N/A N=85 Randomized Quadruple-blind Prevention

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

Blood Pressure

Bottom Line

View on ClinicalTrials.gov: NCT01065350 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2013

Primary outcome: Primary: Percent of Subjects With a Greater Than 20% Decrease in Systolic Blood Pressure (SBP) Following Induction of General Anesthesia — 48; 12; 67; 39 Percentage of subjects — p=<0.001

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Propofol (Drug); Ketamine (Drug)
Age: Adult · 18+ yrs
Sex: All
Sponsor: Mayo Clinic
Primary completion: Mar 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Percent of Subjects With a Greater Than 20% Decrease in Systolic Blood Pressure (SBP) Following Induction of General Anesthesia	48; 12; 67; 39; 76; 68	<0.001 sig
SECONDARY Percent of Subjects With a Greater Than 20% Decrease in Diastolic Blood Pressure (DBP) Following Induction of General Anesthesia	48; 17; 62; 41; 90; 78	<0.01 sig
SECONDARY Percent of Subjects With a Greater Than 20% Decrease in Mean Arterial Pressure (MAP) Following Induction of General Anesthesia	44; 10; 60; 35; 83; 75	<0.001 sig
SECONDARY Average Change in Cardiac Output (CO)	-0.8; -0.6; -1.0; -0.9	0.19
SECONDARY Average Change in Cardiac Index (CI)	-0.4; -0.3; -0.6; -0.5	0.26
SECONDARY Average Change in Heart Rate (HR)	-4.0; -4.6; -5.2; -7.0	0.61
SECONDARY Average Change in Systolic Blood Pressure (SBP)	-26.3; -12.5; -30.6; -21.8	<0.001 sig
SECONDARY Average Change in Diastolic Blood Pressure (DBP)	-15.9; -8.8; -19.3; -14.5	<0.01 sig
SECONDARY Average Change in Mean Arterial Pressure (MAP)	-18.7; -9.3; -22.6; -16.2	<0.001 sig
SECONDARY Average Change in Total Peripheral Resistance (TPR)	-261.2; -147.6; -321.7; -235.0	<0.01 sig
SECONDARY Average Change in Total Peripheral Resistance Index (TPRI)	-457.6; -275.0; -559.3; -430.6	0.017 sig
SECONDARY Average Change in Stroke Volume (SV)	-12.2; -7.8; -16.4; -11.6	0.029 sig
SECONDARY Average Change in Stroke Volume Index (SVI)	-6.8; -4.3; -9.2; -6.6	0.027 sig
SECONDARY Average Change in Stroke Volume Variation (SVV)	-2.2; -2.6; -2.6; -3.1	0.44

Summary

This is a pilot study to compare the hemodynamic changes that occur during induction with a novel drug combination known as ketofol (propofol and ketamine admixture with that of propofol alone (prototypic anesthesia induction agent). Propofol and ketamine are widely used as induction agents and their effects on patient hemodynamics are well known. Some of these drug-induced hemodynamic changes are undesirable and lead to deleterious effects on patient hemodynamics. We seek to investigate the hemodynamic changes associated with a novel drug combination known as ketofol (ketamine/propofol admixture) during induction and compare them to propofol. If we determine that the changes produced by ketofol are favorable compared with propofol, we then will seek to test its use in the trauma setting in a subsequent randomized controlled trial.

Eligibility Criteria

Inclusion Criteria

American Society of Anesthesiologists (ASA) physical status I and II who are to undergo elective general, urologic, orthopedic, plastic, or gynecologic surgery.

Exclusion Criteria

patients with age less than 18 yr or over 60 yr,
emergency surgery,
patients undergoing neurosurgical procedures,
any procedure with adjunctive analgesia,
any patient on chronic opiate use,
females who are known to be pregnant,
patients who had ingested psychotropic or sedative medication within one month of investigation,
patients with personality disorders,
weight greater than 20% of ideal, and
any known contraindications to ketamine or propofol.

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Data sourced from ClinicalTrials.gov (NCT01065350). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.