Clinical Trial: Remifentanil Use in Pediatric Rigid Bronchoscopy

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Remifentanil-based Total Intravenous Anesthesia for Pediatric Rigid Bronchoscopy: Comparison of Propofol and Ketamine As Adjuvant

Brief Summary:

Purpose: In this study we wanted to compare bolus propofol and ketamine as an adjuvant to remifentanil-based total intravenous anesthesia for pediatric rigid bronchoscopy.

Materials and Methods: Forty children under 12 years of age scheduled for rigid bronchoscopy were included. After midazolam premedication, remifentanil infusion 1 µg/kg/min was started and patients were randomly allocated to receive either propofol (Group P) or ketamine (Group K) and mivacurium for muscle relaxation. Anesthesia was maintained with remifentanil infusion 1 µg/kg/min and bolus doses of propofol or ketamine. After rigid bronchoscopy remifentanil 0.05 µg/kg/min was maintained until extubation. Hemodynamic parameters, emergence characteristics and adverse events were evaluated.

Detailed Summary:

After approval by Institutional Ethics Committee and obtaining informed consent of parents, 40 consecutive children under 12 years who were scheduled to have RB for diagnostic (suspected foreign body aspiration, bronchoalveolar lavage) and/or therapeutic purposes (removal of foreign bodies and/or mucus plugs) were included.

Fasting time before induction of anesthesia was at least 6 hours for solid food and 4 hours for clear liquids. Before admission to the preoperative holding area, a local anesthetic cream was applied to the insertion site and IV catheterization was performed. Midazolam (0.05 mg/kg) was given intravenously just before admission to the operating room. Pulse oximetry (SpO2), ECG and non-invasive blood pressure were monitored. Before induction all children were pre-oxygenated and a crystalloid infusion 10 mg/kg/h was started. Children were randomly allocated to one of two groups according to sealed envelopes. After a second dose of IV midazolam 0.05 mg/kg, remifentanil infusion 1 µg/kg/min was started. During the 1st minute of remifentanil infusion, propofol 2-4 mg/kg, including lidocaine 1 mg/mL for injection pain (Group P) or ketamine 2-3 mg/kg (Group K) was administered. When adequate mask ventilation was ensured, mivacurium 0.15 mg/kg was administered for muscle relaxation and RB was begun at the 4-5th minute of remifentanil infusion. Depth of anesthesia was assessed clinically by hemodynamic parameters (heart rate, blood pressure), movement, coughing, bucking, lacrimation and sweating. Additional doses of propofol (0.5-1 mg/kg) or ketamine (0.25-0.5 mg/kg), with or without mivacurium (0.025-0.05 mg/kg, according to the course of bronchoscopy) were given when inadequate depth of anesthesia was considered. Remifentanil infusion 1 µg/kg/min was maintained throughout the procedure.

Patients were m
Sponsor: Bezmialem Vakif University

Current Primary Outcome: Change in systolic arterial pressure [ Time Frame: Systolic arterial pressure was assessed before anesthesia induction (baseline), 2 minutes after anesthesia induction, at 1., 3., 6., 9., 12., and 15. minutes of rigid bronchoscopy. ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Bezmialem Vakif University

Dates:
Date Received: September 4, 2013
Date Started: November 2005
Date Completion:
Last Updated: September 17, 2013
Last Verified: September 2013