Pre-procedural Anxiety and Sedation.

Anxiety Clinical Trial

Official title:

Does Pre-procedural Anxiety Affect the Consumption of Sedatives During Colonoscopy?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01958151
• Other study ID #: 10-306-12
• Status: Completed
• Phase: N/A
• First received: September 25, 2013
• Last updated: October 8, 2013
• Start date: January 2013
• Est. completion date: September 2013

Study information

• Verified date: October 2013
• Source: Ankara University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Description:

Patients scheduled for elective colonoscopy for screening are enrolled. On the day of the procedure, demographic data are collected and all patients are asked to complete the Spielberger State-trait Anxiety Inventory (STAI-I and STAI-II) in an isolated, calm room before being transferred to the procedure room.

All patients are monitored with electrocardiogram, pulse oximetry, noninvasive blood pressure and bispectral index measurement at 5-min intervals.

Oxygen is administered at 4 L/min via a face mask, Propofol 2% infusion is started via an effect-site target controlled infusion system (Marsh model).

Once the patient reaches the desired level of sedation as determined by BIS value of 60, the procedure is started.

This monitorization and sedation protocol is the routine management of outpatient colonoscopies and gastroscopies in our institution.

For this study the patients' anxiety levels are evaluated with the STAI score. This is not an intervention but an evaluation of the patients. Drug dosing or sedation management are not adjusted according to the anxiety scores but are calculated with the patients' weight.

During the procedure:

• hemodynamic parameters

• the total propofol dosage

• the number of TCI interventions

• complications (respiratory depression, need for ventilation, nausea, vomiting, laryngospasm, and agitation)

• the procedure duration

• surgeon satisfaction with sedation instrument scores are recorded.

These collected data are studies to determine a correlation between the propofol dose and the pre-procedural anxiety of the patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• American Society of Anaesthesiology Physiologic assessment score I-II patients

• 18-65 years old

• planned elective colonoscopy under sedation

Exclusion Criteria:

• the use of anxiolytic medications

• history of colonic resection or any intraabdominal surgery

• predicted allergy to propofol

• patients refusing sedation

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders

Intervention

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

Locations

Country	Name	City	State
Turkey	Ankara University Faculty of Medicine, Ibni Sina Hospital colonoscopy lab	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Basak Ceyda MECO

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No