Down Syndrome
Conditions
Keywords
cognitive functions, anaesthesia recovery, sevoflurane, desflurane
Brief summary
Recovery of the cognitive functions and recovery features after general anaesthesia in Down syndrome patients. A comparison of Sevoflurane and Desflurane.
Interventions
DRUGSevoflurane
DRUGDesflurane
Sponsors
Asklepieion Voulas General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
16 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Cognitive Functions | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | — |
| modified Aldrete Scoring System (mASS) | Interval between entrance in Post Operative Care Unit (PACU) and fulfillment of the criteria mASS to discharge PACU and up to 2 hours. | — |
| Spontaneous breathing | Interval between discontinuation of inhaled agent and first spontaneous breath and up to 1 hour. | — |
| Antiemetics necessity. | Interval between entrance in PACU and administer antiemetic medication and up to 4 hours. | Note if additional antiemetics was needed up to 4 hours postoperatively. |
| Painkillers necessity. | Interval between entrance in PACU and administration of antiemetic medication and up to 4 hours. | Note if additional painkillers was needed up to 4 hours postoperatively. |
| Patient Alertness, Wellness, Energy | Baseline, 12 to 24 hours before surgery | Assessment of the accompanying persons. |
| Patient satisfaction over anaesthesia. | 4 hours after surgery | Assessment of the accompanying persons. |
| Postanesthesia Discharge Scoring System (PADSS) | Fulfillment of the criteria of PADSS from discontinuation of inhaled agent and up to 1 day. | — |
| Orientation in PACU | 30 minutes after PACU entrance | Orientation in place, time and people in Post Operative Care Unit (PACU). |
Countries
Greece
Outcome results
None listed