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

NCT ID: NCT04399226

Last Updated: 2020-05-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-10-18
• Study Completion Date: 2020-03-13

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.

Conditions

Anesthesia; Reaction

Study Design

• Observational Model Type: CASE_CROSSOVER
• Study Time Perspective: PROSPECTIVE

Interventions

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).

Intervention Type: DRUG

Other Intervention Names

propofol; ketamine

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Yuzuncu Yıl University

OTHER

Sponsor Role: lead

Responsible Party

Arzu Esen Tekeli

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Arzu Esen TEKELİ, MD

Role: PRINCIPAL_INVESTIGATOR

Yuzuncu Yıl University

Locations

Van Yuzuncu Yil University

Van, Tuşba, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

umutkan

Identifier Type: -

Identifier Source: org_study_id