Ignite Creation Date:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2026-04-12 @ 11:56 PM
Study NCT ID:
NCT01958151
Status:
COMPLETED
Last Update Posted:
2013-10-09
First Post:
2013-09-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pre-procedural Anxiety and Sedation.
Sponsor:
Basak Ceyda MECO
Organization:
Study Overview
Official Title:
Does Pre-procedural Anxiety Affect the Consumption of Sedatives During Colonoscopy?
Status:
COMPLETED
Status Verified Date:
2013-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: