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CompletedNCT04399226Updated May 22, 2020

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

An observational study in Anesthesia; Reaction, sponsored by Yuzuncu Yıl University. Completed at 1 site in Turkey. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-05-22.

Sponsored by Yuzuncu Yıl University · Observational

Study type
Observational
Model
Case-crossover
Time perspective
Prospective
Enrollment
60
Ages
18 Years to 60 Years
Sex
All
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Study summary

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

Read the 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.

02

Conditions studied

  • Anesthesia; Reaction

Keywords

  • Dexmedetomidine, Ketamine, Propofol, Sedation
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In context

Lead sponsor

Yuzuncu Yıl University is the lead sponsor of 124 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
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).

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

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
05

Study design

Observational model
Case-crossover
Time perspective
Prospective
Enrollment
60 participants (actual)
Target follow-up
5 Months
Patient registry
Yes

Interventions

  • DrugDexmedetomidine

    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).

    Also known as: propofol, ketamine

06

What researchers measure

Primary outcomes

  1. Demographic data

    no difference

    Time frame: 2 minutes

Secondary outcomes

  1. adverse events

    Nausea, vomiting and allergic reaction, cough

    Time frame: 2 minutes

Other outcomes

  1. sedation depth

    Measured with BIS

    Time frame: 2 minutes

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Study locations

1 site
  • Van Yuzuncu Yil University
    VAN, Tuşba 65000, Turkey
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References and documents

Individual participant data

Plan to share: Undecided — yes

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 22, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04399226
Lead sponsor
Yuzuncu Yıl University
Responsible party
Arzu Esen Tekeli (Assistant Professor, Yuzuncu Yıl University) — Principal investigator
First posted
May 22, 2020
Start date
Oct 18, 2019
Primary completion
Feb 20, 2020
Completion
Mar 13, 2020
Last update
May 22, 2020

Study contacts

Arzu Esen TEKELİ, MD
principal investigator · Van Yuzuncu Yil University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2020. You cannot join it, but the record below documents what was studied.

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