Inhalation of Sevoflurane Versus Intravenous Midazolam,Ketamine,Propofol For Pediatrics Undergoing Upper GI Endoscopy

Zagazig University

Status: Enrolling

Conditions: Upper GI Bleeding

Treatments: Drug: Midazolam, Ketamine and Propofol; Drug: Sevoflurane Inhalation Solution

Study type: Interventional

Funder types: Other

Identifiers

NCT05474937

9535

Details and patient eligibility

About

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.

Enrollment: 74 estimated patients

Sex: All

Ages: 1 to 4 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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74 participants in 2 patient groups

inhalational Sevoflurane

Active Comparator group

Description:

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.

Treatment:

Drug: Sevoflurane Inhalation Solution

Drug: Midazolam, Ketamine and Propofol

Intravenous Ketamine, Midazolam and Propofol group

Active Comparator group

Description:

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.

Treatment:

Drug: Sevoflurane Inhalation Solution

Drug: Midazolam, Ketamine and Propofol