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Administration and Dosage of KetaminePhase 2NCT03461718

Ketamine for Endoscopic Sedation in Outpatient Adult Endoscopy.

A Phase 2 study testing Ketamine, Midazolam injection and Fentanyl in people with Administration and Dosage of Ketamine and Endoscopic Sedation, run by Brooke Army Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
What is being tested?
Ketamine, Midazolam injection and Fentanyl
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
66 participants
Where
1 siteUnited States
Study dates
5 Mar 2018to 1 Oct 2019
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Patients age 18 to 65 years who present to the GI clinic for an EGD or colonoscopy

Who cannot join

  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Brooke Army Medical Center

    Fort Sam Houston, Texas, 78234

Other trials in United States

About this study

Official title: Ketamine as a Sedation Adjunct for Endoscopic Procedures

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.

Read the 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.

Being tested
Ketamine, Midazolam injection, Fentanyl

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • KetamineDrug

    Experimental arm for sedation.

  • Midazolam injectionDrug

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

  • FentanylDrug

    Part of standard sedation regimen

Study groups in NCT03461718
Study groupRoleWhat they receive
KetamineExperimentalGroup 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.
Receives: Drug: Ketamine; Drug: Midazolam injection
ControlActive comparatorThis group will receive midazolam and fentanyl alternated as currently preformed for endoscopy.
Receives: Drug: Midazolam injection; Drug: Fentanyl

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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: Measured within 15 minutes post proceudre

Secondary outcomes (8)

  1. Sedation time

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

    Measured: During the procedure

  2. Time to cecum (for colonoscopy)

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

    Measured: During the procedure

  3. Total dose of medications given

    All doses of medications will be summed and reported.

    Measured: During the procedure

  4. Overall procedure time

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

    Measured: During the procedure

  5. Adverse events

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

    Measured: During the procedure

  6. Changes in vital signs

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

    Measured: During the procedure

  7. Need for additional medications, ie reversal agents

    Will be measured as yes or no, specific dose and medication will be recorded for analysis.

    Measured: During the procedure

  8. 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.

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Mar 2018
  2. Study start5 Mar 2018
  3. Primary completion1 Oct 2019
  4. Study completion1 Oct 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
66 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03461718
Sponsor's protocol ID
C.2017.175
Status last verified
Jul 2020
First submitted
23 Feb 2018
Last updated
8 Jul 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Edelson JC, Edelson CV, Rockey DC, Morales AL, Chung KK, Robles MJ, Marowske JH, Patel AA, Edelson SFD, Subramanian SR, Gancayco JG. Randomized Controlled Trial of Ketamine and Moderate Sedation for Outpatient Endoscopy in Adults. Mil Med. 2024 Jan 23;189(1-2):313-320. doi: 10.1093/milmed/usac183.

    PubMed 35796486

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ketamine, Midazolam injection and Fentanyl in people with Administration and Dosage of Ketamine and Endoscopic Sedation, run by Brooke Army Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Provider satisfaction (time frame: Measured within 15 minutes post proceudre). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03461718, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2020.

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