Clinical trial NCT01958151: Pre-procedural Anxiety and Sedation.
Official title: Does Pre-procedural Anxiety Affect the Consumption of Sedatives During Colonoscopy?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anxiety
Keywords: colonoscopy
deep sedation
anxiety
Lead sponsor: Ankara University
Sponsor class: OTHER
First posted: 2013-10-09
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 75 healthy patients undergoing elective colonoscopies as a screening test.

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.

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 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

Primary outcomes:
measure: To evaluate the effects of pre-procedural anxiety level on the dose of propofol needed for sedation during the procedure.
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara University Faculty of Medicine, Ibni Sina Hospital colonoscopy lab
Study officials:
affiliation: Ankara University Faculty of Medicine
name: Basak Ceyda MECO, MD, DESA
role: PRINCIPAL_INVESTIGATOR
affiliation: Ankara University Faculty of Medicine
name: Mehmet Ayhan Kuzu, Prof
role: STUDY_DIRECTOR
References: