Pre-procedural Anxiety and Sedation.
Condition: Anxiety
MeSH terms: Anxiety Disorders
Study type: Observational [Patient Registry]

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.
    

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.
    

Intervention name(s): State-Trait Anxiety Inventory Scores
Intervention type(s): Other
Intervention description(s): Patients are evaluated before the procedure with State-Trait Anxiety Inventory scores to determine the anxiety level.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        75 healthy patients undergoing elective colonoscopies as a screening test.
      
Keywords: colonoscopy; deep sedation; anxiety