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

Sponsor

Asklepieion Voulas General Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT02971254

Collaborator

(none)

Enrollment

Location

Arms

29.9

Actual Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Down Syndrome	Drug: Sevoflurane Drug: Desflurane	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

39 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Supportive Care

Actual Study Start Date :

Dec 1, 2016

Actual Primary Completion Date :

Jan 6, 2019

Actual Study Completion Date :

May 30, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Sevoflurane group inhalation anaesthetic Sevoflurane, 1 M.A.C. during surgery	Drug: Sevoflurane
Active Comparator: Desflurane group inhalation anaesthetic Desflurane, 1 M.A.C. during surgery	Drug: Desflurane

Arm

Intervention/Treatment

Active Comparator: Sevoflurane group

inhalation anaesthetic Sevoflurane, 1 M.A.C. during surgery

Drug: Sevoflurane

Active Comparator: Desflurane group

inhalation anaesthetic Desflurane, 1 M.A.C. during surgery

Drug: Desflurane

Outcome Measures

Primary Outcome Measures

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

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 [30 minutes after PACU entrance]
Orientation in place, time and people in Post Operative Care Unit (PACU).
Orientation in PACU [60 minutes after PACU entrance]
Orientation in place, time and people in Post Operative Care Unit (PACU).
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 Alertness, Wellness, Energy [1,5 hours after surgery]
Assessment of the accompanying persons.
Patient Alertness, Wellness, Energy [4 hours after 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.]