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
Not Applicable
Completed
- Conditions
- Health Condition 1: null- Patients requiring esophagogastroduodenoscopy
- Registration Number
- CTRI/2013/03/003472
- Lead Sponsor
- JIPMER
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 74
Inclusion Criteria
(1) Children 3 -12 years of age.
(2) Patients requiring diagnostic/therapeutic EGD.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary outcome: <br/ ><br> 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 Outcome Measures
Name Time Method 1. To compare the total additional doses of propofol needed in the first minute after sedation induction <br/ ><br>,the total dose of propofol needed to achieve optimal sedation for performing esophagogastroduodenoscopy <br/ ><br>,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. <br/ ><br>Timepoint: Outcome assessed at the end of the study period.