A Phase 2 interventional study of Sevoflurane and Desflurane in Down Syndrome, sponsored by Asklepieion Voulas General Hospital. Completed at 1 site in Greece. Open to participants aged 16 Years to 75 Years. Per ClinicalTrials.gov, last updated 2020-06-09.
Sponsored by Asklepieion Voulas General Hospital · Phase 2, Interventional, and Supportive care
Recovery of the cognitive functions and recovery features after general anaesthesia in Down syndrome patients. A comparison of Sevoflurane and Desflurane.
438 studies on the registry are indexed under Down Syndrome; 99 are open to participants now.
This study's enrollment of 39 is close to the median of 37 across 286 interventional studies indexed under Down Syndrome.
Browse Down Syndrome studies →Asklepieion Voulas General Hospital is the lead sponsor of 13 studies on the registry; 1 is open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
inhalation anaesthetic Sevoflurane, 1 M.A.C. during surgery
Drug: Sevoflurane
inhalation anaesthetic Desflurane, 1 M.A.C. during surgery
Drug: Desflurane
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.
Time frame: Baseline (12 to 24 hours before surgery), 1,5 hours after surgery and 4 hours after surgery
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
Orientation in place, time and people in Post Operative Care Unit (PACU).
Time frame: 30 minutes after PACU entrance
Orientation in PACU
Orientation in place, time and people in Post Operative Care Unit (PACU).
Time frame: 60 minutes after PACU entrance
Antiemetics necessity.
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.
Painkillers necessity.
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.
Patient Alertness, Wellness, Energy
Assessment of the accompanying persons.
Time frame: Baseline, 12 to 24 hours before surgery
Patient Alertness, Wellness, Energy
Assessment of the accompanying persons.
Time frame: 1,5 hours after surgery
Patient Alertness, Wellness, Energy
Assessment of the accompanying persons.
Time frame: 4 hours after surgery
Patient satisfaction over anaesthesia.
Assessment of the accompanying persons.
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.
Plan to share: Undecided
Ran from Dec 2016 to primary completion in Jan 2019, 25 months.
Of 21 phase 2 interventional studies under Down Syndrome, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 26 and three quarters within 61. This study's 25 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Sevoflurane · Desflurane
Asklepieion Voulas General Hospital