Pre-procedural Anxiety and Sedation.

October 8, 2013 updated by: Basak Ceyda MECO

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Actual)

75

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey, 06700
        • Ankara University Faculty of Medicine, Ibni Sina Hospital colonoscopy lab

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

75 healthy patients undergoing elective colonoscopies as a screening test.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Patients are evaluated before the procedure with State-Trait Anxiety Inventory scores to determine the anxiety level.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To evaluate the effects of pre-procedural anxiety level on the dose of propofol needed for sedation during the procedure.
Time Frame: 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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Basak Ceyda MECO

Investigators

  • Study Director: Mehmet Ayhan Kuzu, Prof, Ankara University Faculty of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

September 1, 2013

Study Completion (Actual)

September 1, 2013

Study Registration Dates

First Submitted

September 25, 2013

First Submitted That Met QC Criteria

October 8, 2013

First Posted (Estimate)

October 9, 2013

Study Record Updates

Last Update Posted (Estimate)

October 9, 2013

Last Update Submitted That Met QC Criteria

October 8, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10-306-12

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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