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

NCT04399226 | Completed

• 1 other identifier: umutkan
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Anesthesia; Reaction

Keywords

Dexmedetomidine, Ketamine, Propofol, Sedation

Outcome Measures

Primary Outcomes (1)

• Demographic data

  no difference

  2 minutes

Secondary Outcomes (1)

• adverse events

  2 minutes

Other Outcomes (1)

• sedation depth

  2 minutes

Interventions

Dexmedetomidine DRUG

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

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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).

You may qualify if:

• ASA I-II group
• patients
• between the ages of 18 and 60
• planned to have upper gastrointestinal system (UGIS) endoscopy with sedation,

You may not qualify if:

• 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

Sponsors & Collaborators

• Yuzuncu Yil University: lead

Study Sites (1)

Van Yuzuncu Yil University

Van, Tuşba, 65000, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Dexmedetomidine; Propofol; Ketamine

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic

Study Officials

• Arzu Esen TEKELİ, MD

  Yuzuncu Yil University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 29, 2020
• First Posted: May 22, 2020
• Study Start: October 18, 2019
• Primary Completion: February 20, 2020
• Study Completion: March 13, 2020
• Last Updated: May 22, 2020

Record last verified: 2020-05

Locations

TU (1)