Clinical trial NCT05474937: Inhalation of Sevoflurane Versus Intravenous Midazolam,Ketamine,Propofol For Pediatrics Undergoing Upper GI Endoscopy
Official title: Nasal Inhalation of Sevoflurane Versus Midazolm,Ketamine and Propofol For Pediatric Undergoing Upper Gastrointestinal Endoscopy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Upper GI Bleeding
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2022-07-26
Enrollment: 74
Sex: ALL
Minimum age (years): 1
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: prospective randomized clinical trial
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: sedative effect
timeFrame: 1 hour
Secondary outcomes:
measure: adverse events
timeFrame: 2 hours
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Zagazig University Hospitals
state: Sharkia
Study officials:
References:
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citation: Agrawal D, Feldman HA, Krauss B, Waltzman ML. Bispectral index monitoring quantifies depth of sedation during emergency department procedural sedation and analgesia in children. Ann Emerg Med. 2004 Feb;43(2):247-55. doi: 10.1016/s0196-0644(03)00721-2.
citation: Basturk A, Artan R, Yilmaz A. Efficacy and safety of midazolam and ketamine in paediatric upper endoscopy. Arab J Gastroenterol. 2017 Jun;18(2):80-82. doi: 10.1016/j.ajg.2017.05.004. Epub 2017 Jun 1.
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