Upper GI BleedingNCT05474937
Inhalation of Sevoflurane Versus Intravenous Midazolam,Ketamine,Propofol For Pediatrics Undergoing Upper GI Endoscopy
A study testing Sevoflurane Inhalation Solution and Midazolam, Ketamine and Propofol in people with Upper GI Bleeding, run by Zagazig University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 4 years
- Conditions the study is for
- Upper GI Bleeding
- What is being tested?
- Sevoflurane Inhalation Solution and Midazolam, Ketamine and Propofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2022to 30 Dec 2022
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 4 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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).
Who cannot join
- Hypersensitivity to drugs included in the study.
- Difficult airway or known airway problems.
- Active bleeding from esophageal varices.
- Respiratory and cardiac problems.
- Neurological disorders
Trial locations and contacts
1 site in 1 country.
Nahla M Amin, MD contact
Egypt1 site, 1 recruiting
- Recruiting
Zagazig University Hospitals
Zagazig, Sharqia Province, 44111
Salih Salim Salih, MBCCH, 01142905781 ext. 002, salihbahri86@gmail.com
Nahla M Amin, MD, 01151980960 ext. 002
About this study
Official title: Nasal Inhalation of Sevoflurane Versus Midazolm,Ketamine and Propofol For Pediatric Undergoing Upper Gastrointestinal Endoscopy
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.
- Conditions
- Upper GI Bleeding
- Being tested
- Sevoflurane Inhalation Solution, Midazolam, Ketamine and Propofol
- Medical subject headings
- Gastrointestinal Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Sevoflurane Inhalation Solution; Drug: 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. Receives: Drug: Sevoflurane Inhalation Solution; Drug: Midazolam, Ketamine and Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
sedative effect
Sedative effect will be assessed in terms of induction time success of induction and maintenance
Measured: 1 hour
Secondary outcomes (1)
adverse events
Safety will be assessed in terms of occurrence of complications
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2022
- Study start1 Jun 2022
- Primary completion30 Nov 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Upper GI BleedingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- prospective randomized clinical trial
- Masking
- None (open label)
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Salih Salim Salih Bahri, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05474937
- Sponsor's protocol ID
- 9535
- Status last verified
- Jul 2022
- First submitted
- 6 Jul 2022
- Last updated
- 26 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all collected IPD, all IPD that underlie results in a publication
Publications
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.
PubMed 21704990Agrawal 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.
PubMed 14747816Basturk 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.
PubMed 28579345Biliskov 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.
PubMed 34356589Gaya 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.
PubMed 33810063Oh 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.
PubMed 31261820