Procedural deep sedation (gastrointestinal endoscopy, lumbar puncture, etc) MedDRA version: 9.1 Level: LLT Classification code 10002091 Term: Anaesthesia
Conditions
Interventions
Trade Name: KETANEST S
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Ketamine
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Pharmaceutical
Sponsors
ISTITUTO PER L'INFANZIA BURLO GAROFOLO
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ASA (American Society of Anesthesiology)1 and 2 children (1-18 years) scheduled for elective deep sedation for diagnostic procedures Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Children ASA 3 and more, presence of risk factors for loss of airway patency.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To asses safety and efficacy of two different strategies of deep sedation managed by non anesthesiologists. Number of sedations successfully performed, side effects.;Secondary Objective: To evaluate quality of sedation (pain during propofol injection, recovery time, characteristics of arousal, post-sedation vomiting), reduction in propofol dosage/kg, costs.;Primary end point(s): Number of sedations successfully managed, number and severity of fall in arterial oxygen saturation. | — |
Countries
Italy
Outcome results
None listed