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

Phase 2

Completed

• Conditions: Down Syndrome
• Interventions: Drug: Sevoflurane; Drug: Desflurane

• Registration Number: NCT02971254
• Lead Sponsor: Asklepieion Voulas General Hospital

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-11-11
• Study First Submitted QC: 2016-11-21
• Study First Posted: 2016-11-22
• Study Start: 2016-12-01
• Primary Completion: 2019-01-06
• Study Completion: 2019-05-30
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-06
• Last Update Posted: 2020-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sevoflurane group	Sevoflurane	inhalation anaesthetic Sevoflurane, 1 M.A.C. during surgery
Desflurane group	Desflurane	inhalation anaesthetic Desflurane, 1 M.A.C. during surgery

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Extubation	Interval between discontinuation of inhaled agent and extubation 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.
Patient Alertness, Wellness, Energy	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	60 minutes after PACU entrance	Orientation in place, time and people in Post Operative Care Unit (PACU).
Patient satisfaction over anaesthesia.	4 hours after surgery	Assessment of the accompanying persons.
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.
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.
Eye opening	Interval between discontinuation of inhaled agent and first eye opening and up to 1 hour.
Orientation	Interval between discontinuation of inhaled agent and orientation in place, time, people and up to 1 hour.
Spontaneous breathing	Interval between discontinuation of inhaled agent and first spontaneous breath and up to 1 hour.

Trial Locations

Locations (1)

Gkliatis Emmanouil; 🇬🇷 Athens, Greece