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A Comparison of the Sedation During Endoscopy in Children

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ClinicalTrials.gov Identifier: NCT02732132
Recruitment Status : Completed
First Posted : April 8, 2016
Last Update Posted : April 11, 2016
Sponsor:
Information provided by (Responsible Party):
Ulas Emre Akbulut, Kanuni Sultan Suleyman Training and Research Hospital

Tracking Information
First Submitted Date  ICMJE March 23, 2016
First Posted Date  ICMJE April 8, 2016
Last Update Posted Date April 11, 2016
Study Start Date  ICMJE January 2015
Actual Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 8, 2016)
the effectiveness of sedation [ Time Frame: six months ]
the effectiviness of midazolam plus ketamine versus fentanyl plus propofol according to a modified Ramsay sedation score
Original Primary Outcome Measures  ICMJE
 (submitted: April 3, 2016)
the effectiviness of midazolam plus ketamine versus fentanyl plus propofol according to a modified Ramsay sedation score [ Time Frame: six months ]
238 patients (119 patients with midazolam-ketamine in group A, 119 patients propofol-fentanyl in group B) were compared in terms of effectiveness according to a modified Ramsay sedation score
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 8, 2016)
  • adverse events that are related to study drugs [ Time Frame: six months ]
    number of patients with adverse events that are related to study drugs
  • procedure time [ Time Frame: six months ]
    procedure time is defined as the time between the insertion of endoscope and removal of endoscope
  • recovery time [ Time Frame: six months ]
    recovery time is defined as the time from completing the endoscopy to achieving Aldrete score 10 in the recovery unit Aldrete score
Original Secondary Outcome Measures  ICMJE
 (submitted: April 3, 2016)
the complications of administered anesthetics were compared with CTCAE v4.0 [ Time Frame: six months ]
238 patients (119 patients with midazolam-ketamine in group A, 119 patients propofol-fentanyl in group B) were compared in terms of adverse events with CTCAE v4.0 according to already reported complications in the literature
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Comparison of the Sedation During Endoscopy in Children
Official Title  ICMJE A Comparison of the Sedation With Intermittent Bolus Midazolam-Ketamine Versus Intermittent Bolus Propofol-Fentanyl During Endoscopy in Children: Randomized Trial
Brief Summary The primary aim of this study was to investigate the efficiency and safety of midazolam plus ketamine versus fentanyl plus propofol administered to children undergoing UGE and to determine the most appropriate sedation protocol.
Detailed Description

The patients were given a spray of lidocaine 10% as a topical pharyngeal anaesthesia before sedation. Intravenous midazolam bolus dose 0.1 mg/kg (maximum 4 mg) was administered to Group A. Two minutes later, ketamine bolus dose 1 mg/kg was given intravenously. Patient responses to verbal and tactile stimuli were evaluated two minutes after ketamine application. Ketamine 0.5 mg/kg (maximum of 2 mg/kg) was added in two minute intervals if adequate sedation was not achieved initially. The endoscopy process was initiated by the endoscopist if there was no response. If the patients were agitated after the procedure started, a ketamine 0.5 mg/kg single dose was applied. Intravenous fentanyl bolus dose 1µg/kg was administered to Group B. Two minutes later, propofol bolus dose 1 mg/kg was given intravenously. Patient responses to verbal and tactile stimuli were evaluated two minutes after propofol application. Propofol 0.5 mg/kg was added in two minute intervals if adequate sedation was not achieved. The endoscopy process was initiated by the endoscopist if there was no response. If the patients were agitated after the procedure started, a propofol 0.5 mg/kg single dose was applied. None of the patients were given an antidote after the process during recovery.

All patients were monitored for peripheral oxygen saturation, heart rate (HR), respiratory rate, and RSS during the procedure. Oxygen (2L/min) by nasal cannula was given to all patients during the procedure. Hypoxia (peripheral oxygen saturation <90% during 60 seconds), apnea, laryngospasm, tachycardia (defined as 30% more than the average heart rate by age), bradycardia (30% less than the average heart rate by age), increase in oral secretions (more than enough to warrant aspiration), flushing, coughing and vomiting were assessed as complications and recorded.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Condition  ICMJE Failed Moderate Sedation During Procedure
Intervention  ICMJE
  • Drug: Ketamine and Midazolam
    This group was injected intravenous midazolam 0.1 mg/kg (maximum 4 mg), two minutes later, ketamine 1 mg/kg was given intravenously before the start of endoscopy.
    Other Name: Ketalar (Ketamin, Pfizer) and Dormicum (Midazolam, Roche)
  • Drug: Propofol and Fentanyl
    This group was injected intravenous fentanyl 1 mcg/kg, and two minutes later, propofol 1 mg/kg was given intravenously before the start of endoscopy.
    Other Name: Propofol Lipuro (Propofol, B-Braun) Fentanyl (Fentanyl, J&J)
Study Arms  ICMJE
  • Active Comparator: Ketamine and Midazolam
    ketamine 1 mg/kg midazolam 0.1 mg/kg
    Intervention: Drug: Ketamine and Midazolam
  • Experimental: Propofol and Fentanyl
    propofol 1 mg/kg fentanyl 1 mcg/kg
    Intervention: Drug: Propofol and Fentanyl
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: April 3, 2016)
238
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2015
Actual Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • All the patients were in ASA (American Society of Anesthesiologists) physical status I or II.

Exclusion Criteria:

  • Patients with respiratory tract infections, glaucoma, psychosis, porphyria, hypertension, metabolic or neurologic diseases, increased intracranial pressure and intracranial mass, and patients known to be allergic to the drugs used were excluded from the study.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 4 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02732132
Other Study ID Numbers  ICMJE 2015/18
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Ulas Emre Akbulut, Kanuni Sultan Suleyman Training and Research Hospital
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Kanuni Sultan Suleyman Training and Research Hospital
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Kanuni Sultan Suleyman Training and Research Hospital
Verification Date April 2016

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