Opioid Versus Non-opioid Anesthesia for Ambulatory Surgery in Children

Athens General Children's Hospital "Pan. & Aglaia Kyriakou"

Status and phase: Completed; Phase 2

Conditions: Effect of Anesthesia in Extubation Time; Effect of Anesthesia in Postoperative Adverse Events; Effect of Anesthesia in Postoperative Pain; Effect of Anesthesia in Discharge Time From Postanesthesia Care Unit; Effect of Anesthesia in Discharge Time From the Hospital

Treatments: Drug: fentanyl, remifentanil; Drug: Ketamine, dexmedetomidine

Study type: Interventional

Funder types: Other

Identifiers

NCT03979469

Opioid free anesthesia 7.2018

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Ages: 3 to 16 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 2 patient groups

opiod free general anesthesia

Experimental group

Description:

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.

Treatment:

Drug: Ketamine, dexmedetomidine

opioid based general anesthesia

Active Comparator group

Description:

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.

Treatment:

Drug: fentanyl, remifentanil