Pre-procedural Anxiety and Sedation.

NCT01958151 | Completed

• 1 other identifier: 10-306-12
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

Colonoscopy is an outpatient procedure performed frequently as a screening test for diagnosis and treatment of a wide range of gastrointestinal problems. It is often viewed as an invasive procedure with the potential for embarrassment, discomfort, and worry. Such fears can result in anxiety that may decrease the tolerance and cooperation of the patient, limit the success of the procedure, and increase the likelihood of complications. Therefore, colonoscopy is frequently performed under sedation. The anxiety level of the patient before the procedure may increase the requirement for sedation. It is important for the anesthesiologist to predict the effective dosages of sedation before the procedure to ensure rapid and comfortable sedation as well as prompt recovery and discharge of the patient. This prospective cohort study is planned to evaluate the effects of pre-procedural anxiety level on the dose of propofol needed for patient and surgeon satisfaction during colonoscopy.

Conditions

Anxiety

Keywords

colonoscopy; deep sedation; anxiety

Outcome Measures

Primary Outcomes (1)

• To evaluate the effects of pre-procedural anxiety level on the dose of propofol needed for sedation during the procedure.

  The sedation protocol applied in this study is our routin approach for all outpatient colonoscopies and endoscopies. All patients are informed about the procedures and monitorized (EKG, spO2, Bispectral index, blood pressure). After that, the sedation protocol is started and once the appropriate BIS value is reached the procedure is started. For this study all patients were asked to complete the STAI scores to evaluate the pre-procedural anxiety. This is not an intervention but an evaluation of the patients' anxiety. The primary outcome measure is to evaluate the dose of propofol used in each patient and to find out if there is a correlation between the pre-procedural anxiety and the dose of propofol.

  The anxiety of all patients is evaluated at the day of the procedure. The procedure is then performed under sedation. Once the procedure is ended and all patients are fully awake, study data are collected and patients are discharged home.

Study Arms (1)

Sedated colonoscopy

Planned colonoscopies for screening under propofol sedation titrated to reach a bispectal index value of 60. Anxiety levels are assessed before the procedure with State-Trait Anxiety Inventory Scores.

Other: State-Trait Anxiety Inventory Scores

Interventions

State-Trait Anxiety Inventory Scores OTHER

Patients are evaluated before the procedure with State-Trait Anxiety Inventory scores to determine the anxiety level.

Sedated colonoscopy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

75 healthy patients undergoing elective colonoscopies as a screening test.

You may qualify if:

• American Society of Anaesthesiology Physiologic assessment score I-II patients
• years old
• planned elective colonoscopy under sedation

You may not qualify if:

• the use of anxiolytic medications
• history of colonic resection or any intraabdominal surgery
• predicted allergy to propofol
• patients refusing sedation

Sponsors & Collaborators

• Basak Ceyda MECO: lead

Study Sites (1)

Ankara University Faculty of Medicine, Ibni Sina Hospital colonoscopy lab

Ankara, 06700, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Basak Ceyda MECO, MD, DESA

  Ankara University Faculty of Medicine

  PRINCIPAL INVESTIGATOR

• Mehmet Ayhan Kuzu, Prof

  Ankara University Faculty of Medicine

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD,DESA

Study Record Dates

• First Submitted: September 25, 2013
• First Posted: October 9, 2013
• Study Start: January 1, 2013
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: October 9, 2013

Record last verified: 2013-10

Locations

TU (1)