Effects of Providing Preprint Preoperative Anesthetic Risk Information

This study is currently recruiting participants.

Verified by Mahidol University, January 2009

First Received: January 1, 2009 Last Updated: January 6, 2009 History of Changes

Sponsored by:	Mahidol University
Information provided by:	Mahidol University
ClinicalTrials.gov Identifier:	NCT00816699

Purpose

Proportion of patients in study group(preprint preoperative anesthetic risk should have more anxiety, more knowledge, and more cancellation than controlled group

Condition	Intervention	Phase
Pre Operative Anxiety	Other: preprint preoperative anesthetic risk information	Phase I Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Effects of Providing Preprint Preoperative Anesthetic Risk Information

Resource links provided by NLM:

MedlinePlus related topics: Anesthesia Anxiety

U.S. FDA Resources

Further study details as provided by Mahidol University:

Primary Outcome Measures:

Spielberger State Trait Anxiety Inventory Scale [ Time Frame: 5 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Knowledge, proportion of patients who cancel surgery, proportion who refuse regional anesthesia [ Time Frame: 5 days ] [ Designated as safety issue: No ]

Estimated Enrollment:	103
Study Start Date:	December 2008
Estimated Study Completion Date:	September 2010
Estimated Primary Completion Date:	August 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Placebo Comparator Routine anesthetic risk information	Other: preprint preoperative anesthetic risk information preprint preoperative anesthetic risk information
2: Active Comparator Preprint preoperative risk information	Other: preprint preoperative anesthetic risk information preprint preoperative anesthetic risk information

Eligibility

Ages Eligible for Study:	20 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Inpatients scheduled for surgery under general anesthesia with or without regional anesthesia
Low to moderate risk surgery

Exclusion Criteria:

Patient's refusal
Patients scheduled for cardiovascular surgery and neurosurgery
Patients with consciousness change following surgery
Emergency case
CNS or psychological diseases

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00816699

Locations

Thailand
Faculty of Medicine, Siriraj Hospital, Mahidol Unversity	Recruiting
Bangkok, Thailand, 10700
Contact: Suwannee Suraseranivongse, MD sisur@mahidol.ac.th

Sponsors and Collaborators

Mahidol University

Investigators

Principal Investigator:	Suwannee Suraseranivongse	Department of Anesthesiology, Siriraj Hospital
Principal Investigator:	Suwannee Suraseranivongse, MD	Department of Anesthesiology, Siriraj Hospital

More Information

Additional Information:

Mahidol University This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Faculty of Medicine Siriraj hospital, Mahidol University ( Effects of providing preprint preoperative anesthetic-risk information )
Study ID Numbers:	Si325/2008
Study First Received:	January 1, 2009
Last Updated:	January 6, 2009
ClinicalTrials.gov Identifier:	NCT00816699 History of Changes
Health Authority:	Thailand: Ethical Committee

Keywords provided by Mahidol University:

Anxiety
preprint anesthetic risk information

Study placed in the following topic categories:

Central Nervous System Depressants
Anesthetics

Additional relevant MeSH terms:

Therapeutic Uses
Physiological Effects of Drugs
Central Nervous System Depressants

Anesthetics
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 02, 2009