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

Down Syndrome Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02971254
• Other study ID #: 8174
• Status: Completed
• Phase: Phase 2
• Start date: December 1, 2016
• Est. completion date: May 30, 2019

Study information

• Verified date: June 2020
• Source: Asklepieion Voulas General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: May 30, 2019
• Est. primary completion date: January 6, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Down Syndrome
• Syndrome

Intervention

Drug:
• Sevoflurane

• Desflurane

Locations

Country	Name	City	State
Greece	Gkliatis Emmanouil	Athens

Sponsors (1)

Lead Sponsor	Collaborator
Asklepieion Voulas General Hospital

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Spontaneous breathing		Interval between discontinuation of inhaled agent and first spontaneous breath and up to 1 hour.
Secondary	Eye opening		Interval between discontinuation of inhaled agent and first eye opening and up to 1 hour.
Secondary	Extubation		Interval between discontinuation of inhaled agent and extubation and up to 1 hour.
Secondary	Orientation		Interval between discontinuation of inhaled agent and orientation in place, time, people and up to 1 hour.
Secondary	Respond to commands		Interval between discontinuation of inhaled agent and respond to commands and up to 1 hour.
Secondary	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.
Secondary	Orientation in PACU	Orientation in place, time and people in Post Operative Care Unit (PACU).	30 minutes after PACU entrance
Secondary	Orientation in PACU	Orientation in place, time and people in Post Operative Care Unit (PACU).	60 minutes after PACU entrance
Secondary	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.
Secondary	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.
Secondary	Patient Alertness, Wellness, Energy	Assessment of the accompanying persons.	Baseline, 12 to 24 hours before surgery
Secondary	Patient Alertness, Wellness, Energy	Assessment of the accompanying persons.	1,5 hours after surgery
Secondary	Patient Alertness, Wellness, Energy	Assessment of the accompanying persons.	4 hours after surgery
Secondary	Patient satisfaction over anaesthesia.	Assessment of the accompanying persons.	4 hours after surgery
Secondary	Postanesthesia Discharge Scoring System (PADSS)		Fulfillment of the criteria of PADSS from discontinuation of inhaled agent and up to 1 day.