Opioid Versus Non-opioid Anesthesia for Ambulatory Surgery in Children

Phase 2

Completed

• Conditions: Effect of Anesthesia in Postoperative Pain; Effect of Anesthesia in Extubation Time; Effect of Anesthesia in Discharge Time From Postanesthesia Care Unit; Effect of Anesthesia in Postoperative Adverse Events; Effect of Anesthesia in Discharge Time From the Hospital
• Interventions: Drug: fentanyl, remifentanil; Drug: Ketamine, dexmedetomidine

• Registration Number: NCT03979469
• Lead Sponsor: Athens General Children's Hospital "Pan. & Aglaia Kyriakou"

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-08-01
• Study First Submitted: 2019-05-09
• Study First Submitted QC: 2019-06-06
• Study First Posted: 2019-06-07
• Primary Completion: 2019-08-01
• Study Completion: 2019-08-01
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-11
• Last Update Posted: 2020-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
opioid based general anesthesia	fentanyl, remifentanil	In group B opioid based anesthesia is administered.Anesthesia and analgesia were achieved with remifentanil(0.3mcg/kg/minute), local anesthetic(ropivacaine 2mg/kg 0.75% wound infiltration), paracetamol(15mg/kg), non steroid analgesics(diclofenac 1mg/kg).Anesthesia induction with propofol 1% 2-3mg/kg,fentanyl(2mcg/kg), rocuronium 1mg/kg. Anesthesia maintenance with propofol 1% 10mg/kg/hour. Reversal of rocuronium with sugammadex 2mg/kg.
opiod free general anesthesia	Ketamine, dexmedetomidine	In group A opioid free anesthesia is administered. Anesthesia and analgesia were achieved with ketamine(1mg/kg, bolus), dexmedetomidine(1mcg/kg, over 10 minutes), local anesthetic(ropivacaine 2mg/kg 0.75% wound infiltration), paracetamol(15mg/kg), non steroid analgesics(diclofenac 1mg/kg). Anesthesia induction with ketamine(1mg/kg), propofol 1% 2-3mg/kg, rocuronium 1mg/kg. Anesthesia maintenance with propofol 1% 10mg/kg/hour. Reversal of rocuronium with sugammadex 2mg/kg.

Primary Outcome Measures

Name	Time	Method
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 the Face, Legs, Activity, Cry, Consolability scale or FLACC scale for children between the ages of 3 years and 7 years. The scale has five criteria, which are each assigned a score of 0, 1 or 2.The scale is scored in a range of 0-10 with 0 representing no pain.

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Childrens Hospital P. and A. Kyriakou Anesthesiology Department; 🇬🇷 Athens, Greece