The amount of anesthetic used during colonoscopy will be recorded as milligram/kilogram for each patient.
Propofol-Ketamine vs Remifentanyl-Ketamine for Sedation in Pediatric Patients Undergoing Colonoscopy
Brief Summary
Intervention / Treatment
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remifentanyl (DRUG)0,25 µg/kg remifentanyl will be administered for induction in 1 minute. Then 0,1 µg/kg/h remifentanyl infusion will be started.
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Propofol (DRUG)1 mg/kg propofol will be administered for induction and then 1 mg/kg/h propofol infusion will be started.
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Ketamine (DRUG)2 mg/kg ketamine will be administered for induction in 1 minute.
Condition or Disease
- Delayed Emergence From Anesthesia
Phase
Study Design
Study type: | INTERVENTIONAL |
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Status: | Completed |
Study results: | No Results Available |
Age: | 2 Years to 16 Years |
Enrollment: | 70 (ACTUAL) |
Funded by: | Other |
Allocation: | Randomized |
Primary Purpose: | Treatment |
MaskingSINGLE:
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Clinical Trial Dates
Start date: | Aug 01, 2016 | ACTUAL |
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Primary Completion: | Jan 01, 2017 | ACTUAL |
Completion Date: | Jan 01, 2017 | ACTUAL |
Study First Posted: | Nov 11, 2015 | ESTIMATED |
Results First Posted: | Aug 31, 2020 | |
Last Updated: | Feb 03, 2017 |
Sponsors / Collaborators
Location
Group I (RK); 2 mg/kg ketamine and 0,25 µg/kg remifentanyl will be administered for induction in 1 minute. Then 0,1 µg/kg/h remifentanyl infusion will be started.
Group II (PK); 2 mg/kg ketamine and 1 mg/kg propofol will be administered for induction and then 1 mg/kg/h propofol infusion will be started.
In case of movement, crying, heart rate and systolic blood pressure more than 20% increase from baseline; 0.05 to 0.1 mg / kg of remifentanil will be administered in group I, 0.5-1 mg / kg will be administered propofol in group II. Not enough that case 0.5-1 mg / kg of ketamine will be applied.
The anesthesiologist will continue monitoring after completion of colonoscopy until recovery of full consciousness. A Steward recovery score of 7 will be defined as the end of the recovery time. Throughout the process and during the postoperative observation, if systolic blood pressure more than 20% decrease from baseline will be applied 0,1 mg/kg ephedrine, if heart rate more than 20% decrease from baseline 0,01 mg/kg atropine will be applied.Colonoscopy time will be recorded. At the end of the procedure, the gastroenterologist will be asked to give a score in terms of ease attempt. (1=poor, 2=moderate, 3=good, 4=excellent) Adverse events will be recorded, including hypotension (decrease in blood pressure by 20% from baseline), hypertension (increase in blood pressure by 20% from baseline), bradycardia (decrease in heart rate by 20% from baseline), and hypoxia (oxygen desaturation with peripheral oxygen saturation \<90%). In addition, the need for additional medication and operator satisfaction among will be compared to the among groups.
Participant Groups
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Experimental:Remifentanyl and ketamine Remifentanyl vial 2 mg, Ketamine vial 500mg/10 mlt by intravenous. 2 mg/kg ketamine and 0,25 µg/kg remifentanyl will be administered for induction in 1 minute. Then 0,1 µg/kg/h remifentanyl infusion will be started.
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Active comparator:Propofol and ketamine Propofol injectable emulsion vial 200 mg/20 mlt, Ketamine vial 500mg/10 mlt by intravenous. 2 mg/kg ketamine and 1 mg/kg propofol will be administered for induction and then 1 mg/kg/h propofol infusion will be started.
Eligibility Criteria
Sex: | All |
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Minimum Age: | 2 |
Maximum Age: | 16 |
Age Groups: | Child |
Healthy Volunteers: | Yes |
* ASA I-II
* 2-16 years old children
Exclusion Criteria:
* Children with cardiovascular disease,
* Children with cerebral disorder, respiratory disease,
* Children with renal failure
* Children with hepatic failure
Primary Outcomes
Secondary Outcomes
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Blood pressure will be followed during colonoscopy and until modified aldrete score will be 9 points.
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Hypoxia (oxygen desaturation with peripheral oxygen saturation \<90%) will be followed during colonoscopy and until modified aldrete score will be 9 points.
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Heart rate will be followed during colonoscopy and until modified aldrete score will be 9 points.
More Details
NCT Number: | NCT02602743 |
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Other IDs: | PRK01 |
Study URL: | https://clinicaltrials.gov/study/NCT02602743 |