Upper GI Bleeding
Conditions
Brief summary
In the field of pediatric gastroenterology, upper gastrointestinal endoscopy has established itself as a diagnostic and therapeutic tool. In order to increase patient tolerance during this procedure, deep sedation is essential. Children are at a higher risk of serious adverse effects from procedural sedation; thus, their safety is a primary issue throughout this procedure. Multiple studies have been done to find the ideal method for procedural sedation in terms of ease of administration, quality, safety of sedation and recovery profile, but the consensus seems lacking. In this study we will compare between nasal inhalation of sevoflurane versus intravenous ketamine, midazolam and propofol for pediatrics undergoing upper gastrointestinal endoscopy.
Interventions
Patients in inhalational group will receive Sevoflurane at 7% dial concentration in 100% O2 by an appropriately sized face mask until adequate sedation occurs as adequate jaw relaxation for the endoscope insertion and attainment of Modified Ramsay Sedation Score (MRSS) 7 (i.e., Asleep, reflex withdrawal to painful stimuli only).
DRUGMidazolam, Ketamine and Propofol
Preoxygenation with 100% O2 for 1 minute, by proper sized face mask. Patients in Ketamine -midazolam -propofol (KMP) group will receive 1-1.5 mg/kg IV ketamine and 0.05mg/kg IV Midazolam and 1mg/kg IV Propofol as induction dose then followed by incremental doses of 0.5 mg/kg IV Propofol alone for maintenance and if procedure is prolonged propofol infusion at 100 μg/kg/min is given for maintenance of sedation. Induction dose will be considered as adequate if adequate jaw relaxation for endoscope insertion and Modified Ramsay Sedation Score (MRSS) ≥7 occurs with maintenance of spontaneous respiration. Induction time will be considered as time from beginning of IV agent to achievement of MRSS ≥7. After endoscope insertion, maintenance of oxygenation by nasal cannula at flow twice the minute ventilation of the patient
Sponsors
Zagazig University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
prospective randomized clinical trial
Eligibility
Sex/Gender
ALL
Age
1 Years to 4 Years
Healthy volunteers
No
Inclusion criteria
1. A consent from the parents or 1st degree relative. 2. Both sexes. 3. Pediatric patients aged 1year to 4 years old undergoing 4. elective upper GI endoscopy. 5. ASA class I &II. 6. BMI between 5th percentile and the 85th percentile (http://www.kidshealth.org).
Exclusion criteria
1. Hypersensitivity to drugs included in the study. 2. Difficult airway or known airway problems. 3. Active bleeding from esophageal varices. 4. Respiratory and cardiac problems. 5. Neurological disorders
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| sedative effect | 1 hour | Sedative effect will be assessed in terms of induction time success of induction and maintenance |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| adverse events | 2 hours | Safety will be assessed in terms of occurrence of complications |
Countries
Egypt
Contacts
Primary ContactSalih Salim Salih, MBCCH
Backup ContactNahla M Amin, MD
Outcome results
None listed