Is there a difference in anxiety- and sedation-level, and in anesthesia induction compliance between the preanesthetics included in study, in pediatric patients? Can we prevent and reduce anxiety without causing negative cardiorespiratory effects by selected preanesthetic included in study, in TIVA in pediatric patients? Does the preanesthetic used in this study prevent and/or reduce pain, vomiting, shivering, events of emergence delirium and maladaptive behaviors, without prolonging recovery?
Conditions
Interventions
Trade Name: Dexdor
Pharmaceutical Form: Concentrate and solvent for solution for infusion
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Nasal use
T
Sponsors
Norrbottens läns landsting
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Informed consent from both parents Both genders 2-6 years of age ASA I-II Elective ENT-surgery Weight: =30 kg Language: Swedish Are the trial subjects under 18? yes Number of subjects for this age range: 300 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: ASA > II Hypersensitive to study drug Resent surgery Failure of vital organs (heart, lung, liver, kidneys) Central nervous system disorder or mental retardation Psychotropic medical use
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The aim of this research is to compare three different preanesthetic medications (midazolam, clonidine and dexmedetomidine) in elective minor surgery under total intravenous anesthesia in pediatric patients for anxiolysis and sedation, hemodynamic stability and recovery profiles. ;Secondary Objective: To establish a compliant and adaptable preanesthetic treatment that is both safe and effective in children undergoing surgery under total intravenous anesthesia.;Primary end point(s): Effects of preanesthetic medication will be assessed with regard; -Level of preoperative anxiety -Level of preoperative sedation -Perioperative hemodynamic effects -Level of postoperative pain -Episodes of postoperative vomiting (POV) -Episodes of emergency delirium -Post-hospital behavioral changes ;Timepoint(s) of evaluation of this end point: When the last subject has been included in the study and the two-week follow-up period has passed, the study closes. Then data validation starts as well as the analysis of the primary endpoints. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): -Experience during venous cannulation -Anesthesia induction compliance -Consumption of intraoperative anesthetics and fluids -Level of postoperative anxiety -Level of postoperative sedation -Episodes of shivering -Consumption of analgesics and antiemetics -Time of discharge -Parents anxiety related to their child´s anesthesia ;Timepoint(s) of evaluation of this end point: When the last subject has been included in the study. Then data validation starts as well as the analysis of the sekundary endpoints. | — |
Countries
Sweden
Contacts
Public ContactMagnus Hultin
Norrbottens läns landsting
Outcome results
None listed