NCT03114735

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2017

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 25, 2017

Completed
20 days until next milestone

First Posted

Study publicly available on registry

April 14, 2017

Completed
1 day until next milestone

Study Start

First participant enrolled

April 15, 2017

Completed
16 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

April 14, 2017

Status Verified

March 1, 2017

Enrollment Period

16 days

First QC Date

March 25, 2017

Last Update Submit

April 10, 2017

Conditions

Sedoanalgesia

Outcome Measures

Primary Outcomes (6)

  • 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

    1-3 hours

  • the heart rate(n/min)

    During procedure

    1-3 hours

  • arterial pressure(mmHg)

    During procedure

    1-3 hours

  • peripheral oxygen saturation(%)

    during procedure

    1-3 hours

  • postoperative nausea and vomiting (Numeric Rank Score)

    After procedure

    1-3 hours

  • Post-procedure pain(Visual Analog Score)

    After procedure

    1-3 hours

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients scheduled for elective endoscopic ultrasonography with deep sedation

You may qualify if:

  • 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

You may not qualify if:

  • patients who has a psychiatric and neurological disease and use psychiatric drugs and chronic alcohol intake

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 34292516DERIVED

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 25, 2017

First Posted

April 14, 2017

Study Start

April 15, 2017

Primary Completion

May 1, 2017

Study Completion

June 1, 2017

Last Updated

April 14, 2017

Record last verified: 2017-03