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ObesityPhase 4NCT02643979

Ketamine and Propofol Combination Versus Propofol for Upper Gastrointestinal Endoscopy

A Phase 4 study testing Ketofol, Propofol and Saline in people with Obesity and Bariatrics, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Obesity, Bariatrics, Sleep Apnea Syndromes
What is being tested?
Ketofol, Propofol and Saline
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
1 siteUnited States
Study dates
1 Jan 2016to 5 Jan 2019
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • BMI > 30
  • Undergoing an upper gastrointestinal endoscopy

Who cannot join

  • History of schizophrenia/schizoaffective disorder
  • History of bipolar disorder
  • History of dementia
  • Non-English Speaking
  • History of Glaucoma
  • Craniofacial Abnormalities
Show all 10Show fewer
  • Epilepsy
  • Allergy to Propofol
  • Allergy to Ketamine
  • Current known intracranial mass/lesion

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

Other trials in United States

About this study

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.

Read the detailed description

Upon patient arrival to endoscopy suite heart rate (HR), pre-procedure baseline blood pressure (BP), and pre-procedure oxygen saturation (SPO2) via pulse oximeter are recorded in endoscopy holding area, patient alertness and orientation assessed (respond to name, know the state, know the hospital, know the year, know the season).

Once the subject enters the endoscopy suite monitors are placed to record starting BP, HR, SPO2 recorded, nasal cannula with end tidal carbon dioxide (CO2) monitor attached, and 5-lead ECG.

Following time out patient given 100mg Lidocaine IV bolus, 1-minute delay, then study-provided syringe administered. Once patient assessed to produce an RSS score >5 (Asleep with sluggish response to glabellar tap or NO response) endoscopy proceeds.

Recorder (blinded) notes if initially provided syringe alone was enough to produce an RSS >5, notes subject's response to endoscopy insertion (presence or absence of gagging), notes amount of additional propofol required to maintain adequate conditions to continue endoscopy, records non-invasive blood pressure (NIBP) at 3-minute intervals, notes for level of airway obstruction (obstruction with continued air movement, obstruction requiring chin lift or jaw thrust for relief, obstruction requiring progression to assisted ventilation or intubation), notes for desaturation events (SPO2 <90% with a coherent waveform).

At the end of the procedure the total anesthesia time is recorded, total procedure start-to-finish time recorded, total dose of propofol recorded, and any incidence of patient agitation noted.

Once in recovery the recovery room admission HR, SPO2, NIBP recorded followed by admission +15 minutes HR, SPO2, and NIBP, any incidence of desaturation (<90% SPO2 with waveform) recorded, incidence of airway obstruction (with air movement, requiring airway maneuver, requiring intervention) recorded, time until patient is alert and oriented recorded (response to name, able to state what state they are in, able to state what hospital they are in, able to state the year, able to state the season), time-until-recovered recorded (Modified Aldrete Score > 9), incidence of nausea prior to recovery recorded, incidence of vomiting prior to recovery recorded, incidence of agitation or delirium prior to recovery recorded.

Being tested
Ketofol, Propofol, Saline
Keywords
Ketamine, Propofol, Ketofol, Obese, Upper gastrointestinal endoscopy, Sedation, Bariatric
Medical subject headings
Obesity, Sleep Apnea Syndromes

What participants receive

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

  • KetofolDrug

    Also called Ketamine and Propofol, Ketalar, Diprivan

    50mg of Ketamine mixed with 100mg of Propofol

  • PropofolDrug

    Also called Diprivan

    100mg of Propofol

  • SalineDrug

    1mL of saline

Study groups in NCT02643979
Study groupRoleWhat they receive
Ketofol and PropofolExperimentalThis arm receives a 50mg dose of Ketamine mixed with 100mg of Propofol at the start of their upper endoscopy.
Receives: Drug: Ketofol; Drug: Propofol
Propofol onlyActive comparatorThis arm receives 100mg of Propofol mixed with 1mL of saline at the start of the upper gastrointestinal endoscopy.
Receives: Drug: Propofol; Drug: Saline

What is being measured

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

  1. Number of Participants With Gagging Reaction

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

    Measured: Day 1

Secondary outcomes (6)

  1. Number of Participants With Any Type of Airway Obstruction

    The Anesthesiologist caring for the patient during the upper endoscopy made note of any obstructive events defined on a scale ranging from the patient audibly snoring (obstructing) to the patient obstructing and requiring assistance such as a chin lift or jaw thrust to relieve the obstruction and continue to move air adequately.

    Measured: Day 1

  2. Total Dose of Propofol Used During the Procedure

    Propofol doses are logged in the computerized Compurecord system used in the operating room. Patients involved in the study had their total Propofol dose required quantified and compared between groups who received Ketamine and groups who did not.

    Measured: Day 1

  3. Total Sedation Required to Allow Initiation of Procedure

    Using the computerized record system, the amount of Propofol a patient required to allow for the procedure to start quantified and compared between groups.

    Measured: Day 1

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

    Measured: up to 6 months

  5. Number of Participants With Emergence Delirium

    Number of participants with emergence delirium measured from the procedure end until time of discharge.

    Measured: Day 1

  6. Time to Recovery

    Monitored via the electronic medical record system as the time between the anesthesia end time and when the patient was safe for discharge from the hospital.

    Measured: Day 1

Timeline

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

  1. First posted31 Dec 2015 (estimated)
  2. Study start1 Jan 2016
  3. Primary completion5 Jan 2019
  4. Study completion5 Jan 2019

Why it stopped: Lack of Enrollment

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 4
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02643979
Sponsor's protocol ID
GCO 15-2139
Status last verified
Jan 2020
First submitted
22 Dec 2015
Last updated
11 Feb 2020
Data monitoring committee
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 25197112

  • 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.

    PubMed 24976998

  • 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.

    PubMed 24755240

  • 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.

    PubMed 18660398

  • 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.

    PubMed 22147144

  • 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.

    PubMed 18922416

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Ketofol, Propofol and Saline in people with Obesity and Bariatrics, run by Icahn School of Medicine at Mount Sinai 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 2 inclusion and 10 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: stopped early, as of the sponsor's last update on 11 Feb 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Participants With Gagging Reaction (time frame: Day 1). 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 NCT02643979, which also lists 6 linked publications.

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 11 Feb 2020.

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