Clinical trial NCT02971254: The Effects of Inhalational Anaesthetics in Cognitive Functions in Down Syndrome Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Down Syndrome
Keywords: cognitive functions
anaesthesia recovery
sevoflurane
desflurane
Lead sponsor: Asklepieion Voulas General Hospital
Sponsor class: OTHER_GOV
First posted: 2016-11-22
Enrollment: 39
Sex: ALL
Minimum age (years): 16
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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


Eligibility criteria: 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

Primary outcomes:
measure: Change in Cognitive Functions
timeFrame: Baseline (12 to 24 hours before surgery), 1,5 hours after surgery and 4 hours after surgery
Secondary outcomes:
measure: Spontaneous breathing
timeFrame: Interval between discontinuation of inhaled agent and first spontaneous breath and up to 1 hour.
measure: Eye opening
timeFrame: Interval between discontinuation of inhaled agent and first eye opening and up to 1 hour.
measure: Extubation
timeFrame: Interval between discontinuation of inhaled agent and extubation and up to 1 hour.
measure: Orientation
timeFrame: Interval between discontinuation of inhaled agent and orientation in place, time, people and up to 1 hour.
measure: Respond to commands
timeFrame: Interval between discontinuation of inhaled agent and respond to commands and up to 1 hour.
measure: modified Aldrete Scoring System (mASS)
timeFrame: Interval between entrance in Post Operative Care Unit (PACU) and fulfillment of the criteria mASS to discharge PACU and up to 2 hours.
measure: Orientation in PACU
timeFrame: 30 minutes after PACU entrance
measure: Orientation in PACU
timeFrame: 60 minutes after PACU entrance
measure: Antiemetics necessity.
timeFrame: Interval between entrance in PACU and administer antiemetic medication and up to 4 hours.
measure: Painkillers necessity.
timeFrame: Interval between entrance in PACU and administration of antiemetic medication and up to 4 hours.
measure: Patient Alertness, Wellness, Energy
timeFrame: Baseline, 12 to 24 hours before surgery
measure: Patient Alertness, Wellness, Energy
timeFrame: 1,5 hours after surgery
measure: Patient Alertness, Wellness, Energy
timeFrame: 4 hours after surgery
measure: Patient satisfaction over anaesthesia.
timeFrame: 4 hours after surgery
measure: Postanesthesia Discharge Scoring System (PADSS)
timeFrame: Fulfillment of the criteria of PADSS from discontinuation of inhaled agent and up to 1 day.
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Gkliatis Emmanouil
Study officials:
affiliation: GH Asklepieio Voulas
name: Emmanouil Gkliatis, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.