NCT05474937

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
74

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 6, 2022

Completed
20 days until next milestone

First Posted

Study publicly available on registry

July 26, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
Last Updated

July 26, 2022

Status Verified

July 1, 2022

Enrollment Period

6 months

First QC Date

July 6, 2022

Last Update Submit

July 24, 2022

Conditions

Upper GI Bleeding

Outcome Measures

Primary Outcomes (1)

  • sedative effect

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

    1 hour

Secondary Outcomes (1)

  • adverse events

    2 hours

Study Arms (2)

inhalational Sevoflurane

ACTIVE COMPARATOR

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.

Drug: Sevoflurane Inhalation SolutionDrug: Midazolam, Ketamine and Propofol

Intravenous Ketamine, Midazolam and Propofol group

ACTIVE COMPARATOR

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.

Drug: Sevoflurane Inhalation SolutionDrug: Midazolam, Ketamine and Propofol

Interventions

Sevoflurane Inhalation SolutionDRUG

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).

Intravenous Ketamine, Midazolam and Propofol groupinhalational Sevoflurane
Midazolam, Ketamine and PropofolDRUG

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

Intravenous Ketamine, Midazolam and Propofol groupinhalational Sevoflurane

Eligibility Criteria

Age1 Year - 4 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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).

You may not qualify if:

  • Hypersensitivity to drugs included in the study.
  • Difficult airway or known airway problems.
  • Active bleeding from esophageal varices.
  • Respiratory and cardiac problems.
  • Neurological disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zagazig University Hospitals

Zagazig, Sharqia Province, 44111, Egypt

RECRUITING

Related Publications (6)

  • 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.

    PMID: 21704990BACKGROUND

  • 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.

    PMID: 14747816BACKGROUND

  • 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.

    PMID: 28579345BACKGROUND

  • 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.

    PMID: 34356589BACKGROUND

  • 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.

    PMID: 33810063BACKGROUND

  • 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.

    PMID: 31261820BACKGROUND

MeSH Terms

Conditions

Gastrointestinal Hemorrhage

Interventions

MidazolamKetaminePropofol

Condition Hierarchy (Ancestors)

Gastrointestinal DiseasesDigestive System DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPhenolsBenzene DerivativesHydrocarbons, Aromatic

Central Study Contacts

Salih Salim Salih, MBCCH

CONTACT

01142905781salihbahri86@gmail.com

Nahla M Amin, MD

CONTACT

01151980960

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: prospective randomized clinical trial
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident of anesthesia and intensive care

Study Record Dates

First Submitted

July 6, 2022

First Posted

July 26, 2022

Study Start

June 1, 2022

Primary Completion

November 30, 2022

Study Completion

December 30, 2022

Last Updated

July 26, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will share

all collected IPD, all IPD that underlie results in a publication

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
6 months after publication
Access Criteria
contact the principle investigator

Locations

EG(1)