Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Recovery of the cognitive functions and recovery features after general anaesthesia in Down syndrome patients. A comparison of Sevoflurane and Desflurane.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sevoflurane group | Active Comparator | inhalation anaesthetic Sevoflurane, 1 M.A.C. during surgery |
|
| Desflurane group | Active Comparator | inhalation anaesthetic Desflurane, 1 M.A.C. during surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sevoflurane | Drug |
| ||
| Desflurane |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline (12 to 24 hours before surgery), 1,5 hours after surgery and 4 hours after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Spontaneous breathing | Interval between discontinuation of inhaled agent and first spontaneous breath and up to 1 hour. | |
| Eye opening | Interval between discontinuation of inhaled agent and first eye opening and up to 1 hour. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Emmanouil Gkliatis, MD | GH Asklepieio Voulas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gkliatis Emmanouil | Athens | Greece |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34535086 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D004314 | Down Syndrome |
| ID | Term |
|---|---|
| D008607 | Intellectual Disability |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077149 | Sevoflurane |
| D000077335 | Desflurane |
| ID | Term |
|---|---|
| D008738 | Methyl Ethers |
| D004987 | Ethers |
| D009930 | Organic Chemicals |
| D006845 | Hydrocarbons, Fluorinated |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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. |
| Orientation in PACU | Orientation in place, time and people in Post Operative Care Unit (PACU). | 30 minutes after PACU entrance |
| Orientation in PACU | Orientation in place, time and people in Post Operative Care Unit (PACU). | 60 minutes after PACU entrance |
| Antiemetics necessity. | Note if additional antiemetics was needed up to 4 hours postoperatively. | 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. | Interval between entrance in PACU and administration of antiemetic medication and up to 4 hours. |
| Patient Alertness, Wellness, Energy | Assessment of the accompanying persons. | Baseline, 12 to 24 hours before surgery |
| Patient Alertness, Wellness, Energy | Assessment of the accompanying persons. | 1,5 hours after surgery |
| Patient Alertness, Wellness, Energy | Assessment of the accompanying persons. | 4 hours after surgery |
| Patient satisfaction over anaesthesia. | Assessment of the accompanying persons. | 4 hours after surgery |
| Postanesthesia Discharge Scoring System (PADSS) | Fulfillment of the criteria of PADSS from discontinuation of inhaled agent and up to 1 day. |
| D000015 | Abnormalities, Multiple |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D025063 | Chromosome Disorders |
| D030342 | Genetic Diseases, Inborn |
| D006846 |
| Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D005019 | Ethyl Ethers |