NCT02643979

Brief Summary

Propofol is one of the most popular anesthetic drugs used for sedation during upper gastrointestinal endoscopies due to its quick onset and quick resolution of symptoms allowing patients to leave the hospital sooner. However, when administered it can also slow the breathing of patients and cause others to have upper airway obstruction (such as snoring) which can impede proper spontaneous breathing. Ketamine is an agent that is capable of providing both pain control and sedation while having either minimal effect on breathing or promoting spontaneous breathing. Combining Ketamine with Propofol has the potential to reduce the total amount of Propofol used resulting in a procedure being performed under the same level of sedation but without the downside of reduced spontaneous breathing. Patients who are obese (defined as body mass index greater than 35) tend to be even more susceptible to this effect of Propofol. The researchers are investigating whether the addition of Ketamine will indeed allow for this continued comfortable level of sedation while promoting continued spontaneous breathing in obese patients undergoing upper gastrointestinal endoscopies.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for phase_4 obesity

Timeline
Completed

Started Jan 2016

Typical duration for phase_4 obesity

Geographic Reach
1 country

1 active site

Status
terminated

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

December 22, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 31, 2015

Completed
1 day until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 5, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 5, 2019

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

January 28, 2020

Completed
Last Updated

February 11, 2020

Status Verified

January 1, 2020

Enrollment Period

3 years

First QC Date

December 22, 2015

Results QC Date

January 17, 2020

Last Update Submit

January 28, 2020

Conditions

ObesityBariatricsSleep Apnea SyndromesGastric BypassEndoscopy

Keywords

KetaminePropofolKetofolObeseUpper gastrointestinal endoscopySedationBariatric

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Gagging Reaction

    Number of participants with gagging or "vomit-like" reaction on endoscopic insertion

    Day 1

Secondary Outcomes (6)

  • Number of Participants With Any Type of Airway Obstruction

    Day 1

  • Total Dose of Propofol Used During the Procedure

    Day 1

  • Total Sedation Required to Allow Initiation of Procedure

    Day 1

  • Number of Participants With Post-operative Nausea and/or Vomiting

    up to 6 months

  • Number of Participants With Emergence Delirium

    Day 1

  • +1 more secondary outcomes

Study Arms (2)

Ketofol and Propofol

EXPERIMENTAL

This arm receives a 50mg dose of Ketamine mixed with 100mg of Propofol at the start of their upper endoscopy.

Drug: KetofolDrug: Propofol

Propofol only

ACTIVE COMPARATOR

This arm receives 100mg of Propofol mixed with 1mL of saline at the start of the upper gastrointestinal endoscopy.

Drug: PropofolDrug: Saline

Interventions

KetofolDRUG

50mg of Ketamine mixed with 100mg of Propofol

Also known as: Ketamine and Propofol, Ketalar, Diprivan
Ketofol and Propofol
PropofolDRUG

100mg of Propofol

Also known as: Diprivan
Ketofol and PropofolPropofol only
SalineDRUG

1mL of saline

Propofol only

Eligibility Criteria

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

You may qualify if:

  • BMI \> 30
  • Undergoing an upper gastrointestinal endoscopy

You may not qualify if:

  • History of schizophrenia/schizoaffective disorder
  • History of bipolar disorder
  • History of dementia
  • Non-English Speaking
  • History of Glaucoma
  • Craniofacial Abnormalities
  • Epilepsy
  • Allergy to Propofol
  • Allergy to Ketamine
  • Current known intracranial mass/lesion

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Related Publications (6)

  • Tandon M, Pandey VK, Dubey GK, Pandey CK, Wadhwa N. Addition of sub-anaesthetic dose of ketamine reduces gag reflex during propofol based sedation for upper gastrointestinal endoscopy: A prospective randomised double-blind study. Indian J Anaesth. 2014 Jul;58(4):436-41. doi: 10.4103/0019-5049.138981.

    PMID: 25197112BACKGROUND

  • Dal T, Sazak H, Tunc M, Sahin S, Yilmaz A. A comparison of ketamine-midazolam and ketamine-propofol combinations used for sedation in the endobronchial ultrasound-guided transbronchial needle aspiration: a prospective, single-blind, randomized study. J Thorac Dis. 2014 Jun;6(6):742-51. doi: 10.3978/j.issn.2072-1439.2014.04.10.

    PMID: 24976998BACKGROUND

  • Street MH, Gerard JM. A fixed-dose ketamine protocol for adolescent sedations in a pediatric emergency department. J Pediatr. 2014 Sep;165(3):453-8. doi: 10.1016/j.jpeds.2014.03.021. Epub 2014 Apr 20.

    PMID: 24755240BACKGROUND

  • Newton A, Fitton L. Intravenous ketamine for adult procedural sedation in the emergency department: a prospective cohort study. Emerg Med J. 2008 Aug;25(8):498-501. doi: 10.1136/emj.2007.053421.

    PMID: 18660398BACKGROUND

  • Sih K, Campbell SG, Tallon JM, Magee K, Zed PJ. Ketamine in adult emergency medicine: controversies and recent advances. Ann Pharmacother. 2011 Dec;45(12):1525-34. doi: 10.1345/aph.1Q370. Epub 2011 Dec 6.

    PMID: 22147144BACKGROUND

  • Pambianco DJ. Future directions in endoscopic sedation. Gastrointest Endosc Clin N Am. 2008 Oct;18(4):789-99, x. doi: 10.1016/j.giec.2008.06.004.

    PMID: 18922416BACKGROUND

MeSH Terms

Conditions

ObesitySleep Apnea Syndromes

Interventions

KetaminePropofolSodium Chloride

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Intervention Hierarchy (Ancestors)

CyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPhenolsBenzene DerivativesHydrocarbons, AromaticChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Results Point of Contact

Title
Dr. Daniel Katz
Organization
Icahn School of Medicine at Mount Sinai
daniel.katz@mountsinai.org
212-241-7475

Study Officials

  • Daniel J Katz, MD

    Icahn School of Medicine at Mount Sinai

    PRINCIPAL INVESTIGATOR

  • David A Maerz, MD

    Icahn School of Medicine at Mount Sinai

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

December 22, 2015

First Posted

December 31, 2015

Study Start

January 1, 2016

Primary Completion

January 5, 2019

Study Completion

January 5, 2019

Last Updated

February 11, 2020

Results First Posted

January 28, 2020

Record last verified: 2020-01

Locations

US(1)