Trial Outcomes & Findings for A Comparison of Ketofol (Ketamine and Propofol Admixture) Versus Propofol as Induction Agents on Hemodynamic Parameters (NCT NCT01065350)

Results Overview

Blood pressure was recorded every minute for a total of 30 minutes after anesthesia was induced and readings were captured via a Non-Invasive Cardiac Output Monitor \[NICOM\], Cheetah Medical, Israel. The percentage of subjects experiencing decreases in SBP of greater than 20% during the specified time intervals is reported, as compared to the baseline systolic blood pressure reading. There are two numbers in a blood pressure reading, and they are expressed in millimeters of mercury (mm Hg). This tells how high in millimeters the pressure of your blood raises a column of mercury. The numbers usually are expressed in the form of a fraction; an example of a blood pressure reading is 120/80 mm Hg. The first, or top, number (120 in the example) is the systolic pressure. The systolic pressure is the measure of your blood pressure as the heart contracts and pumps blood.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

85 participants

Primary outcome timeframe

Baseline, 5 minutes, 10 minutes, 30 minutes post induction

Results posted on

2013-05-03

Participant Flow

Patients requiring surgical procedures with general anesthesia were recruited and enrolled at Dartmouth-Hitchcock Medical Center in Lebanon, New Hampshire from December 2010 to March 2011.

Participant milestones

Participant milestones
Measure	Propofol As part of the induction, patients will be given 2 milligrams of propofol per kilogram (mg/kg) of body weight. The clinician will receive a 20 milliliter (mL) syringe of propofol. If the dose, 2 mg/kg, does not add up to a total of 20 mL, normal saline will be added to make up for the 20 mL.	Ketofol As part of the induction, patients will be given 20 mL syringe of an admixture called "ketofol," which combines ketamine and propofol in one syringe. The dose is weight-based such that ketamine will represent 0.75 mg/kg of the dose and propofol, 1.5 mg/kg of the dose.
Overall Study STARTED	43	42
Overall Study COMPLETED	43	41
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Propofol As part of the induction, patients will be given 2 milligrams of propofol per kilogram (mg/kg) of body weight. The clinician will receive a 20 milliliter (mL) syringe of propofol. If the dose, 2 mg/kg, does not add up to a total of 20 mL, normal saline will be added to make up for the 20 mL.	Ketofol As part of the induction, patients will be given 20 mL syringe of an admixture called "ketofol," which combines ketamine and propofol in one syringe. The dose is weight-based such that ketamine will represent 0.75 mg/kg of the dose and propofol, 1.5 mg/kg of the dose.
Overall Study Received incorrect drug allocation	0	1

Baseline Characteristics

A Comparison of Ketofol (Ketamine and Propofol Admixture) Versus Propofol as Induction Agents on Hemodynamic Parameters

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Propofol n=43 Participants As part of the induction, patients will be given 2 milligrams of propofol per kilogram (mg/kg) of body weight. The clinician will receive a 20 milliliter (mL) syringe of propofol. If the dose, 2 mg/kg, does not add up to a total of 20 mL, normal saline will be added to make up for the 20 mL.	Ketofol n=41 Participants As part of the induction, patients will be given 20 mL syringe of an admixture called "ketofol," which combines ketamine and propofol in one syringe. The dose is weight-based such that ketamine will represent 0.75 mg/kg of the dose and propofol, 1.5 mg/kg of the dose. One subject in the ketofol group was excluded from analysis due to incorrect study drug assignment and outside the protocol-specified dose.	Total n=84 Participants Total of all reporting groups
Age Continuous	43 years STANDARD_DEVIATION 11 • n=5 Participants	42 years STANDARD_DEVIATION 12 • n=7 Participants	42.68 years STANDARD_DEVIATION 11.51 • n=5 Participants
Sex: Female, Male Female	28 Participants n=5 Participants	27 Participants n=7 Participants	55 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	14 Participants n=7 Participants	29 Participants n=5 Participants
Region of Enrollment United States	43 participants n=5 Participants	41 participants n=7 Participants	84 participants n=5 Participants
Body Weight	69.2 kilograms STANDARD_DEVIATION 11.7 • n=5 Participants	68.9 kilograms STANDARD_DEVIATION 11.2 • n=7 Participants	68.97 kilograms STANDARD_DEVIATION 11.41 • n=5 Participants
Body Height	169.9 centimeters STANDARD_DEVIATION 9.1 • n=5 Participants	168.9 centimeters STANDARD_DEVIATION 9.2 • n=7 Participants	169.40 centimeters STANDARD_DEVIATION 9.03 • n=5 Participants
Systolic Blood Pressure	125 millimeters of mercury (mm Hg) STANDARD_DEVIATION 17 • n=5 Participants	122 millimeters of mercury (mm Hg) STANDARD_DEVIATION 15 • n=7 Participants	124.19 millimeters of mercury (mm Hg) STANDARD_DEVIATION 16.41 • n=5 Participants
Diastolic Blood Pressure	76 millimeters of mercury (mm Hg) STANDARD_DEVIATION 12 • n=5 Participants	76 millimeters of mercury (mm Hg) STANDARD_DEVIATION 10 • n=7 Participants	76 millimeters of mercury (mm Hg) STANDARD_DEVIATION 11 • n=5 Participants
Heart Rate	72 beats per minute STANDARD_DEVIATION 16 • n=5 Participants	73 beats per minute STANDARD_DEVIATION 14 • n=7 Participants	73 beats per minute STANDARD_DEVIATION 15 • n=5 Participants
American Society of Anesthesiology (ASA) Physical Status ASA Status 1	21 Participants n=5 Participants	14 Participants n=7 Participants	35 Participants n=5 Participants
American Society of Anesthesiology (ASA) Physical Status ASA Status 2	22 Participants n=5 Participants	27 Participants n=7 Participants	49 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 5 minutes, 10 minutes, 30 minutes post induction

Population: 85 patients were enrolled (43 Propofol/42 Ketofol). However, one subject randomized to the ketofol group received the wrong study drug and in a larger dose than indicated in protocol. This subject was excluded from the analysis and baseline measures.

