Pre-procedural Anxiety and Sedation.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Basak Ceyda MECO, Ankara University
ClinicalTrials.gov Identifier:
NCT01958151
First received: September 25, 2013
Last updated: October 8, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention
Anxiety
Other: State-Trait Anxiety Inventory Scores

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Day
Official Title: Does Pre-procedural Anxiety Affect the Consumption of Sedatives During Colonoscopy?

Resource links provided by NLM:


Further study details as provided by Ankara University:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    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.


Enrollment: 75
Study Start Date: January 2013
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

75 healthy patients undergoing elective colonoscopies as a screening test.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01958151

Locations
Turkey
Ankara University Faculty of Medicine, Ibni Sina Hospital colonoscopy lab
Ankara, Turkey, 06700
Sponsors and Collaborators
Basak Ceyda MECO
Investigators
Principal Investigator: Basak Ceyda MECO, MD, DESA Ankara University Faculty of Medicine
Study Director: Mehmet Ayhan Kuzu, Prof Ankara University Faculty of Medicine
  More Information

No publications provided

Responsible Party: Basak Ceyda MECO, MD,DESA, Ankara University
ClinicalTrials.gov Identifier: NCT01958151     History of Changes
Other Study ID Numbers: 10-306-12
Study First Received: September 25, 2013
Last Updated: October 8, 2013
Health Authority: Turkey: Ethics Committee

Keywords provided by Ankara University:
colonoscopy
deep sedation
anxiety

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 18, 2014