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Ketamine for Endoscopic Sedation in Outpatient Adult Endoscopy.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03461718
Recruitment Status : Completed
First Posted : March 12, 2018
Last Update Posted : July 8, 2020
Sponsor:
Information provided by (Responsible Party):
Jerome Edelson, Brooke Army Medical Center

Tracking Information
First Submitted Date  ICMJE February 23, 2018
First Posted Date  ICMJE March 12, 2018
Last Update Posted Date July 8, 2020
Actual Study Start Date  ICMJE March 5, 2018
Actual Primary Completion Date October 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 9, 2018)
Provider satisfaction [ Time Frame: Measured within 15 minutes post proceudre ]
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 9, 2018)
  • Sedation time [ Time Frame: During the procedure ]
    Time from sedation administration until procedure start, will be measured in minutes
  • Time to cecum (for colonoscopy) [ Time Frame: During the procedure ]
    Time required for endoscopist to reach the cecum, will be measured in minutes
  • Total dose of medications given [ Time Frame: During the procedure ]
    All doses of medications will be summed and reported.
  • Overall procedure time [ Time Frame: During the procedure ]
    The time from procedure start to procedure completion will be measured in minutes
  • Adverse events [ Time Frame: During the procedure ]
    Are detailed in the protocol. We will be recording the presence or absence of adverse events.
  • Changes in vital signs [ Time Frame: During the procedure ]
    As defined in the protocol. We will be recording all vital signs for later analysis.
  • Need for additional medications, ie reversal agents [ Time Frame: During the procedure ]
    Will be measured as yes or no, specific dose and medication will be recorded for analysis.
  • Patient Satisfaction [ Time Frame: 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. ]
    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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ketamine for Endoscopic Sedation in Outpatient Adult Endoscopy.
Official Title  ICMJE Ketamine as a Sedation Adjunct for Endoscopic Procedures
Brief Summary 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.
Detailed Description In this study, the investigators plan to conduct a single blinded randomized controlled trial in the Gastroenterology Service to demonstrate the efficacy of ketamine and its utility in moderate sedation. Patients presenting to the endoscopy lab for esophagogastroduodenoscopy (EGD) and/or colonoscopy who meet inclusion criteria will be approached, and if amenable, will be consented and enrolled. Patients will be randomized to receive either a ketamine loading dose and then subsequent doses IV ketamine and midazolam 1mg IV prior to administration of ketamine or standard fentanyl/midazolam moderate sedation during their procedure. Participants will then undergo the planned procedure. The primary outcome will be patient satisfaction, which will be measured using the validated "Patient Satisfaction with Sedation" instrument (PSSI). A number of secondary outcomes will include the following: (1) provider satisfaction (measured using and the "Clinician Satisfaction with Sedation" instrument (CSSI), (2) the time from sedation administration to procedure start (when the scope is inserted), (3) the time from sedation to recovery (defined as the time from the end of the procedure until the patient meets discharge criteria from the recovery area), (4) time to cecum (for colonoscopy) total doses of medications given (midazolam, fentanyl, and ketamine), (5) overall time of the procedure, (6) adverse events, (7) changes in vital signs, (8) and the need for additional medications, in particular reversal agents.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE
  • Administration and Dosage of Ketamine
  • Endoscopic Sedation
Intervention  ICMJE
  • Drug: Ketamine
    Experimental arm for sedation.
  • Drug: Midazolam injection
    Part of standard sedation regimen and anxiolysis and for minimization of emergence reaction
  • Drug: Fentanyl
    Part of standard sedation regimen
Study Arms  ICMJE
  • Experimental: Ketamine
    Group will receive ketamine 0.5-1mg/kg for a loading dose then subsequent IV pushes of 10-20mg for maintenance. 1mg IV of midazolam will be administered prior to ketamine for anxiolysis and to help minimize emergence reaction.
    Interventions:
    • Drug: Ketamine
    • Drug: Midazolam injection
  • Active Comparator: Control
    This group will receive midazolam and fentanyl alternated as currently preformed for endoscopy.
    Interventions:
    • Drug: Midazolam injection
    • Drug: Fentanyl
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 9, 2018)
66
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 1, 2019
Actual Primary Completion Date October 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03461718
Other Study ID Numbers  ICMJE C.2017.175
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Jerome Edelson, Brooke Army Medical Center
Study Sponsor  ICMJE Brooke Army Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jerome C Edelson, MD BAMC
Study Chair: John G Gancayco, MD BAMC
Study Director: Cyrus V Edelson, MD BAMC
PRS Account Brooke Army Medical Center
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP