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

Efficacy and Safety of Deksmedetomidine-propofol or Ketamine-propofol

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04399226
Enrollment
60
Registered
2020-05-22
Start date
2019-10-18
Completion date
2020-03-13
Last updated
2020-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia; Reaction

Keywords

Dexmedetomidine, Ketamine, Propofol, Sedation

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.

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).

Sponsors

Yuzuncu Yil University
Lead SponsorOTHER

Study design

Observational model
CASE_CROSSOVER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Demographic data2 minutesno difference

Secondary

MeasureTime frameDescription
adverse events2 minutesNausea, vomiting and allergic reaction, cough

Other

MeasureTime frameDescription
sedation depth2 minutesMeasured with BIS

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026