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

Completed

• Conditions: Anesthesia; Reaction

• Registration Number: NCT04399226
• Lead Sponsor: Yuzuncu Yıl University

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 Timeline

• Study Start: 2019-10-18
• Primary Completion: 2020-02-20
• Study Completion: 2020-03-13
• Study First Submitted: 2020-04-29
• Status Verified: 2020-05
• Study First Submitted QC: 2020-05-18
• Last Update Submitted: 2020-05-18
• Study First Posted: 2020-05-22
• Last Update Posted: 2020-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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,

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Demographic data	2 minutes	no difference

Secondary Outcome Measures

Name	Time	Method
adverse events	2 minutes	Nausea, vomiting and allergic reaction, cough

Trial Locations

Locations (1)

Van Yuzuncu Yil University; 🇹🇷 VAN, Tuşba, Turkey