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

Upper GI Bleeding Clinical Trial

Official title:

Nasal Inhalation of Sevoflurane Versus Midazolm,Ketamine and Propofol For Pediatric Undergoing Upper Gastrointestinal Endoscopy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05474937
• Other study ID #: 9535
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2022
• Est. completion date: December 30, 2022

Study information

• Verified date: July 2022
• Source: Zagazig University
• Contact: Salih Salim Salih, MBCCH
• Phone: 01142905781
• Email: salihbahri86[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 74
• Est. completion date: December 30, 2022
• Est. primary completion date: November 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 4 Years

Eligibility

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

Related Conditions & MeSH terms

• Gastrointestinal Hemorrhage
• Upper GI Bleeding

Intervention

Drug:
• Sevoflurane Inhalation Solution
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 Propofol
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

Locations

Country	Name	City	State
Egypt	Zagazig University Hospitals	Zagazig	Sharkia

Sponsors (1)

Lead Sponsor	Collaborator
Zagazig University

Country where clinical trial is conducted

Egypt, 

References & 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. — View 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. — View 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. — View Citation

Biliškov 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). pii: 610. doi: 10.3390/children8070610. — View 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). pii: 1306. doi: 10.3390/jcm10061306. Review. — View 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). pii: E943. doi: 10.3390/jcm8070943. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	sedative effect	Sedative effect will be assessed in terms of induction time success of induction and maintenance	1 hour
Secondary	adverse events	Safety will be assessed in terms of occurrence of complications	2 hours