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Remifentanil Use in Pediatric Rigid Bronchoscopy

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ClinicalTrials.gov Identifier: NCT01947114
Recruitment Status : Completed
First Posted : September 20, 2013
Last Update Posted : September 20, 2013
Sponsor:
Information provided by (Responsible Party):
Mefkur Bakan, MD, Bezmialem Vakif University

Tracking Information
First Submitted Date  ICMJE September 4, 2013
First Posted Date  ICMJE September 20, 2013
Last Update Posted Date September 20, 2013
Study Start Date  ICMJE November 2005
Actual Primary Completion Date August 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 17, 2013)
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. ]
Noninvasive systolic blood pressure was measured with 3 minutes of interval during rigid bronchoscopy. The duration of rigid bronchoscopy was 10-15 minutes.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Remifentanil Use in Pediatric Rigid Bronchoscopy
Official Title  ICMJE 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 Description

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 manually ventilated with a 'T' piece connected to the side arm of the rigid bronchoscope. The fresh gas flow was adjusted to 6-10 L/min. In case of major air leakage, oxygen flush valve was used for adequate filling of the reservoir bag while airway pressure limit was adjusted to 20-30 cmH2O.

After bronchoscopy, endotracheal intubation was performed, manually controlled or assisted ventilation with 4-8 cmH2O PEEP and 50% oxygen in air was performed. Tracheal and oral secretions were suctioned as needed and the patients were turned to the lateral decubitus position for recovery. After being placed in the recovery position, no further stimulation was allowed except gentle suctioning of oral secretions and for a smooth extubation remifentanil infusion was decreased to 0.05 µg/kg/min and continued until just before extubation. When patients began to demonstrate emergence from anesthesia by displaying a regular respiratory pattern, facial grimacing or purposeful movement, trachea was extubated. In cases of breath-holding and arterial oxygen desaturation, assisted or controlled mask ventilation was performed. Pure oxygen was administered via the mask in order to maintain SpO2 above 94%.

Noninvasive blood pressure was measured before induction as a baseline value, after induction (just before laryngoscopy) and in 3 minutes of interval during rigid bronchoscopy. Hypotension was defined as a systolic blood pressure lower than 60 mmHg for children under 2 years and 70 mmHg for children 2-12 years old. Hypotension was treated with an increase in IV crystalloid infusion and two consecutive measures of hypotension treated with ephedrine and a decrease in remifentanil infusion. Bradycardia was defined as a heart rate slower than 80 beats/min for infants and 60 beats/min for older children (11) and treated with atropine 0.01 mg/kg.

SpO2 values below 90% were defined as hypoxemia. The severity of hypoxemia was graded as mild (SpO2: 80-89%), moderate (SpO2: 70-79%) or severe (SpO2<70%). Coughing or respiratory effort (diaphragm movement) and limb movement during laryngoscopy and rigid bronchoscopy was graded as mild (minor movement that does not effect surgical comfort), moderate (effect surgical comfort) or severe (the bronchoscope has to be removed or any complication) by the endoscopist. Postoperative severe restlessness and disorientation with purposeless activity were defined as emergence agitation. All adverse events were recorded by an independent observer.

A pilot study was performed with the technique used for the Group P. Power analysis showed that a minimum sample size of 40 patients (20 in each group) was required to detect a 20% change in arterial pressures at a power level of 90% with p<0.05. Categorical variables and hemodynamic parameters were analyzed using Mann-Whitney U Test and repeated-measures Anova respectively. Comparison of the incidence of the outcomes between the two groups was analyzed by a two-tailed Fisher's exact test. Statistical significance was defined as p<0.05.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Pediatric Rigid Bronchoscopy
Intervention  ICMJE
  • Drug: Propofol
  • Drug: Ketamine
  • Drug: Remifentanil
Study Arms  ICMJE
  • Active Comparator: Group Propofol
    Interventions:
    • Drug: Propofol
    • Drug: Remifentanil
  • Active Comparator: Group Ketamine
    Interventions:
    • Drug: Ketamine
    • Drug: Remifentanil
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 17, 2013)
40
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2006
Actual Primary Completion Date August 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Children who were scheduled to have rigid bronchoscopy for diagnostic purposes (suspected foreign body aspiration, bronchoalveolar lavage)
  • Children who were scheduled to have rigid bronchoscopy for therapeutic purposes (removal of foreign bodies and/or mucus plugs)

Exclusion Criteria:

  • Severe cardiovascular disease
  • Cerebral, hepatic or renal dysfunction
  • Neuromuscular disease
  • Children with predicted difficulty in laryngoscopy and intubation
  • Patients requiring prompt interventions for a life-threatening situation (acutely compromised airway with SpO2 values below 70%)
  • Patients scheduled for additional interventions or surgery subsequent to rigid bronchoscopy
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Month to 12 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Turkey
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01947114
Other Study ID Numbers  ICMJE CTF.08.11.05/31128
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Mefkur Bakan, MD, Bezmialem Vakif University
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Bezmialem Vakif University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Bezmialem Vakif University
Verification Date September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP