The Effects of Inhalational Anaesthetics in Cognitive Functions in Down Syndrome Patients

Study Overview
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Brief Summary
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Recovery of the cognitive functions and recovery features after general anaesthesia in Down syndrome patients. A comparison of Sevoflurane and Desflurane.

Conditions
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Down Syndrome

Intervention / Treatment
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* Drug: Sevoflurane
* Drug: Desflurane


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Sevoflurane group<br>inhalation anaesthetic Sevoflurane, 1 M.A.C. during surgery | Drug: Sevoflurane<br> <br> |
| Active Comparator: Desflurane group<br>inhalation anaesthetic Desflurane, 1 M.A.C. during surgery | Drug: Desflurane<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cognitive functions, anaesthesia recovery, sevoflurane, desflurane