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Completed

NCT Number: NCT03461718

Ketamine for Endoscopic Sedation in Outpatient Adult Endoscopy.

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.

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Key information

Conditions

Administration and Dosage of Ketamine Endoscopic Sedation

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Brooke Army Medical Center

Fort Sam Houston, Texas, 78234, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ketamine

Drug

Experimental arm for sedation.

Midazolam injection

Drug

Part of standard sedation regimen and anxiolysis and for minimization of emergence reaction

Fentanyl

Drug

Part of standard sedation regimen

Primary outcomes

  1. 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).

Secondary outcomes

  1. Sedation time

    Time frame: During the procedure

    Time from sedation administration until procedure start, will be measured in minutes

  2. Time to cecum (for colonoscopy)

    Time frame: During the procedure

    Time required for endoscopist to reach the cecum, will be measured in minutes

  3. Total dose of medications given

    Time frame: During the procedure

    All doses of medications will be summed and reported.

  4. Overall procedure time

    Time frame: During the procedure

    The time from procedure start to procedure completion will be measured in minutes

  5. Adverse events

    Time frame: During the procedure

    Are detailed in the protocol. We will be recording the presence or absence of adverse events.

  6. Changes in vital signs

    Time frame: During the procedure

    As defined in the protocol. We will be recording all vital signs for later analysis.

  7. 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.

  8. 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.

Sponsors and collaborators

Lead sponsor

Brooke Army Medical Center

Fed

Registry information

Official study title

Ketamine as a Sedation Adjunct for Endoscopic Procedures

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Mar 12, 2018
Registry last updated
Jul 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.