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

Primary Purpose

Upper GI Bleeding

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Sevoflurane Inhalation Solution
Midazolam, Ketamine and Propofol
Sponsored by
Zagazig University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Upper GI Bleeding

Eligibility Criteria

1 Year - 4 Years (Child)All SexesDoes not accept 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

Sites / Locations

  • Zagazig University HospitalsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

inhalational Sevoflurane

Intravenous Ketamine, Midazolam and Propofol group

Arm 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.

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.

Outcomes

Primary Outcome Measures

sedative effect
Sedative effect will be assessed in terms of induction time success of induction and maintenance

Secondary Outcome Measures

adverse events
Safety will be assessed in terms of occurrence of complications

Full Information

First Posted
July 6, 2022
Last Updated
July 24, 2022
Sponsor
Zagazig University
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1. Study Identification

Unique Protocol Identification Number
NCT05474937
Brief Title
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

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2022 (Actual)
Primary Completion Date
November 30, 2022 (Anticipated)
Study Completion Date
December 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zagazig University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Upper GI Bleeding

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
prospective randomized clinical trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
74 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
inhalational Sevoflurane
Arm Type
Active Comparator
Arm 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.
Arm Title
Intravenous Ketamine, Midazolam and Propofol group
Arm Type
Active Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Sevoflurane Inhalation Solution
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
Midazolam, Ketamine and Propofol
Intervention 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
Primary Outcome Measure Information:
Title
sedative effect
Description
Sedative effect will be assessed in terms of induction time success of induction and maintenance
Time Frame
1 hour
Secondary Outcome Measure Information:
Title
adverse events
Description
Safety will be assessed in terms of occurrence of complications
Time Frame
2 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
4 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: A consent from the parents or 1st degree relative. Both sexes. Pediatric patients aged 1year to 4 years old undergoing elective upper GI endoscopy. ASA class I &II. BMI between 5th percentile and the 85th percentile (http://www.kidshealth.org). Exclusion Criteria: Hypersensitivity to drugs included in the study. Difficult airway or known airway problems. Active bleeding from esophageal varices. Respiratory and cardiac problems. Neurological disorders
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Salih Salim Salih, MBCCH
Phone
01142905781
Ext
002
Email
salihbahri86@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Nahla M Amin, MD
Phone
01151980960
Ext
002
Facility Information:
Facility Name
Zagazig University Hospitals
City
Zagazig
State/Province
Sharkia
ZIP/Postal Code
44111
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Salih Salim Salih, MBCCH
Phone
01142905781
Ext
002
Email
salihbahri86@gmail.com
First Name & Middle Initial & Last Name & Degree
Nahla M Amin, MD
Phone
01151980960
Ext
002

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
all collected IPD, all IPD that underlie results in a publication
IPD Sharing Time Frame
6 months after publication
IPD Sharing Access Criteria
contact the principle investigator
Citations:
PubMed Identifier
21704990
Citation
Agostoni M, Fanti L, Gemma M, Pasculli N, Beretta L, Testoni PA. Adverse events during monitored anesthesia care for GI endoscopy: an 8-year experience. Gastrointest Endosc. 2011 Aug;74(2):266-75. doi: 10.1016/j.gie.2011.04.028. Epub 2011 Jun 25.
Results Reference
background
PubMed Identifier
14747816
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.
Results Reference
background
PubMed Identifier
28579345
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.
Results Reference
background
PubMed Identifier
34356589
Citation
Biliskov AN, Ivancev B, Pogorelic Z. Effects on Recovery of Pediatric Patients Undergoing Total Intravenous Anesthesia with Propofol versus Ketofol for Short-Lasting Laparoscopic Procedures. Children (Basel). 2021 Jul 19;8(7):610. doi: 10.3390/children8070610.
Results Reference
background
PubMed Identifier
33810063
Citation
Gaya da Costa M, Kalmar AF, Struys MMRF. Inhaled Anesthetics: Environmental Role, Occupational Risk, and Clinical Use. J Clin Med. 2021 Mar 22;10(6):1306. doi: 10.3390/jcm10061306.
Results Reference
background
PubMed Identifier
31261820
Citation
Oh C, Kim Y, Eom H, Youn S, Lee S, Ko YB, Yoo HJ, Chung W, Lim C, Hong B. Procedural Sedation Using a Propofol-Ketamine Combination (Ketofol) vs. Propofol Alone in the Loop Electrosurgical Excision Procedure (LEEP): A Randomized Controlled Trial. J Clin Med. 2019 Jun 28;8(7):943. doi: 10.3390/jcm8070943.
Results Reference
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Inhalation of Sevoflurane Versus Intravenous Midazolam,Ketamine,Propofol For Pediatrics Undergoing Upper GI Endoscopy

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