SedoanalgesiaNCT03114735
Effects of Preoperative Anxiety and Pain Sensitivity in Cases of Endoscopic Ultrasonography Received Sedoanalgesia
An observational study of Sedoanalgesia, run by Istanbul Medeniyet University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Sedoanalgesia
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 15 Apr 2017to 1 Jun 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- Adult, Older adult
Study population: patients scheduled for elective endoscopic ultrasonography with deep sedation
Who may be able to join
- 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
Who cannot join
- patients who has a psychiatric and neurological disease and use psychiatric drugs and chronic alcohol intake
About this study
Official title: 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.
- Conditions
- Sedoanalgesia
What is being measured
The primary outcome is the main question the study is designed to answer.
consumption of propofol(mg)
initial dose infusion of 1 mg.kg-1 , maintenance dose 2 mg/kg/h, additional dose 0,1mg/kg in case of insufficient sedation
Measured: 1-3 hours
the heart rate(n/min)
During procedure
Measured: 1-3 hours
arterial pressure(mmHg)
During procedure
Measured: 1-3 hours
peripheral oxygen saturation(%)
during procedure
Measured: 1-3 hours
postoperative nausea and vomiting (Numeric Rank Score)
After procedure
Measured: 1-3 hours
Post-procedure pain(Visual Analog Score)
After procedure
Measured: 1-3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2017
- Study start15 Apr 2017 (estimated)
- Primary completion1 May 2017 (estimated)
- Study completion1 Jun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SedoanalgesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul Medeniyet University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ferda Yilmaz Inal, Istanbul Medeniyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03114735
- Sponsor's protocol ID
- 71306642-050.01.04-21/28
- Status last verified
- Mar 2017
- First submitted
- 25 Mar 2017
- Last updated
- 14 Apr 2017
- Results posted
- No
Publications
Yilmaz Inal F, Yilmaz Camgoz Y, Daskaya H, Kocoglu H. The Effect of Preoperative Anxiety and Pain Sensitivity on Preoperative Hemodynamics, Propofol Consumption, and Postoperative Recovery and Pain in Endoscopic Ultrasonography. Pain Ther. 2021 Dec;10(2):1283-1293. doi: 10.1007/s40122-021-00292-7. Epub 2021 Jul 22.
PubMed 34292516
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03114735
- Acronym / sponsor ID
- 71306642-050.01.04-21/28
- Conditions
- Sedoanalgesia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Istanbul Medeniyet UniversityUniversity, hospital or other
- Study start
- 15 Apr 2017 (estimated)
- Primary completion
- 1 May 2017 (estimated)
- Study completion
- 1 Jun 2017 (estimated)
- First posted
- 14 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- patients scheduled for elective endoscopic ultrasonography with deep sedation
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- patients who has a psychiatric and neurological disease and use psychiatric drugs and chronic alcohol intake
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
the heart rate(n/min)
Time frame: 1-3 hours
During procedure
arterial pressure(mmHg)
Time frame: 1-3 hours
During procedure
peripheral oxygen saturation(%)
Time frame: 1-3 hours
during procedure
postoperative nausea and vomiting (Numeric Rank Score)
Time frame: 1-3 hours
After procedure
Post-procedure pain(Visual Analog Score)
Time frame: 1-3 hours
After procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2017.
- Derived from this study: PubMed 34292516Yilmaz Inal F, Yilmaz Camgoz Y, Daskaya H, Kocoglu H. The Effect of Preoperative Anxiety and Pain Sensitivity on Preoperative Hemodynamics, Propofol Consumption, and Postoperative Recovery and Pain in Endoscopic Ultrasonography. Pain Ther. 2021 Dec;10(2):1283-1293. doi: 10.1007/s40122-021-00292-7. Epub 2021 Jul 22.
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Enrolling by invitation
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Sedoanalgesia, run by Istanbul Medeniyet University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
consumption of propofol(mg) (time frame: 1-3 hours). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03114735, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2017.