Pain
Conditions
Keywords
Bispectral Index, Ketamine
Brief summary
The study question: Does the SNAP-Index (SI) correlates better with the OASS than the BIS Monitor during sedation with ketamine? The study hypothesis: Since the SNAP II monitor seems to be more responsive during emergence of anesthesia, it will have a better correlation with the OASS than the BIS monitor with the use of ketamine.
Interventions
DRUGKetamine group
ketamine bolus of 0.25mg/kg followed by an infusion set at 1.5 mcg /kg/min.
Sponsors
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
* Age : 18-64 years * ASA : I-III * Procedure : Breast or gynecological surgery * Anesthesia :Monitored anesthesia care
Exclusion criteria
* Pregnancy * Breast Feeding * Body Mass Index \>35kg/m2 * Drug or Alcohol abuse * Use anticonvulsants * History of CVA * Drop-out criteria: * Patient or surgeon request * Conversion to general anesthesia * Inability to obtain data from both monitors
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| TcCO2 Above 50 | Intraoperative, an average of about 1 and 1/2 hours. | % Time Tosca Monitor (TcCO2) above 50. A TcCo2 above 50 is indicative of hypoventilation. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ketamine Group ketamine bolus of 0.25mg/kg followed by an infusion set at 1.5 mcg /kg/min.
Ketamine group: ketamine bolus of 0.25mg/kg followed by an infusion set at 1.5 mcg /kg/min. | 9 |
| No Ketamine No ketamine added to anesthesia regimen | 16 |
| Total | 25 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | monitor data failure | 1 | 1 |
Baseline characteristics
| Characteristic | Ketamine Group | No Ketamine | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants | 16 Participants | 25 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 4 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 8 Participants | 11 Participants | 19 Participants |
| Region of Enrollment United States | 9 participants | 16 participants | 25 participants |
| Sex: Female, Male Female | 9 Participants | 16 Participants | 25 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 16 | 0 / 9 |
| serious Total, serious adverse events | 0 / 16 | 0 / 9 |
Outcome results
Primary
TcCO2 Above 50
% Time Tosca Monitor (TcCO2) above 50. A TcCo2 above 50 is indicative of hypoventilation.
Time frame: Intraoperative, an average of about 1 and 1/2 hours.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ketamine Group | TcCO2 Above 50 | 39 Percent time intraoperatrive | Standard Deviation 26.54 |
| No Ketamine | TcCO2 Above 50 | 30.8 Percent time intraoperatrive | Standard Deviation 26.14 |