NCT03461718

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Mar 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 23, 2018

Completed
10 days until next milestone

Study Start

First participant enrolled

March 5, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 12, 2018

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2019

Completed
Last Updated

July 8, 2020

Status Verified

July 1, 2020

Enrollment Period

1.6 years

First QC Date

February 23, 2018

Last Update Submit

July 7, 2020

Conditions

Administration and Dosage of KetamineEndoscopic Sedation

Outcome Measures

Primary Outcomes (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 within 15 minutes post proceudre

Secondary Outcomes (8)

  • Sedation time

    During the procedure

  • Time to cecum (for colonoscopy)

    During the procedure

  • Total dose of medications given

    During the procedure

  • Overall procedure time

    During the procedure

  • Adverse events

    During the procedure

  • +3 more secondary outcomes

Study Arms (2)

Ketamine

EXPERIMENTAL

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.

Drug: KetamineDrug: Midazolam injection

Control

ACTIVE COMPARATOR

This group will receive midazolam and fentanyl alternated as currently preformed for endoscopy.

Drug: Midazolam injectionDrug: Fentanyl

Interventions

KetamineDRUG

Experimental arm for sedation.

Ketamine
Midazolam injectionDRUG

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

ControlKetamine
FentanylDRUG

Part of standard sedation regimen

Control

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brooke Army Medical Center

Fort Sam Houston, Texas, 78234, United States

Location

Related Publications (1)

  • 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.

    PMID: 35796486DERIVED

MeSH Terms

Interventions

KetamineMidazolamFentanyl

Intervention Hierarchy (Ancestors)

CyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsBenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsPiperidinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Jerome C Edelson, MD

    BAMC

    PRINCIPAL INVESTIGATOR

  • John G Gancayco, MD

    BAMC

    STUDY CHAIR

  • Cyrus V Edelson, MD

    BAMC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physician

Study Record Dates

First Submitted

February 23, 2018

First Posted

March 12, 2018

Study Start

March 5, 2018

Primary Completion

October 1, 2019

Study Completion

October 1, 2019

Last Updated

July 8, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)