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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03832309
Other study ID # 2017196
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date November 21, 2017
Est. completion date June 21, 2021

Study information

Verified date April 2022
Source CHRISTUS Health
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The objectives of this study are first to determine if the power of suggestion will decrease the frequency and severity of emergence reactions after procedural sedation and analgesia with ketamine in the setting of the emergency department. Second, to determine if people dream about what they were thinking about when they were induced with ketamine.


Description:

The proposed research will be single blinded (patient) randomized controlled trial with a retrospective component to test the hypothesis that the power of suggestion will reduce the frequency and severity of emergence reactions, even in the setting of the emergency department. The study will be conducted in the emergency department at CHRISTU Spohn Shoreline Hospital. CHRISTUS Spohn Shore hospital is the region's primary acute care center. It houses the Chest Pain, Stroke, and Cancer Centers of CHRISTUS Spohn, and the only level II trauma center in south Texas. It is a major teaching affiliate of Texas A&M medical school, and serves an inner-city population.


Recruitment information / eligibility

Status Terminated
Enrollment 38
Est. completion date June 21, 2021
Est. primary completion date June 21, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Be at least 18 years of age - Required need for procedural sedation and analgesia Exclusion Criteria: - Age< 18 - Hypertension - Raised Intracranial pressure - Major psychological disorders - Procedures involving laryngel manipulations - History of Laryngeal sapsm History of adverse reactions to ketamine

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Do we speak to them in a way that convinces them to have the dream
During induction, and depending on what group they are randomized to, the physician will speak to them about having a dream while on the drug
Speaking to them as a regualar person
During induction, if the patient is in group 1, the resident performing procedural sedation will remind the patient about what the patient wanted to dream and ask them to focus on that as the ketamine is being administered. If the patient is in group 2, the resident performing procedural sedation will give no specific instruction to the patient at this point.

Locations

Country Name City State
United States CHRISTUS Health Corpus Christi Texas

Sponsors (1)

Lead Sponsor Collaborator
CHRISTUS Health

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary T-Test Data gathered from post sedation questionnaire, specifically question 5, will be analyzed by comparing the two means of group one and group two using a student's T test, 24 months
Primary STAI-6 To ensure two groups are similar to each other -demographic data, the pre and post opt sedation VAS scores, and the STAI-6 information. 24 months
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