in place, time and people in Post Operative Care Unit (PACU).
Time Frame
60 minutes after PACU entrance
Title
Antiemetics necessity.
Description
Note if additional antiemetics was needed up to 4 hours postoperatively.
Time Frame
Interval between entrance in PACU and administer antiemetic medication and up to 4 hours.
Title
Painkillers necessity.
Description
Note if additional painkillers was needed up to 4 hours postoperatively.
Time Frame
Interval between entrance in PACU and administration of antiemetic medication and up to 4 hours.
Title
Patient Alertness, Wellness, Energy
Description
Assessment of the accompanying persons.
Time Frame
Baseline, 12 to 24 hours before surgery
Title
Patient Alertness, Wellness, Energy
Description
Assessment of the accompanying persons.
Time Frame
1,5 hours after surgery
Title
Patient Alertness, Wellness, Energy
Description
Assessment of the accompanying persons.
Time Frame
4 hours after surgery
Title
Patient satisfaction over anaesthesia.
Description
Assessment of the accompanying persons.
Time Frame
4 hours after surgery
Title
Postanesthesia Discharge Scoring System (PADSS)
Time Frame
Fulfillment of the criteria of PADSS from discontinuation of inhaled agent and up to 1 day.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emmanouil Gkliatis, MD
Organizational Affiliation
GH Asklepieio Voulas
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gkliatis Emmanouil
City
Athens
Country
Greece
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
34535086
Citation
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.
Results Reference
derived
Learn more about this trial
The Effects of Inhalational Anaesthetics in Cognitive Functions in Down Syndrome Patients
We'll reach out to this number within 24 hrs