- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03114735
Effects of Preoperative Anxiety and Pain Sensitivity in Cases of Endoscopic Ultrasonography Received Sedoanalgesia
April 10, 2017 updated by: Ferda Yilmaz Inal, Istanbul Medeniyet University
The Effects of Preoperative Anxiety and Pain Sensitivity on the Intraoperative Hemodynamics, Consumption of Propofol and Postoperative Recovery in Cases of Endoscopic Ultrasonography (EUS) Received Sedoanalgesia
The objective of this study was to detect whether preoperative anxiety and pain sensitivity had effects on the consumption of anesthetics, time to achieve desired level of sedation, patient and endoscopist satisfaction, and postoperative recovery time and pain in deep sedation.
Study Overview
Status
Unknown
Conditions
Study Type
Observational
Enrollment (Anticipated)
80
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
patients scheduled for elective endoscopic ultrasonography with deep sedation
Description
Inclusion Criteria:
- ASA 1-2 category
- between the ages of 20 and 65
- patients who has an education level and mental state to complete the scale and questionnaire provided for assessment
Exclusion Criteria:
- patients who has a psychiatric and neurological disease and use psychiatric drugs and chronic alcohol intake
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
consumption of propofol(mg)
Time Frame: 1-3 hours
|
initial dose infusion of 1 mg.kg-1 , maintenance dose 2 mg/kg/h, additional dose 0,1mg/kg in case of insufficient sedation
|
1-3 hours
|
|
the heart rate(n/min)
Time Frame: 1-3 hours
|
During procedure
|
1-3 hours
|
|
arterial pressure(mmHg)
Time Frame: 1-3 hours
|
During procedure
|
1-3 hours
|
|
peripheral oxygen saturation(%)
Time Frame: 1-3 hours
|
during procedure
|
1-3 hours
|
|
postoperative nausea and vomiting (Numeric Rank Score)
Time Frame: 1-3 hours
|
After procedure
|
1-3 hours
|
|
Post-procedure pain(Visual Analog Score)
Time Frame: 1-3 hours
|
After procedure
|
1-3 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ANTICIPATED)
April 15, 2017
Primary Completion (ANTICIPATED)
May 1, 2017
Study Completion (ANTICIPATED)
June 1, 2017
Study Registration Dates
First Submitted
March 25, 2017
First Submitted That Met QC Criteria
April 10, 2017
First Posted (ACTUAL)
April 14, 2017
Study Record Updates
Last Update Posted (ACTUAL)
April 14, 2017
Last Update Submitted That Met QC Criteria
April 10, 2017
Last Verified
March 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 71306642-050.01.04-21/28
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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