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

• Sponsor: Yuzuncu Yıl University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04399226
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Actual Duration (Months): 4.8
• Patients Per Site Per Month: 12.4

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Anesthesia; Reaction	Drug: Dexmedetomidine

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 Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 60 participants
• Observational Model: Case-Crossover
• Time Perspective: Prospective
• Official Title: Efficacy and Safety of Deksmedetomidine-propofol or Ketamine-propofol
• Actual Study Start Date: Oct 18, 2019
• Actual Primary Completion Date: Feb 20, 2020
• Actual Study Completion Date: Mar 13, 2020

Outcome Measures

Primary Outcome Measures

1. Demographic data [2 minutes]

   no difference

Secondary Outcome Measures

1. adverse events [2 minutes]

   Nausea, vomiting and allergic reaction, cough

Other Outcome Measures

1. sedation depth [2 minutes]

   Measured with BIS

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Van Yuzuncu Yil University	VAN	Tuşba	Turkey	65000

Sponsors and Collaborators

• Yuzuncu Yıl University

Investigators

• Principal Investigator: Arzu Esen TEKELİ, MD, Van Yuzuncu Yil University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Arzu Esen Tekeli, Assistant Professor, Yuzuncu Yıl University
• ClinicalTrials.gov Identifier: NCT04399226
• Other Study ID Numbers: umutkan
• First Posted: May 22, 2020
• Last Update Posted: May 22, 2020
• Last Verified: May 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Arzu Esen Tekeli, Assistant Professor, Yuzuncu Yıl University: Dexmedetomidine, Ketamine, Propofol, Sedation
• Additional relevant MeSH terms: Dexmedetomidine; Ketamine; Propofol

Study Results

No Results Posted as of May 22, 2020