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The effect of adding Ketamine to Dxmedetomidine and Propofol on the sedative quality and hemodynamic response in Children during Upper Gastrointestinal Endoscopy

Comparison of the effect of adding low doses of Ketamine to Dxmedetomidine and Propofol on the sedative quality and hemodynamic response in Children during Upper Gastrointestinal Endoscopy

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20180416039326N21
Enrollment
52
Registered
2022-06-01
Start date
2022-05-22
Completion date
Unknown
Last updated
2022-06-27

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

Conditions

Anesthesia for endoscopy.

Interventions

Intervention 1: Intervention group: In dexmedetomidine group (Dk), patients will receive 1-0. 7 micrograms per kilogram of dexmedetomidine and then bolus ketamine 0.4 mg per kilogram in 50 ml of norm

Sponsors

Esfahan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
2 Years to 12 Years

Inclusion criteria

Inclusion criteria: Consent of the patient or parents to participate in the study Patients aged 2 to 12 years

Exclusion criteria

Exclusion criteria: ventricular atrial block (Grade 2 or 3 ) in electrocardiography Slow heart rate QTc more than 550 Millisecondon electrocardiography Severe heart failure low blood pressure (systolic blood pressure less than 90 mmHg or diastolic blood pressure less than 60 mmHg) Liver disease Use of any analgesic drug (due to possible drug interactions with the two drugs used in the study and the possibility of influencing the conclusion and prejudice of anesthesia) History of any allergy to the drug used in the design (dexmedetomidine and propofol)

Design outcomes

Primary

MeasureTime frame
Sedation depth. Timepoint: Every 5 minutes during procedure and every 10 minutes in recovery. Method of measurement: Ramsey Sedation criteria.

Secondary

MeasureTime frame
Blood pressure. Timepoint: Before intervention, every 5 minutes after the intervention and every 10 minutes after the end of the intervention for 30 minutes. Method of measurement: Blood pressure barometer.;Heart rate. Timepoint: Before intervention, every 5 minutes after the intervention and every 10 minutes after the end of the intervention for 30 minutes. Method of measurement: Pulse oximeter.;Recovery time. Timepoint: After completing the intervention until the withdrawal from the recovery. Method of measurement: Minute Numbers.;Surgery time. Timepoint: From the beginning of the surgery. Method of measurement: Minute Numbers.;Duration of anesthesia. Timepoint: From the time of anesthesia injection to the time of consciousness. Method of measurement: Minute Numbers.;Complications (bradycardia, apnea). Timepoint: Before intervention, every 5 minutes after the intervention and every 10 minutes after the end of the intervention for 30 minutes. Method of measurement: Monitoring.;Incidence of complications in recovery. Timepoint: Every 10 minutes after the end of the intervention for 30 minutes. Method of measurement: Patient monitoring and observation.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactHamidreza Shetabi

Esfahan University of Medical Sciences

hamidshetabi@med.mui.ac.ir+98 31 3620 2020

Outcome results

None listed

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