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Remifentanil Use in Pediatric Rigid Bronchoscopy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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.


Condition or disease Intervention/treatment Phase
Pediatric Rigid Bronchoscopy Drug: Propofol Drug: Ketamine Drug: Remifentanil Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Remifentanil-based Total Intravenous Anesthesia for Pediatric Rigid Bronchoscopy: Comparison of Propofol and Ketamine As Adjuvant
Study Start Date : November 2005
Actual Primary Completion Date : August 2006
Actual Study Completion Date : August 2006

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Arm Intervention/treatment
Active Comparator: Group Propofol Drug: Propofol
Drug: Remifentanil
Active Comparator: Group Ketamine Drug: Ketamine
Drug: Remifentanil



Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   1 Month to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01947114


Locations
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Turkey
Bezmialem Vakif University Faculty of Medicine
Istanbul, Turkey, 34093
Sponsors and Collaborators
Bezmialem Vakif University
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Responsible Party: Mefkur Bakan, MD, Assistant Professor, Bezmialem Vakif University
ClinicalTrials.gov Identifier: NCT01947114    
Other Study ID Numbers: CTF.08.11.05/31128
First Posted: September 20, 2013    Key Record Dates
Last Update Posted: September 20, 2013
Last Verified: September 2013
Keywords provided by Mefkur Bakan, MD, Bezmialem Vakif University:
General anesthesia,
Children,
Rigid Bronchoscopy,
Remifentanil,
Propofol,
Ketamine.
Additional relevant MeSH terms:
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Muscle Rigidity
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Ketamine
Remifentanil
Propofol
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Dissociative
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Narcotics