Administration and Dosage of Ketamine Clinical Trial
Official title:
Ketamine as a Sedation Adjunct for Endoscopic Procedures
| Verified date | July 2020 |
| Source | Brooke Army Medical Center |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
We will be investigating the use of ketamine in sedation for endoscopic procedures, specifically outpatient endoscopy including esophagoduodenoscopy (EGD) and colonoscopy. Participants will be randomized to one of two arms including conventional moderate sedation with midazolam and fentanyl or the ketamine arm. They will then undergo the planned procedure. Physicians preforming the procedure will be surveyed following the procedure and patients will be surveyed twice, once after meeting criteria for discharge on day of the procedure and a second time 48 hours following the procedure.
| Status | Completed |
| Enrollment | 66 |
| Est. completion date | October 1, 2019 |
| Est. primary completion date | October 1, 2019 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 65 Years |
| Eligibility |
Inclusion Criteria: - Patients age 18 to 65 years who present to the GI clinic for an EGD or colonoscopy Exclusion Criteria: - Poor vital sign stability - Hypoxia: O2 < 92%, - Hypotension, hypertension, heart rate and respiratory rates greater than 20% above or below normal as dictated by normal ranges in SAMMC protocol - 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 - History of increased intracranial pressure/ hypertensive hydrocephalus within the last 3 months - Active pulmonary infection or disease. - History of airway instability, tracheal surgery, or tracheal stenosis. - * Not applicable if patient is a female over 50 years old or has had a hysterectomy and/or oophorectomy |
| Country | Name | City | State |
|---|---|---|---|
| United States | Brooke Army Medical Center | Fort Sam Houston | Texas |
| Lead Sponsor | Collaborator |
|---|---|
| Brooke Army Medical Center |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Provider satisfaction | Measured with CSSI score. This consists of a questionnaire administered to the provider following the procedure with questions detailing different aspects of the procedure. Answers will be summed and the scores are normalized to a scale of 0-100 (high scores denote higher satisfaction). | Measured within 15 minutes post proceudre | |
| Secondary | Sedation time | Time from sedation administration until procedure start, will be measured in minutes | During the procedure | |
| Secondary | Time to cecum (for colonoscopy) | Time required for endoscopist to reach the cecum, will be measured in minutes | During the procedure | |
| Secondary | Total dose of medications given | All doses of medications will be summed and reported. | During the procedure | |
| Secondary | Overall procedure time | The time from procedure start to procedure completion will be measured in minutes | During the procedure | |
| Secondary | Adverse events | Are detailed in the protocol. We will be recording the presence or absence of adverse events. | During the procedure | |
| Secondary | Changes in vital signs | As defined in the protocol. We will be recording all vital signs for later analysis. | During the procedure | |
| Secondary | Need for additional medications, ie reversal agents | Will be measured as yes or no, specific dose and medication will be recorded for analysis. | During the procedure | |
| Secondary | Patient Satisfaction | Measured with PSSI score. This consists of a questionnaire administered to the provider following the procedure with questions detailing different aspects of the procedure. Answers will be summed and the scores are normalized to a scale of 0-100 (high scores denote higher satisfaction). Criteria for discharge are at least 30 minutes elapsed since the last dose of sedative medication was administered, presence of protective reflexes (swallow and gag), stable vital signs, patient passes trial of ambulation (if was ambulating prior to procedure, a responsible adult is present to drive patient home and remain with the patient the length of two half-lives of the medications administered for sedation, and there are no staff concerns about safety. After the patient meets discharge criteria, a survey will be preformed. It will also be repeated once at the 48 hour post-procedure time. Conclusion of the two surveys concludes patient participation in the study. | After patient reaches criteria for discharge as listed above, a survey will be preformed. It will also be preformed 48 hours post procedure with the patients being called. Two surveys will end patient participation in the study. |