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Dexmedetomidine-Propofol and Ketamine-Propofol During Upper Gastrointestinal System Sedation

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ClinicalTrials.gov Identifier: NCT04399226
Recruitment Status : Completed
First Posted : May 22, 2020
Last Update Posted : May 22, 2020
Sponsor:
Information provided by (Responsible Party):
Arzu Esen Tekeli, Yuzuncu Yıl University

Tracking Information
First Submitted Date April 29, 2020
First Posted Date May 22, 2020
Last Update Posted Date May 22, 2020
Actual Study Start Date October 18, 2019
Actual Primary Completion Date February 20, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 18, 2020)
Demographic data [ Time Frame: 2 minutes ]
no difference
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: May 18, 2020)
adverse events [ Time Frame: 2 minutes ]
Nausea, vomiting and allergic reaction, cough
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: May 18, 2020)
sedation depth [ Time Frame: 2 minutes ]
Measured with BIS
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title Dexmedetomidine-Propofol and Ketamine-Propofol During Upper Gastrointestinal System Sedation
Official Title Efficacy and Safety of Deksmedetomidine-propofol or Ketamine-propofol
Brief Summary Sedation with dexmedetomidine-propofol or ketamine-propofol was planned in patients with upper gastrointestinal endoscopy.
Detailed Description Patients between 18 and 60 years in American Society of Anesthesiologists (ASA) I and II groups were included. Patients that had severe organ disease, allergies to study drugs, refused to participate in the study were excluded. Cases were randomized into the dexmedetomidine-propofol group (Group D, n=30) and ketamine-propofol group (Group K, n=30). Cardiac monitoring, peripheral oxygen saturation, bispectral index (BIS) monitoring were performed. Group D received 1mg/kg dexmedetomidine+0.5mg/kg propofol intravenous (iv) bolus, 0.5 μg/kg/h dexmedetomidine+ 0.5 mg/kg/h propfol infusion. Group K received 0.125 mL/kg bolus, 0.125 mL/kg/h ketamine+ propofol = ketofol infusion (ketofol was prepared with 4 mg propofol+2 mg ketamine). Patients were followed up with a Ramsay Sedation Scale (RSS) of≥4. Mean, standard deviation, mean, lowest-highest frequency and ratio values were used in descriptive statistics of the data, SPSS 22.0 program was used for the analyses.
Study Type Observational [Patient Registry]
Study Design Observational Model: Case-Crossover
Time Perspective: Prospective
Target Follow-Up Duration 5 Months
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Patients between 18 and 60 years in American Society of Anesthesiologists (ASA) I and II groups were included. Patients that had severe organ disease, allergies to study drugs, refused to participate in the study were excluded. Cases were randomized into the dexmedetomidine-propofol group (Group D, n=30) and ketamine-propofol group (Group K, n=30).
Condition Anesthesia; Reaction
Intervention Drug: Dexmedetomidine
Group D received 1mg/kg dexmedetomidine+0.5mg/kg propofol intravenous (iv) bolus, 0.5 μg/kg/h dexmedetomidine+ 0.5 mg/kg/h propfol infusion. Group K received 0.125 mL/kg bolus, 0.125 mL/kg/h ketamine+ propofol = ketofol infusion (ketofol was prepared with 4 mg propofol+2 mg ketamine).
Other Names:
  • propofol
  • ketamine
Study Groups/Cohorts Not Provided
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 Completed
Actual Enrollment
 (submitted: May 18, 2020)
60
Original Actual Enrollment Same as current
Actual Study Completion Date March 13, 2020
Actual Primary Completion Date February 20, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • ASA I-II group
  • 60 patients
  • between the ages of 18 and 60
  • planned to have upper gastrointestinal system (UGIS) endoscopy with sedation,

Exclusion Criteria:

  • severe heart, lung, liver disease
  • kidney failure,
  • bleeding diathesis
  • fever,
  • infection,
  • electrolyte disorder such as hypokalemia, hypocalcaemia, acid-base disorder, hypothermia, allergy to drugs to be used, and study those who refused to be included were excluded
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Turkey
Removed Location Countries  
 
Administrative Information
NCT Number NCT04399226
Other Study ID Numbers umutkan
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Plan Description: yes
Responsible Party Arzu Esen Tekeli, Yuzuncu Yıl University
Study Sponsor Yuzuncu Yıl University
Collaborators Not Provided
Investigators
Principal Investigator: Arzu Esen TEKELİ, MD Van Yuzuncu Yil University
PRS Account Yuzuncu Yıl University
Verification Date May 2020