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Ketamine and Propofol Combination Versus Propofol for Upper Gastrointestinal Endoscopy

Ketamine and Propofol Combination Versus Propofol for Upper Gastrointestinal Endoscopy

Status
Terminated
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02643979
Enrollment
22
Registered
2015-12-31
Start date
2016-01-01
Completion date
2019-01-05
Last updated
2020-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Bariatrics, Sleep Apnea Syndromes, Gastric Bypass, Endoscopy

Keywords

Ketamine, Propofol, Ketofol, Obese, Upper gastrointestinal endoscopy, Sedation, Bariatric

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.

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.

Interventions

50mg of Ketamine mixed with 100mg of Propofol

DRUGPropofol

100mg of Propofol

DRUGSaline

1mL of saline

Sponsors

Icahn School of Medicine at Mount Sinai
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants With Gagging ReactionDay 1Number of participants with gagging or vomit-like reaction on endoscopic insertion

Secondary

MeasureTime frameDescription
Total Dose of Propofol Used During the ProcedureDay 1Propofol 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.
Total Sedation Required to Allow Initiation of ProcedureDay 1Using the computerized record system, the amount of Propofol a patient required to allow for the procedure to start quantified and compared between groups.
Number of Participants With Any Type of Airway ObstructionDay 1The 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.
Number of Participants With Emergence DeliriumDay 1Number of participants with emergence delirium measured from the procedure end until time of discharge.
Time to RecoveryDay 1Monitored 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.
Number of Participants With Post-operative Nausea and/or Vomitingup to 6 months

Countries

United States

Participant flow

Participants by arm

ArmCount
Ketofol: Ketamine and Propofol
This arm received a 50mg dose of Ketamine mixed with 100mg of Propofol at the start of their upper endoscopy.
11
Propofol Only
This arm received 100mg of Propofol mixed with 1mL of saline at the start of the upper gastrointestinal endoscopy.
11
Total22

Baseline characteristics

CharacteristicKetofol: Ketamine and PropofolPropofol OnlyTotal
Age, Continuous53.09 years
STANDARD_DEVIATION 16
44.63 years
STANDARD_DEVIATION 9.39
48.86 years
STANDARD_DEVIATION 13.7
ASA Class2.9 units on a scale
STANDARD_DEVIATION 0.2
3 units on a scale
STANDARD_DEVIATION 0
2.9 units on a scale
STANDARD_DEVIATION 0.2
Body Mass Index (BMI)41 kg/m^2
STANDARD_DEVIATION 5.4
44 kg/m^2
STANDARD_DEVIATION 8.3
42.5 kg/m^2
STANDARD_DEVIATION 7.2
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
3 Participants2 Participants5 Participants
Race (NIH/OMB)
Black or African American
2 Participants2 Participants4 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants0 Participants1 Participants
Race (NIH/OMB)
White
5 Participants7 Participants12 Participants
Sex: Female, Male
Female
8 Participants7 Participants15 Participants
Sex: Female, Male
Male
3 Participants4 Participants7 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 110 / 11
other
Total, other adverse events
0 / 110 / 11
serious
Total, serious adverse events
0 / 110 / 11

Outcome results

Primary

Number of Participants With Gagging Reaction

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

Time frame: Day 1

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Ketofol: Ketamine and PropofolNumber of Participants With Gagging Reaction2 Participants
Propofol OnlyNumber of Participants With Gagging Reaction1 Participants
Secondary

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.

Time frame: Day 1

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Ketofol: Ketamine and PropofolNumber of Participants With Any Type of Airway Obstruction4 Participants
Propofol OnlyNumber of Participants With Any Type of Airway Obstruction3 Participants
Secondary

Number of Participants With Emergence Delirium

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

Time frame: Day 1

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Ketofol: Ketamine and PropofolNumber of Participants With Emergence Delirium0 Participants
Propofol OnlyNumber of Participants With Emergence Delirium0 Participants
Secondary

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

Time frame: up to 6 months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Ketofol: Ketamine and PropofolNumber of Participants With Post-operative Nausea and/or Vomiting0 Participants
Propofol OnlyNumber of Participants With Post-operative Nausea and/or Vomiting0 Participants
Secondary

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.

Time frame: Day 1

ArmMeasureValue (MEAN)Dispersion
Ketofol: Ketamine and PropofolTime to Recovery21 minutesStandard Deviation 9
Propofol OnlyTime to Recovery25 minutesStandard Deviation 5
Secondary

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.

Time frame: Day 1

ArmMeasureValue (MEAN)Dispersion
Ketofol: Ketamine and PropofolTotal Dose of Propofol Used During the Procedure9.09 mg/kgStandard Deviation 19
Propofol OnlyTotal Dose of Propofol Used During the Procedure39 mg/kgStandard Deviation 57.3
Secondary

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.

Time frame: Day 1

ArmMeasureValue (MEAN)Dispersion
Ketofol: Ketamine and PropofolTotal Sedation Required to Allow Initiation of Procedure78 mg/kgStandard Deviation 50.6
Propofol OnlyTotal Sedation Required to Allow Initiation of Procedure61 mg/kgStandard Deviation 57.2

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026