Anesthesia
Conditions
Keywords
Administration route, Preanesthetic medication, Sedation
Brief summary
The study purpose is to compare the effect of different Administration Routes of Pediatric Premedication (including oral administration, intramuscular injection, rectal perfusion, intranasal).
Detailed description
In this study, 80 cases of surgical or otolaryngology children undergoing elective surgery were divided into four groups：oral administration group, intramuscular group, rectal infusion group, intranasal group depending on the route of administration before anesthesia. By observing the difference of sedative effects, postoperative recovery, and postoperative psychological behavior among the four groups,compare the effect of four pre-anesthetic administration routes.
Interventions
OTHEROral administration
Premedicate--Oral administration of a mixture at preoperative 30 minutes: ketamine 3 mg/kg, midazolam 0.5 mg/kg and atropine 0.02 mg/kg, plus 50% glucose solution to 0.5ml /kg.
OTHERIntramuscular injection
Premedicate--At preoperative 30 minutes intramuscular injection of atropine 0.02 mg/kg, 5 minutes before entering the operation room, intramuscular injection of ketamine 5 mg/kg.
OTHERRectal perfusion
Premedicate--At preoperative 30 minutes rectal infusion of midazolam 0.5mg/kg
OTHERDripping nose
Premedicate--At preoperative 30 minutes dripping nose of Imidazole valium 0.2 mg/kg
DRUGAnesthesia induction(midazolam,fentanyl,propofol,atracurium)
After entering the operation room ,all cases intravenous midazolam 0.05 mg/kg, fentanyl 3μg/kg, closed-loop target controlled infusion propofol and atracurium .
PROCEDUREIntubation
Intubation when the trachea-oesophageal fistula（TOF） value fell 15%, BIS value dropped to 40.
DRUGAnesthesia maintenance(midazolam,fentanyl,propofol,atracurium)
All cases intravenous midazolam 0.05 mg/kg, fentanyl 3μg/kg, closed-loop target controlled infusion propofol and atracurium .
Sponsors
Second Affiliated Hospital of Xi'an Jiaotong University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Years to 7 Years
Healthy volunteers
No
Inclusion criteria
* Informed consent of children's parents; * Children patient in pediatric surgery and E.N.T. department; * surgery time 1 \ 3 hours; * Aged between 1 and 7 years old; * American Society of Anesthesiologists (ASA)classification:class I\ II;
Exclusion criteria
* With cardiovascular and respiratory complications; * A history of the endocrine system; * A long history of application of sedative drugs; * Water and electrolyte balance disorder preoperatively; * Liver and kidney dysfunction; * Nervous system dysfunction; * High gastrointestinal obstruction; * Tracheoesophageal fistula, trachea foreign body, hiatal hernia, dysphagia; * Lung infection, atelectasis; * Congenital heart disease(CHD); * Severe malnutrition; * Traumatic or ischemia anoxic encephalopathy, high cranial pressure; * Anesthesia and surgery was conducted in 3 days;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sedation Score | Try to break away from family membersan，an expected average of 3 min；Successfully break away from the family members and accept the face mask and venipuncture，an expected average of 5 min |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hemodynamic and anesthetic depth monitoring (Heart rate, blood pressure, pulse oxygen saturation, bispectral index(BIS) | From premedication to 10 min after extubation up to 4 hours | Heart rate, blood pressure, pulse oxygen saturation, bispectral index(BIS) |
| Stress index monitoring (The concentration of Plasma cortisol and blood sugar) | From anesthesia induction to 10 min after the start of surgery up to 30 min | The concentration of Plasma cortisol and blood sugar |
| Postoperation recovery assess (Wake up agitation score (PAED)、Steward score 、Postoperative recovery score) | 10 min after extubation | Wake up agitation score (PAED)、Steward score 、Postoperative recovery score |
| Postoperative behavior assessment (Postoperative behavior scale (PHBQ) | 1 day after the operation，7 day after the operation | Postoperative behavior scale (PHBQ) |
Outcome results
None listed