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Comparing the two drug combinations namely propofol-ketamine with propofol-fentanyl for sedating the child during the procedure of inserting endoscope in the food pipe and small intestine

Comparison of propofol-ketamine with propofol-fentanyl for sedation during esophagogastroduodenoscopy in children â?? a randomized double blinded study.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2013/03/003472
Enrollment
74
Registered
2013-03-12
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: null- Patients requiring esophagogastroduodenoscopy

Interventions

Intervention1: propofol,ketamine: Ketamine (0.5mg/kg) by intravenous route. Propofol(1mg/kg) by intravenous route will be given initially in aliquots of half dose(0.5 mg/kg)followed 15 seconds late

Sponsors

JIPMER
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: (1) Children 3 -12 years of age. (2) Patients requiring diagnostic/therapeutic EGD.

Exclusion criteria

Exclusion criteria: The children with the following features will be excluded from the study: (1) Allergy to the study drugs during earlier endoscopies/soya and egg allergy. (2) Documented difficulty to achieve sedation despite maximum admissible doses of these drugs during earlier sedation. (3) Hypertension /glaucoma. (4) Neuropsychiatric disorders/encephalopathy that impair assessment during recovery. (5) Difficult airway.

Design outcomes

Primary

MeasureTime frame
Primary outcome: To compare the proportion of people who require additional doses of propofol in the first minute after sedation induction between the propofol - ketamine group and propofol - fentanyl group.Timepoint: Outcome assessed at the end of the study period.

Secondary

MeasureTime frame
1. To compare the total additional doses of propofol needed in the first minute after sedation induction ,the total dose of propofol needed to achieve optimal sedation for performing esophagogastroduodenoscopy ,the frequency of the adverse effects occurring during period of sedation and recovery ,the need for reinsertion of the endoscope due to suboptimal sedation and the endoscopistâ??s satisfaction for the procedure when the two drug combinations are used. Timepoint: Outcome assessed at the end of the study period.

Countries

India

Contacts

Public ContactJ Barath

Jawaharlal Institute of Postgraduate Medical Education and Research

spectrumchandar@gmail.com9442587352

Outcome results

None listed

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