Patient Satisfaction Clinical Trial
Official title:
The Use of Ketamine for Conscious Sedation in Flexible Bronchoscopy
Verified date | December 2023 |
Source | Brooke Army Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
In this study, the investigators plan to conduct a single blinded randomized controlled trial in the Pulmonary Service to demonstrate the efficacy of ketamine and its utility in moderate sedation. Patients presenting for bronchoscopy who meet inclusion criteria will be approached, and if amenable, will be consented and enrolled. Patients will be randomized to receive either 1 mg of midazolam and ketamine 0.25 to 0.5 mg/kg loading dose with subsequent doses of 10-20 mg IV or standard fentanyl and midazolam in 25mcg and 1mg increments respectively for moderate sedation during their procedure. The primary outcome will be patient satisfaction, which will be measured a using patient clinical satisfaction form. A number of secondary outcomes will include the following: (1) provider satisfaction (2) the time from sedation administration to procedure start (when the scope is inserted), (3) the time from sedation to scope removal from the trachea (4) the time from sedation to discharge (defined as the time from the end of the procedure until the patient meets discharge criteria from the recovery area), (5) total dose of medications given (including midazolam, fentanyl, and ketamine), (6) adverse events, (7) vital signs, (8) and the need for additional medications, in particular reversal agents.
Status | Completed |
Enrollment | 66 |
Est. completion date | October 30, 2023 |
Est. primary completion date | October 30, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: - Patients age 18 to 75 years who present to the pulmonary clinic for bronchoscopy and considered for airway survey, transbronchial biopsy, endobronchial biopsy, or bronchoalveolar lavage. - Provider performing the bronchoscopy Exclusion Criteria: - Systolic blood pressure over 180mmHg and/or diastolic blood pressure over 110 on two consecutive readings - Tachycardia greater than 120 beats/minute on two consecutive measurements - Any allergy to ketamine, fentanyl, or midazolam - Patient is pregnant or refuses pregnancy test,in women of child-bearing potential* - American Society of Anesthesiologists (ASA) score > 3 - Presence of a history of psychosis, hallucinations, and/or a psychotic disorder |
Country | Name | City | State |
---|---|---|---|
United States | Brooke Army Medical Center | San Antonio | Texas |
Lead Sponsor | Collaborator |
---|---|
Brooke Army Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | A patient's history of alcohol consumption. | The amount of alcoholic drinks consumed on a daily basis. The amount of sedating medication will then be recorded and a comparison will be made between patients who actively use alcohol to those who do not. | at enrollment and during the procedure | |
Other | A patient's history of chronic opioid use. | The amount of opioids used if patient has a current prescription for opioids. The amount of sedating medication will then be recorded and a comparison will be made between patients who actively use opioids to those who do not. | at enrollment and during the procedure | |
Other | A patient's history of chronic benzodiazepine use. | The amount of benzodiazepines will be recorded. The amount of sedating medication will then be recorded and a comparison will be made between patients who actively use benzodiazepines to those who do not. | at enrollment and during the procedure | |
Primary | Patient sedation satisfaction with sedation instrument | A twenty one question survey assessing patient satisfaction using a 7-point Likert Scale. A "1" on the scale would indicated very satisfied, 2 - satisfied, 3 - somewhat satisfied, 4 - neither satisfied nor dissatisfied, 5 - somewhat dissatisfied, 6 - dissatisfied, and 7- very dissatisfied. | A survey will be conducted upon the completion of the procedure. | |
Primary | Patient sedation satisfaction with sedation instrument | A twenty one question survey assessing patient satisfaction using a 7-point Likert Scale. A "1" on the scale would indicated very satisfied, 2 - satisfied, 3 - somewhat satisfied, 4 - neither satisfied nor dissatisfied, 5 - somewhat dissatisfied, 6 - dissatisfied, and 7- very dissatisfied. | A follow up survey will be conducted 24-48 hours after the completion of the bronchoscopy. The average of both survey's will then be used to score the overall satisfaction of sedation. | |
Secondary | Clinician satisfaction with sedation instrument | A twenty one question survey assessing patient satisfaction using a 7-point Likert Scale. A 1 indicates very satisfied, 2 - satisfied, 3 - somewhat satisfied, 4 - neither satisfied nor dissatisfied, 5 - somewhat dissatisfied, 6 - dissatisfied, and 7- very dissatisfied. | Upon completion of the procedure | |
Secondary | time from sedation administration to procedure start | time for when the initial sedation is given to when the scope is inserted | during the procedure | |
Secondary | procedural time | Time from when sedation is given to when the scope is removed from the airway | during the procedure | |
Secondary | Total time | Time from when sedation is first given to when the patient meets discharge criteria | during the procedure | |
Secondary | Total dose of medications given | Total amount of medication given, ketamine will be measured in milligrams (mg), versed in mg, and fentanyl in micrograms with total dose of each calculated, direct comparison will not be possible however will allow clinicians to evaluate relative sedatives used. | during the procedure | |
Secondary | Blood pressure | Blood pressure - measured in mmHg | during the procedure | |
Secondary | Heart Rate | measured in beats per min (BPM) | during the procedure | |
Secondary | Oxygen Saturation | measured as SPo2 | during the procedure | |
Secondary | End Tidal Co2 | measured in mmHg | during the procedure | |
Secondary | Respiratory Rate | measured as the number of breaths per minute | during the procedure |
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