MedDataX Logo

Pre-procedural Anxiety and Sedation.

NCT ID: NCT01958151

Last Updated: 2013-10-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

75 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-01-31

Study Completion Date

2013-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Anxiety

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

colonoscopy deep sedation anxiety

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

State-Trait Anxiety Inventory Scores

Intervention Type OTHER

Patients are evaluated before the procedure with State-Trait Anxiety Inventory scores to determine the anxiety level.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

State-Trait Anxiety Inventory Scores

Patients are evaluated before the procedure with State-Trait Anxiety Inventory scores to determine the anxiety level.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Basak Ceyda MECO

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Basak Ceyda MECO

MD,DESA

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Basak Ceyda MECO, MD, DESA

Role: PRINCIPAL_INVESTIGATOR

Ankara University Faculty of Medicine

Mehmet Ayhan Kuzu, Prof

Role: STUDY_DIRECTOR

Ankara University Faculty of Medicine

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Ankara University Faculty of Medicine, Ibni Sina Hospital colonoscopy lab

Ankara, , Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

10-306-12

Identifier Type: -

Identifier Source: org_study_id