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Ketamine and Propofol Combination Versus Propofol for Upper Gastrointestinal Endoscopy

This study is currently recruiting participants.
Verified September 2017 by Daniel Katz, Icahn School of Medicine at Mount Sinai
Sponsor:
ClinicalTrials.gov Identifier:
NCT02643979
First Posted: December 31, 2015
Last Update Posted: September 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Daniel Katz, Icahn School of Medicine at Mount Sinai
  Purpose
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.

Condition Intervention Phase
Obesity Bariatrics Sleep Apnea Syndromes Gastric Bypass Endoscopy Drug: Ketofol Drug: Propofol Drug: Saline Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Supportive Care
Official Title: Ketamine and Propofol Combination Versus Propofol for Upper Gastrointestinal Endoscopy

Resource links provided by NLM:


Further study details as provided by Daniel Katz, Icahn School of Medicine at Mount Sinai:

Primary Outcome Measures:
  • Incidence of gagging reaction [ Time Frame: Day 1 ]
    Incidence of gagging or "vomit-like" reaction on endoscopic insertion


Secondary Outcome Measures:
  • Incidence of airway obstruction [ Time Frame: Day 1 ]
    The Anesthesiologist caring for the patient during the upper endoscopy will make 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.

  • Total dose of Propofol used during the procedure [ Time Frame: Day 1 ]
    Propofol doses are logged in the computerized Compurecord system used in the operating room. Patients involved in the study will have their total Propofol dose required quantified and compared between groups who received Ketamine and groups who did not.

  • Mean Arterial Pressure [ Time Frame: Day 1 ]
  • Heart Rate [ Time Frame: Day 1 ]
  • Total sedation required to allow initiation of procedure [ Time Frame: Day 1 ]
    Using the computerized record system, the amount of Propofol a patient required to allow for the procedure to start will be quantified and compared between groups.

  • Incidence of Post-operative Nausea and/or Vomiting [ Time Frame: up to 6 months ]
  • Incidence of Emergence Delirium [ Time Frame: up to 6 months ]
    This will be measured from the procedure end until time of discharge. Will monitor time it takes for patient to be alert and oriented to time, person, and their location.

  • Time to Recovery [ Time Frame: up to 6 months ]
    This will be monitored via the electronic medical record system as the time between the anesthesia end time and when the patient is safe for discharge from the hospital.


Estimated Enrollment: 100
Study Start Date: December 2015
Estimated Study Completion Date: November 2019
Estimated Primary Completion Date: November 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ketofol and Propofol
This arm receives a 50mg dose of Ketamine mixed with 100mg of Propofol at the start of their upper endoscopy.
Drug: Ketofol
50mg of Ketamine mixed with 100mg of Propofol
Other Names:
  • Ketamine and Propofol
  • Ketalar
  • Diprivan
Drug: Propofol
100mg of Propofol
Other Name: Diprivan
Active Comparator: Propofol only
This arm receives 100mg of Propofol mixed with 1mL of saline at the start of the upper gastrointestinal endoscopy.
Drug: Propofol
100mg of Propofol
Other Name: Diprivan
Drug: Saline
1mL of saline

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • BMI > 30
  • Undergoing an upper gastrointestinal endoscopy

Exclusion Criteria:

  • 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02643979


Contacts
Contact: David A Maerz, MD 212-241-6500 David.Maerz@mountsinai.org
Contact: Daniel J Katz, MD 212-241-7473 Daniel.Katz@mountsinai.org

Locations
United States, New York
Icahn School of Medicine at Mount Sinai Recruiting
New York, New York, United States, 10029
Principal Investigator: Daniel J Katz, MD         
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
Investigators
Principal Investigator: Daniel J Katz, MD Icahn School of Medicine at Mount Sinai
Study Director: David A Maerz, MD Icahn School of Medicine at Mount Sinai
  More Information

Publications:
Responsible Party: Daniel Katz, Assistant Professor, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT02643979     History of Changes
Other Study ID Numbers: GCO 15-2139
First Submitted: December 22, 2015
First Posted: December 31, 2015
Last Update Posted: September 13, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Daniel Katz, Icahn School of Medicine at Mount Sinai:
Ketamine
Propofol
Ketofol
Obese
Upper gastrointestinal endoscopy
Sedation
Bariatric

Additional relevant MeSH terms:
Sleep Apnea Syndromes
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Propofol
Ketamine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Dissociative
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action