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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 : March 2, 2022
Sponsor:
Information provided by (Responsible Party):
ebru biricik, Cukurova University

Study Description
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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. Morphine 0.1mg/kg IV will be apply for postoperative analgesia at 10 min of anesthesia. Extubation time, length of stay in PACU, PAED score, FLACC score will record. Than all data will statistically analyse.

Condition or disease Intervention/treatment Phase
Postoperative Recovery Drug: Ketamine Phase 4

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. Morphine 0.1mg/kg IV will be apply for postoperative analgesia at 10 min of anesthesia. Extubation time, length of stay in PACU, PAED score, FLACC score will record. Than all data will statistically analyse.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomised, controlled
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Effect of Ketamin+Propofol Mixture on Postoperative Recovery
Actual Study Start Date : February 15, 2021
Estimated Primary Completion Date : December 20, 2022
Estimated Study Completion Date : December 20, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Ketofol1/1
Propofol 1 mg/kg + ketamin1 mg/kg (1/1 ratio) for group I to anesthesia induction.
 Drug: Ketamine
Different mixture of ketamin-propofol will apply for anesthesia induction.
Other Name: ketofol
Active Comparator: Ketofol1/2
propofol 1,5 mg/kg + ketamin 0,75 mg/kg (2/1 ratio) for group II to anesthesia induction
 Drug: Ketamine
Different mixture of ketamin-propofol will apply for anesthesia induction.
Other Name: ketofol
Active Comparator: Ketofol1/3
propofol 2 mg/kg +ketamin 0,66 mg/kg (3/1 ratio) for group III to anesthesia induction
 Drug: Ketamine
Different mixture of ketamin-propofol will apply for anesthesia induction.
Other Name: ketofol
Active Comparator: propofol
propofol 3 mg/kg will perform for anesthesia induction
 Drug: Ketamine
Different mixture of ketamin-propofol will apply for anesthesia induction.
Other Name: ketofol


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Anxiety score [ Time Frame: 30 minutes in PACU ]
    PAED scores will record till the patient discharge from the PACU.


Eligibility Criteria
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Ages Eligible for Study:   3 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04761159


Locations
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Turkey
Cukurova University Recruiting
Adana, Turkey, 01380
Contact: Ebru Biricik, MD    05052420223    ebrubiricik01@gmail.com   
Sponsors and Collaborators
Cukurova University
More Information
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Responsible Party: ebru biricik, associate professor, Cukurova University
ClinicalTrials.gov Identifier: NCT04761159    
Other Study ID Numbers: Ketamin-propofol
First Posted: February 18, 2021    Key Record Dates
Last Update Posted: March 2, 2022
Last Verified: January 2022

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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
Additional relevant MeSH terms:
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Ketamine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
 Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action