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The comparison assessment the sedative effect of ketamine and propofol with oral midazolam in pediatric upper gastrointestinal endoscopy

The comparison assessment the sedative effect of ketamine and propofol with oral midazolam in pediatric upper gastrointestinal endoscopy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT2016121831457N1
Enrollment
94
Registered
2017-02-15
Start date
2016-11-10
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Condition 1: sedation effect of drug regimen in gasterointetinal endoscopy. Condition 2: sedation effect of drug regimen in gasterointetinal endoscopy. Condition 3: sedation effect of drug regimen in gasterointetinal endoscopy. Condition 4: sedation effect of drug regimen in gasterointetinal endoscopy. Condition 5: sedation effect of drug regimen in gasterointetinal endoscopy. Abdominal and pelvic pain Nausea and vomiting Heartburn Dysphagia Other symptoms and signs involving the digestive

Interventions

Intervention 1: In MP group oral midazolam half-mg dose and a maximum of 20 milligrams per kilogram of body weight. Intervention 2: Patients in the MP group injected with Propofol (Dayateb co.IRof Ira
Treatment - Other
In MP group oral midazolam half-mg dose and a maximum of 20 milligrams per kilogram of body weight
Patients in the MP group injected with Propofol (Dayateb co.IRof Iran Manufactured by Claris) bolus dose2 mg / kg (children younger than 3 years) and 1 mg / kg (in children older than 3 years) are to
MK Group IV sedation with ketamine in slow (Trittan / Germany) bolus1-2 mg / kg starts and after about 15-10 minutes the effect of ketamine sedation was reduced by as much as 0/5-1 mg / kg in during
In MK group oral midazolam half-mg dose and a maximum of 20 milligrams per kilogram of body weight

Sponsors

Babol University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Years to 14 Years

Inclusion criteria

Inclusion criteria: Inclusion Criteria:1-14 years old childs with gasterointestinal disease ; children with grade I, II classification (American Society of Anesthesia) ASA Exclusion Criteria: chronic diseases such as cardio-pulmonary disease, diabetes, infectious diseases and oncology ; chronic use of drugs affecting the respiratory system and cardiovascular, CNS

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Check the heart rate after administration of oral midazolam and ketamine and propofol sedative drugs. Timepoint: 1)Two minutes after administration of oral midazolam 2) When entering the endoscope 3) five minutes after endoscopic. Method of measurement: vital sign monitoring machine(saadat,BS-SN SNTI/e2/m/c).;Check the Respiratory Rate after administration of oral midazolam and ketamine and propofol sedative drugs. Timepoint: 1)Two minutes after administration of oral midazolam 2) When entering the endoscope 3) five minutes after endoscopic. Method of measurement: vital sign monitoring machine(saadat,BS-SN SNTI/e2/m/c).;The possible need to add a dose of medication ine MP groups as inadequate sedation with commonly defined doses. Timepoint: during endoscopy if inadequate sedation. Method of measurement: The milligrams of the drug.;The sedative affect in both groups before and during endoscopy start. Timepoint: Begins immediately before and five minutes after the start of endoscopy. Method of measurement: Rasey score clasification( 5=RSS ).;Check the Mean Arterial Pressure after administration of oral midazolam and ketamine and propofol sedative drugs. Timepoint: 1)Two minutes after administration of oral midazolam 2) When entering the endoscope 3) five minutes after endoscopic. Method of measurement: vital sign monitoring machine(saadat,BS-SN SNTI/e2/m/c).;Check the arterial O2 saturation after administration of oral midazolam and ketamine and propofol sedative drugs. Timepoint: 1)Two minutes after administration of oral midazolam 2) When entering the endoscope 3) five minutes after endoscopic. Method of measurement: vital sign monitoring machine(saadat,BS-SN SNTI/e2/m/c).;The possible need to add a dose of medication ine MK groups as inadequate sedation with commonly defined doses. Timepoint: during endoscopy if inadequate sedation. Method of measurement: The milligrams of the drug.

Secondary

MeasureTime frame
Compare vital signs after endoscopy. Timepoint: Fifteen minutes after the completion of endoscopy. Method of measurement: vital sign monitorin mashine(saadat).;The endoscopist satisfaction of sedation effect of each drug regimen. Timepoint: After the endoscopy. Method of measurement: Skills and experience of the endoscopist.;Compare potential drug side effects in both groups. Timepoint: After drug administration, during endoscopy,finish endoscop?. Method of measurement: Phisical exam and History.;Compare of recavery score. Timepoint: Fifteen minutes after the completion of endoscopy. Method of measurement: steward score system.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr Mahdi Farhadi

Amirkola Childeren's Hospital

M.farhadi@mubabol.ac.ir ,+98 11 3234 2151

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026