Effect of Anesthesia in Discharge Time From Postanesthesia Care Unit, Effect of Anesthesia in Discharge Time From the Hospital, Effect of Anesthesia in Extubation Time, Effect of Anesthesia in Postoperative Adverse Events, Effect of Anesthesia in Postoperative Pain
Conditions
Brief summary
The investigators intend to study the safety and effectiveness of opioid free anesthesia compared to opioid anesthesia in ambulatory surgery in children, regarding postoperative pain, hemodynamic stability, agitation and discharge times. Quality of postanesthetic care was estimated in a 24h follow up.
Interventions
DRUGKetamine, dexmedetomidine
Patients will receive non-opioid analgesics, such as dexmedetomidine, ketamine perioperatively
DRUGfentanyl, remifentanil
Patients will receive opioid analgesics, such as fentanyl and remifentanil perioperatively
Sponsors
Athens General Children's Hospital Pan. & Aglaia Kyriakou
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
3 Years to 16 Years
Healthy volunteers
No
Inclusion criteria
* children, * American Society Anesthesia I, II, * ambulatory surgery
Exclusion criteria
* Allergy to anesthetic and analgesic drugs, * history of neuromuscular, * renal, neurological, hepatic disease, * craniofacial anomalies, * Obstructive Sleep Apnea, * obesity, * cardiopulmonary diseases
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Discharge times from the hospital | 4 hours | Comparison of the discharge times from the hospital between opioid free and opioid based anesthesia using Discharge criteria based on physiological scoring system, evaluating respiration, circulation, level of consciousness, postoperative pain, postoperative nausea and vomiting and surgical site. A score 12 or more allows patient to leave safely from the hospital. |
| Severity of postoperative pain | 24 hours | Comparison of the severity of postoperative pain between opioid free and opioid based anesthesia using Visual Analogue Scale for children aged 7 years and more. We instruct the patient to point to the position on the line between the faces to indicate how much pain they are currently feeling. The far left end indicates no pain(0) and the far right end indicates worst pain ever.(10) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Extubation time | 30 minutes | Comparison of extubation time, time interval between discontinuation of anesthetics and extubation between the two groups |
| Discharge time from PACU | 60 minutes | Comparison of discharge time from postanesthesia unit, time interval between arrival from operating room until leaving postanesthesia unit, between the two groups using Aldrete scale, score of 9 or greater allows patient to leave postanesthesia unit |
| Cost effect | 24 hours | Comparison of hospitalization fees among the two groups |
Countries
Greece
Outcome results
None listed