Blood pressure was recorded every minute for a total of 30 minutes after anesthesia was induced and readings were captured via a Non-Invasive Cardiac Output Monitor \[NICOM\], Cheetah Medical, Israel. The percentage of subjects experiencing decreases in SBP of greater than 20% during the specified time intervals is reported, as compared to the baseline systolic blood pressure reading. There are two numbers in a blood pressure reading, and they are expressed in millimeters of mercury (mm Hg). This tells how high in millimeters the pressure of your blood raises a column of mercury. The numbers usually are expressed in the form of a fraction; an example of a blood pressure reading is 120/80 mm Hg. The first, or top, number (120 in the example) is the systolic pressure. The systolic pressure is the measure of your blood pressure as the heart contracts and pumps blood.

Outcome measures

Outcome measures
Measure	Propofol n=43 Participants As part of the induction, patients will be given 2 milligrams of propofol per kilogram (mg/kg) of body weight. The clinician will receive a 20 milliliter (mL) syringe of propofol. If the dose, 2 mg/kg, does not add up to a total of 20 mL, normal saline will be added to make up for the 20 mL.	Ketofol n=41 Participants As part of the induction, patients will be given 20 mL syringe of an admixture called "ketofol," which combines ketamine and propofol in one syringe. The dose is weight-based such that ketamine will represent 0.75 mg/kg of the dose and propofol, 1.5 mg/kg of the dose.
Percent of Subjects With a Greater Than 20% Decrease in Systolic Blood Pressure (SBP) Following Induction of General Anesthesia SBP baseline to 5 minutes	48 Percentage of subjects Interval 2.07 to 26.15	12 Percentage of subjects
Percent of Subjects With a Greater Than 20% Decrease in Systolic Blood Pressure (SBP) Following Induction of General Anesthesia SBP baseline to 10 minutes	67 Percentage of subjects	39 Percentage of subjects
Percent of Subjects With a Greater Than 20% Decrease in Systolic Blood Pressure (SBP) Following Induction of General Anesthesia SBP baseline to 30 minutes	76 Percentage of subjects	68 Percentage of subjects

SECONDARY outcome

Timeframe: Baseline, 5 minutes, 10 minutes, 30 minutes post induction

Population: 85 patients were enrolled (43 Propofol/42 Ketofol). However, one subject randomized to the ketofol group received the wrong study drug and in a larger dose than indicated in protocol. This subject was excluded from the analysis and baseline measures.

Blood pressure was recorded every minute for a total of 30 minutes after anesthesia was induced and readings were captured via a Non-Invasive Cardiac Output Monitor \[NICOM\], Cheetah Medical, Israel. The percentage of subjects experiencing decreases in DBP of greater than 20% during the specified time intervals is reported, as compared to the baseline DBP reading. The second or lower number of a blood pressure reading is the DBP and is the measure taken when your heart is at rest.

Outcome measures

Outcome measures
Measure	Propofol n=43 Participants As part of the induction, patients will be given 2 milligrams of propofol per kilogram (mg/kg) of body weight. The clinician will receive a 20 milliliter (mL) syringe of propofol. If the dose, 2 mg/kg, does not add up to a total of 20 mL, normal saline will be added to make up for the 20 mL.	Ketofol n=41 Participants As part of the induction, patients will be given 20 mL syringe of an admixture called "ketofol," which combines ketamine and propofol in one syringe. The dose is weight-based such that ketamine will represent 0.75 mg/kg of the dose and propofol, 1.5 mg/kg of the dose.
Percent of Subjects With a Greater Than 20% Decrease in Diastolic Blood Pressure (DBP) Following Induction of General Anesthesia DBP baseline to 5 minutes	48 Percentage of subjects	17 Percentage of subjects
Percent of Subjects With a Greater Than 20% Decrease in Diastolic Blood Pressure (DBP) Following Induction of General Anesthesia DBP baseline to 10 minutes	62 Percentage of subjects	41 Percentage of subjects
Percent of Subjects With a Greater Than 20% Decrease in Diastolic Blood Pressure (DBP) Following Induction of General Anesthesia DBP baseline to 30 minutes	90 Percentage of subjects	78 Percentage of subjects

SECONDARY outcome

Timeframe: Baseline, 5 minutes, 10 minutes, 30 minutes post induction

Population: 85 patients were enrolled (43 Propofol/42 Ketofol). However, one subject randomized to the ketofol group received the wrong study drug and in a larger dose than indicated in protocol. This subject was excluded from the analysis and baseline measures.

MAP was recorded every minute for a total of 30 minutes after anesthesia was induced and readings were captured via a Non-Invasive Cardiac Output Monitor \[NICOM\], Cheetah Medical, Israel. The percentage of subjects experiencing decreases in MAP of greater than 20% during the specified time intervals is reported, as compared to the baseline MAP reading.