Down SyndromePhase 2NCT02971254
The Effects of Inhalational Anaesthetics in Cognitive Functions in Down Syndrome Patients
A Phase 2 study testing Sevoflurane and Desflurane in people with Down Syndrome, run by Asklepieion Voulas General Hospital at 1 site in Greece.
Trial summary
Recovery of the cognitive functions and recovery features after general anaesthesia in Down syndrome patients. A comparison of Sevoflurane and Desflurane. Read more about this study
- Who is it for?
- Ages 16 to 75 years
- Conditions the study is for
- Down Syndrome
- What is being tested?
- Sevoflurane and Desflurane
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteGreece
- Study dates
- 1 Dec 2016to 30 May 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists (ASA) classification I, II or III
- Down syndrome patients
- must be able to undergone general anaesthesia
- dental surgery necessity
Who cannot join
- severe dementia
- severe hearing, vision, speaking problems
Trial locations and contacts
1 site in 1 country.
About this study
Recovery of the cognitive functions and recovery features after general anaesthesia in Down syndrome patients. A comparison of Sevoflurane and Desflurane.
- Conditions
- Down Syndrome
- Being tested
- Sevoflurane, Desflurane
- Keywords
- cognitive functions, anaesthesia recovery, sevoflurane, desflurane
- Medical subject headings
- Down Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SevofluraneDrug
DesfluraneDrug
| Study group | Role | What they receive |
|---|---|---|
| Sevoflurane group | Active comparator | inhalation anaesthetic Sevoflurane, 1 M.A.C. during surgery Receives: Drug: Sevoflurane |
| Desflurane group | Active comparator | inhalation anaesthetic Desflurane, 1 M.A.C. during surgery Receives: Drug: Desflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (12 to 24 hours before surgery), 1,5 hours after surgery and 4 hours after surgery
Secondary outcomes (15)
Spontaneous breathing
Measured: Interval between discontinuation of inhaled agent and first spontaneous breath and up to 1 hour.
Eye opening
Measured: Interval between discontinuation of inhaled agent and first eye opening and up to 1 hour.
Extubation
Measured: Interval between discontinuation of inhaled agent and extubation and up to 1 hour.
Orientation
Measured: Interval between discontinuation of inhaled agent and orientation in place, time, people and up to 1 hour.
Respond to commands
Measured: Interval between discontinuation of inhaled agent and respond to commands and up to 1 hour.
modified Aldrete Scoring System (mASS)
Measured: Interval between entrance in Post Operative Care Unit (PACU) and fulfillment of the criteria mASS to discharge PACU and up to 2 hours.
Orientation in PACU
Orientation in place, time and people in Post Operative Care Unit (PACU).
Measured: 30 minutes after PACU entrance
Orientation in PACU
Orientation in place, time and people in Post Operative Care Unit (PACU).
Measured: 60 minutes after PACU entrance
Antiemetics necessity.
Note if additional antiemetics was needed up to 4 hours postoperatively.
Measured: Interval between entrance in PACU and administer antiemetic medication and up to 4 hours.
Painkillers necessity.
Note if additional painkillers was needed up to 4 hours postoperatively.
Measured: Interval between entrance in PACU and administration of antiemetic medication and up to 4 hours.
Patient Alertness, Wellness, Energy
Assessment of the accompanying persons.
Measured: Baseline, 12 to 24 hours before surgery
Patient Alertness, Wellness, Energy
Assessment of the accompanying persons.
Measured: 1,5 hours after surgery
Patient Alertness, Wellness, Energy
Assessment of the accompanying persons.
Measured: 4 hours after surgery
Patient satisfaction over anaesthesia.
Assessment of the accompanying persons.
Measured: 4 hours after surgery
Postanesthesia Discharge Scoring System (PADSS)
Measured: Fulfillment of the criteria of PADSS from discontinuation of inhaled agent and up to 1 day.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2016 (estimated)
- Study start1 Dec 2016
- Primary completion6 Jan 2019
- Study completion30 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Down SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asklepieion Voulas General Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Gkliatis Emmanouil, Asklepieion Voulas General Hospital
- Investigators
- Emmanouil Gkliatis, MD, Principal investigator, GH Asklepieio Voulas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02971254
- Sponsor's protocol ID
- 8174
- Status last verified
- Jun 2020
- First submitted
- 11 Nov 2016
- Last updated
- 9 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 34535086
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Inhalational Anaesthetics in Cognitive Functions in Down Syndrome Patients
- ClinicalTrials.gov ID
- NCT02971254
- Acronym / sponsor ID
- 8174
- Conditions
- Down Syndrome
- Keywords
- cognitive functions, anaesthesia recovery, sevoflurane, desflurane
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Asklepieion Voulas General HospitalOther government
- Study start
- 1 Dec 2016 (actual)
- Primary completion
- 6 Jan 2019 (actual)
- Study completion
- 30 May 2019 (actual)
- First posted
- 22 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Recovery of the cognitive functions and recovery features after general anaesthesia in Down syndrome patients. A comparison of Sevoflurane and Desflurane.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sevoflurane group | Active comparator | Drug: Sevofluraneinhalation anaesthetic Sevoflurane, 1 M.A.C. during surgery |
| Desflurane group | Active comparator | Drug: Desfluraneinhalation anaesthetic Desflurane, 1 M.A.C. during surgery |
Who may qualify
- Ages
- 16 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- American Society of Anesthesiologists (ASA) classification I, II or III
- Down syndrome patients
- must be able to undergone general anaesthesia
- dental surgery necessity
Key exclusion criteria (2 listed)
- severe dementia
- severe hearing, vision, speaking problems
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sevoflurane | Drug | Sevoflurane group |
| Desflurane | Drug | Desflurane group |
Primary outcome
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.
15 secondary outcomes
Spontaneous breathing
Time frame: Interval between discontinuation of inhaled agent and first spontaneous breath and up to 1 hour.
Eye opening
Time frame: Interval between discontinuation of inhaled agent and first eye opening and up to 1 hour.
Extubation
Time frame: Interval between discontinuation of inhaled agent and extubation and up to 1 hour.
Orientation
Time frame: Interval between discontinuation of inhaled agent and orientation in place, time, people and up to 1 hour.
Respond to commands
Time frame: Interval between discontinuation of inhaled agent and respond to commands and up to 1 hour.
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.
Orientation in PACU
Time frame: 30 minutes after PACU entrance
Orientation in PACU
Time frame: 60 minutes after PACU entrance
Antiemetics necessity.
Time frame: Interval between entrance in PACU and administer antiemetic medication and up to 4 hours.
Painkillers necessity.
Time frame: Interval between entrance in PACU and administration of antiemetic medication and up to 4 hours.
Patient Alertness, Wellness, Energy
Time frame: Baseline, 12 to 24 hours before surgery
Patient Alertness, Wellness, Energy
Time frame: 1,5 hours after surgery
Patient Alertness, Wellness, Energy
Time frame: 4 hours after surgery
Patient satisfaction over anaesthesia.
Time frame: 4 hours after surgery
Postanesthesia Discharge Scoring System (PADSS)
Time frame: Fulfillment of the criteria of PADSS from discontinuation of inhaled agent and up to 1 day.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2020.
- Derived from this study: PubMed 34535086Gkliatis 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emmanouil Gkliatis, MD principal investigator
GH Asklepieio Voulas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sevoflurane and Desflurane in people with Down Syndrome, run by Asklepieion Voulas General Hospital at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Cognitive Functions (time frame: Baseline (12 to 24 hours before surgery), 1,5 hours after surgery and 4 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02971254, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2020.