Effects of Preoperative Anxiety and Pain Sensitivity in Cases of Endoscopic Ultrasonography Received Sedoanalgesia

Sedoanalgesia Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03114735
• Other study ID #: 71306642-050.01.04-21/28
• Status: Not yet recruiting
• Phase: N/A
• First received: March 25, 2017
• Last updated: April 10, 2017
• Start date: April 15, 2017
• Est. completion date: June 1, 2017

Study information

• Verified date: March 2017
• Source: Istanbul Medeniyet University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: June 1, 2017
• Est. primary completion date: May 1, 2017
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Sedoanalgesia

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul Medeniyet University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	the heart rate(n/min)	During procedure	1-3 hours
Primary	arterial pressure(mmHg)	During procedure	1-3 hours
Primary	peripheral oxygen saturation(%)	during procedure	1-3 hours
Primary	postoperative nausea and vomiting (Numeric Rank Score)	After procedure	1-3 hours
Primary	Post-procedure pain(Visual Analog Score)	After procedure	1-3 hours