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Ketamin Plus Propofol for Anesthesia Induction

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ClinicalTrials.gov Identifier: NCT04761159
Recruitment Status : Recruiting
First Posted : February 18, 2021
Last Update Posted : August 17, 2021
Sponsor:
Information provided by (Responsible Party):
ebru biricik, Cukurova University

Tracking Information
First Submitted Date  ICMJE January 28, 2021
First Posted Date  ICMJE February 18, 2021
Last Update Posted Date August 17, 2021
Actual Study Start Date  ICMJE February 15, 2021
Estimated Primary Completion Date December 20, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 11, 2021)
length of stay in PACU [ Time Frame: 30 minutes in PACU ]
The participants will observe in PACU till the Aldrete score will achieve 15. This duration of time will record.
Original Primary Outcome Measures  ICMJE
 (submitted: February 17, 2021)
length of stay in PACU [ Time Frame: 30 min in PACU ]
The participants will observe in PACU till the Aldrete score will achieve 15. This duration of time will record.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 11, 2021)
Anxiety score [ Time Frame: 30 minutes in PACU ]
PAED scores will record till the patient discharge from the PACU.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 17, 2021)
Anxiety score [ Time Frame: 30 min in PACU ]
PAED scores will record till the patient discharge from the PACU.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ketamin Plus Propofol for Anesthesia Induction
Official Title  ICMJE Effect of Ketamin+Propofol Mixture on Postoperative Recovery
Brief Summary ASA I-II 160 pediatric patients will recruit who underwent adenoidectomy-tonsillectomy surgery. Propofol 1 mg/kg + ketamin1 mg/kg (1/1 ratio) for group I; propofol 1,5 mg/kg + ketamin 0,75 mg/kg (2/1 ratio) for group II; propofol 2 mg/kg +ketamin 0,66 mg/kg (3/1 ratio) for group III; propofol 3 mg/kg will perform for anesthesia induction. General anesthesia will maintenance with sevoflurane 1-2% and O2/N2O mixture. Postoperative analgesia will provide with tramadol 2mg/kg IV at last 30 min of surgery. Extubation time, length of stay in PACU, PAED score, FLACC score, VAS score will record. Than all data will statistically analyse.
Detailed Description ASA I-II 160 pediatric patients will recruit who underwent adenoidectomy-tonsillectomy surgery in this randomised controlled study. The participants will divide into the 4 groups with computered random generation. The Different combination of propofol+ketamin mixture will apply at the induction of anesthesia. The groups will assign as group I,II, III and IV. Propofol 1 mg/kg + ketamin1 mg/kg (1/1 ratio) for group I; propofol 1,5 mg/kg + ketamin 0,75 mg/kg (2/1 ratio) for group II; propofol 2 mg/kg +ketamin 0,66 mg/kg (3/1 ratio) for group III; propofol 3 mg/kg will perform for anesthesia induction. Fentanyl 1 microgram per kg and rocuronium 0.6 mg/kg will apply for anesthesia induction to the all participants. General anesthesia will maintenance with sevoflurane 1-2% and O2/N2O mixture. Postoperative analgesia will provide with tramadol 2mg/kg IV at last 30 min of surgery. Extubation time, length of stay in PACU, PAED score, FLACC score, VAS score will record. Than all data will statistically analyse.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Randomised, controlled
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Condition  ICMJE Postoperative Recovery
Intervention  ICMJE Drug: Ketamine
Different mixture of ketamin-propofol will apply for anesthesia induction.
Other Name: ketofol
Study Arms  ICMJE
  • Active Comparator: Ketofol1/1
    Propofol 1 mg/kg + ketamin1 mg/kg (1/1 ratio) for group I to anesthesia induction.
    Intervention: Drug: Ketamine
  • Active Comparator: Ketofol1/2
    propofol 1,5 mg/kg + ketamin 0,75 mg/kg (2/1 ratio) for group II to anesthesia induction
    Intervention: Drug: Ketamine
  • Active Comparator: Ketofol1/3
    propofol 2 mg/kg +ketamin 0,66 mg/kg (3/1 ratio) for group III to anesthesia induction
    Intervention: Drug: Ketamine
  • Active Comparator: propofol
    propofol 3 mg/kg will perform for anesthesia induction
    Intervention: 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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 17, 2021)
160
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 20, 2021
Estimated Primary Completion Date December 20, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • ASA I-II patients
  • Underwent adenoidectomy-tonsillectomy surgery
  • Age between 3-12

Exclusion Criteria:

  • ASA III-IV patients
  • Age; under 3 years old
  • Age; above 12 years old.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 3 Years to 12 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Listed Location Countries  ICMJE Turkey
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04761159
Other Study ID Numbers  ICMJE Ketamin-propofol
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party ebru biricik, Cukurova University
Study Sponsor  ICMJE Cukurova University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Cukurova University
Verification Date January 2021

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