Propofol-Ketamine vs Remifentanyl-Ketamine for Sedation in Pediatric Patients Undergoing Colonoscopy
Condition: Delayed Emergence From Anesthesia
MeSH terms: Delayed Emergence from Anesthesia
Study type: Interventional
Phase: Phase 4

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.
    

Intervention name(s): Remifentanyl; Propofol; Ketamine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 0,25 µg/kg remifentanyl will be administered for induction in 1 minute. Then 0,1 µg/kg/h remifentanyl infusion will be started.; 1 mg/kg propofol will be administered for induction and then 1 mg/kg/h propofol infusion will be started.; 2 mg/kg ketamine will be administered for induction in 1 minute.
Other intervention name(s): Ultiva; Pofol; Ketalar
Intervention MeSH terms: Ketamine; Remifentanil; Propofol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: sedation; remifentanyl; pediatric patient; colonoscopy