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

NCT ID: NCT05474937

Last Updated: 2022-07-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-01
• Study Completion Date: 2022-12-30

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.

Conditions

Upper GI Bleeding

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

inhalational Sevoflurane

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.

Group Type: ACTIVE_COMPARATOR

Sevoflurane Inhalation Solution

Intervention Type: DRUG

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

Intervention Type: DRUG

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 group

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.

Group Type: ACTIVE_COMPARATOR

Sevoflurane Inhalation Solution

Intervention Type: DRUG

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

Intervention Type: DRUG

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

Interventions

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).

Intervention Type: DRUG

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 4 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zagazig University

OTHER_GOV

Sponsor Role: lead

Responsible Party

Salih Salim Salih Bahri

Resident of anesthesia and intensive care

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Zagazig University Hospitals

Zagazig, Sharqia Province, Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Salih Salim Salih, MBCCH

Role: CONTACT

salihbahri86@gmail.com

01142905781 ext. 002

Nahla M Amin, MD

Role: CONTACT

01151980960 ext. 002

Facility Contacts

Salih Salim Salih, MBCCH

Role: primary

salihbahri86@gmail.com

01142905781 ext. 002

Nahla M Amin, MD

Role: backup

01151980960 ext. 002

References

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.

Reference Type: BACKGROUND

PMID: 21704990 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 14747816 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28579345 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 34356589 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 33810063 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31261820 (View on PubMed)

Other Identifiers

9535

Identifier Type: -

Identifier Source: org_study_id