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Propofol-Ketamine vs Remifentanyl-Ketamine for Sedation in Pediatric Patients Undergoing Colonoscopy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02602743
Recruitment Status : Completed
First Posted : November 11, 2015
Last Update Posted : February 6, 2017
Sponsor:
Information provided by (Responsible Party):
Feride Karacaer, Cukurova University

Tracking Information
First Submitted Date  ICMJE November 6, 2015
First Posted Date  ICMJE November 11, 2015
Last Update Posted Date February 6, 2017
Actual Study Start Date  ICMJE August 2016
Actual Primary Completion Date January 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 11, 2015)
Ketamine, remifentanyl, propofol consumption [ Time Frame: 1 hour ]
The amount of anesthetic used during colonoscopy will be recorded as milligram/kilogram for each patient.
Original Primary Outcome Measures  ICMJE
 (submitted: November 10, 2015)
drug consumption [ Time Frame: 1 hour ]
Drug consumption for sedation and analgesia will be followed during colonoscopy
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 10, 2015)
  • Blood pressure [ Time Frame: 1 hour ]
    Blood pressure will be followed during colonoscopy and until modified aldrete score will be 9 points.
  • Hypoxia [ Time Frame: 1 hour ]
    Hypoxia (oxygen desaturation with peripheral oxygen saturation <90%) will be followed during colonoscopy and until modified aldrete score will be 9 points.
  • Heart rate [ Time Frame: 1 hour ]
    Heart rate will be followed during colonoscopy and until modified aldrete score will be 9 points.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Propofol-Ketamine vs Remifentanyl-Ketamine for Sedation in Pediatric Patients Undergoing Colonoscopy
Official Title  ICMJE Propofol-Ketamine vs Remifentanyl-Ketamine for Sedation in Pediatric Patients Undergoing Colonoscopy
Brief Summary

Ketamine and propofol have been used most frequently agents and remifentanil is used with increasing frequency in recent years. Investigators will compare ketamine-propofol and ketamine-remifentanyl effects on drug consumption, respiration, hemodynamics and recovery in pediatric colonoscopy patients. Our study is a prospective, randomized comparison of ketamine-propofol and remifentanyl-propofol for sedation in pediatric patients during elective colonoscopy. ASA I-II, 2-16 years old, seventy children will be included in the study after ethics committee approval and written informed consent from the parents. Children with cardiovascular, cerebral, pulmonary, renal and hepatic diseases will be excluded from the study. 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.

Detailed Description

Optimal drug combinations for sedation and analgesia for the diagnosis and treatment of interventional procedures performed in pediatric patients still continue to be the main subject of many scientific studies. The drugs used for this purpose have advantages and disadvantages against each other. Ketamine and propofol have been used most frequently agents and remifentanil is used with increasing frequency in recent years. Investigators will compare ketamine-propofol and ketamine-remifentanyl effects on drug consumption, respiration, hemodynamics and recovery in pediatric colonoscopy patients. Our study is a prospective, randomized comparison of ketamine-propofol and remifentanyl-propofol for sedation and analgesia in pediatric patients during elective colonoscopy. ASA I-II, 2-16 years old, seventy children will included in the study after ethics committee approval and written informed consent from the parents. Children with cardiovascular, cerebral, pulmonary, renal and hepatic diseases will excluded from the study. Patients will be divided into two groups randomly. Patients will fast for at least 6 hours and have an i.v. line in place for the duration of sedation and recovery. All patients will be administered 0,5 mg/kg midazolam orally for premedication 30 minutes before the procedure. Heart rate, systolic and diastolic arterial pressure, peripheral oxygen saturation, respiratory rate and Ramsay sedation scores of all of patients will recorded at baseline, after induction and every 5 minutes during the procedure by the anesthesiologist. All of the patients will receive oxygen (2-4 L/min) through a nasal cannula and 10 ml/kg/h crystalloid infusion perioperatively. The level of recovery at the end of the procedure will be evaluated by Steward Recovery Score.

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Delayed Emergence From Anesthesia
Intervention  ICMJE
  • Drug: Remifentanyl
    0,25 µg/kg remifentanyl will be administered for induction in 1 minute. Then 0,1 µg/kg/h remifentanyl infusion will be started.
    Other Name: Ultiva
  • Drug: Propofol
    1 mg/kg propofol will be administered for induction and then 1 mg/kg/h propofol infusion will be started.
    Other Name: Pofol
  • Drug: Ketamine
    2 mg/kg ketamine will be administered for induction in 1 minute.
    Other Name: Ketalar
Study Arms  ICMJE
  • Experimental: remifentanyl, ketamine
    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.
    Interventions:
    • Drug: Remifentanyl
    • Drug: Ketamine
  • Active Comparator: propofol, ketamine

    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.

    Interventions:
    • Drug: Propofol
    • Drug: Ketamine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 3, 2017)
70
Original Estimated Enrollment  ICMJE
 (submitted: November 10, 2015)
60
Actual Study Completion Date  ICMJE January 2017
Actual Primary Completion Date January 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Years to 16 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Turkey
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02602743
Other Study ID Numbers  ICMJE PRK01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Feride Karacaer, Cukurova University
Study Sponsor  ICMJE Cukurova University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Dilek Özcengiz, Prof Çukurova University
Study Chair: Çağatay Küçükbingöz, Asistant dr Çukurova University
PRS Account Cukurova University
Verification Date February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP