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

Anesthesia; Reaction Clinical Trial

Official title:

Efficacy and Safety of Deksmedetomidine-propofol or Ketamine-propofol

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04399226
• Other study ID #: umutkan
• Status: Completed
• Start date: October 18, 2019
• Est. completion date: March 13, 2020

Study information

• Verified date: May 2020
• Source: Yuzuncu Yil University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 13, 2020
• Est. primary completion date: February 20, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• 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).

Locations

Country	Name	City	State
Turkey	Van Yuzuncu Yil University	VAN	Tusba

Sponsors (1)

Lead Sponsor	Collaborator
Yuzuncu Yil University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	sedation depth	Measured with BIS	2 minutes
Primary	Demographic data	no difference	2 minutes
Secondary	adverse events	Nausea, vomiting and allergic reaction, cough	2 minutes