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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

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.

Condition or disease Intervention/treatment Phase
Failed Moderate Sedation During Procedure Drug: Ketamine and Midazolam Drug: Propofol and Fentanyl Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 238 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Official Title: A Comparison of the Sedation With Intermittent Bolus Midazolam-Ketamine Versus Intermittent Bolus Propofol-Fentanyl During Endoscopy in Children: Randomized Trial
Study Start Date : January 2015
Actual Primary Completion Date : July 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

Arm Intervention/treatment
Active Comparator: Ketamine and Midazolam
ketamine 1 mg/kg midazolam 0.1 mg/kg
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)

Experimental: Propofol and Fentanyl
propofol 1 mg/kg fentanyl 1 mcg/kg
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)




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. adverse events that are related to study drugs [ Time Frame: six months ]
    number of patients with adverse events that are related to study drugs

  2. procedure time [ Time Frame: six months ]
    procedure time is defined as the time between the insertion of endoscope and removal of endoscope

  3. 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



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Ages Eligible for Study:   4 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
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Responsible Party: Ulas Emre Akbulut, Medical Doctor, Kanuni Sultan Suleyman Training and Research Hospital
ClinicalTrials.gov Identifier: NCT02732132    
Other Study ID Numbers: 2015/18
First Posted: April 8, 2016    Key Record Dates
Last Update Posted: April 11, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Fentanyl
Midazolam
Ketamine
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
Adjuvants, Anesthesia
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents