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OpenTrials
Completed

NCT Number: NCT04399226

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

Sedation with dexmedetomidine-propofol or ketamine-propofol was planned in patients with upper gastrointestinal endoscopy.

Completed

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Van Yuzuncu Yil University

Van, Tuşba, 65000, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexmedetomidine

Drug

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

Primary outcomes

  1. Demographic data

    Time frame: 2 minutes

    no difference

Secondary outcomes

  1. adverse events

    Time frame: 2 minutes

    Nausea, vomiting and allergic reaction, cough

Other outcomes

  1. sedation depth

    Time frame: 2 minutes

    Measured with BIS

Sponsors and collaborators

Lead sponsor

Yuzuncu Yil University

Other

Registry information

Official study title

Efficacy and Safety of Deksmedetomidine-propofol or Ketamine-propofol

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
May 22, 2020
Registry last updated
May 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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