Ketamine for Endoscopic Sedation in Outpatient Adult Endoscopy.

• ClinicalTrials.gov Identifier: NCT03461718
• Recruitment Status: Completed
• First Posted: March 12, 2018
• Last Update Posted: July 8, 2020
• Sponsor: Brooke Army Medical Center
• Information provided by (Responsible Party): Jerome Edelson, Brooke Army Medical Center

Tracking Information

• First Submitted Date: February 23, 2018
• First Posted Date: March 12, 2018
• Last Update Posted Date: July 8, 2020
• Actual Study Start Date: March 5, 2018
• Actual Primary Completion Date: October 1, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Ketamine for Endoscopic Sedation in Outpatient Adult Endoscopy.
• Official Title: 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: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Participant); Primary Purpose: Treatment

Condition

• Administration and Dosage of Ketamine
• Endoscopic Sedation

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: March 9, 2018): 66
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: October 1, 2019
• Actual Primary Completion Date: October 1, 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03461718
• Other Study ID Numbers: 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

• Plan to Share IPD: No

• Responsible Party: Jerome Edelson, Brooke Army Medical Center
• Study Sponsor: Brooke Army Medical Center
• Collaborators: Not Provided

Investigators

• 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