Post-anesthesia Recovery, Orientation
Conditions
Keywords
orientation, post-anesthesia recovery, electroconvulsive therapy
Brief summary
When undergoing ECT treatments, patient recovery time and re-orientation time may be shorter using ketamine for induction than using methohexital.
Detailed description
ECT treatments are done under general anesthesia, and the induction is commonly done with methohexital. We will study whether using ketamine as an induction agent will result in a faster recovery time and quicker re-orientation time compared to using methohexital.
Interventions
DRUGKetamine
Ketamine (1.5mg/kg) will be given for induction, with room to titrate up to induction effect
DRUGMethohexital
Methohexital (1.5mg/kg) will be given for induction
Sponsors
University of New Mexico
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* All patients eligible for ECT with a primary mood disorder (bipolar disorder, major depressive disorder) will be eligible to participate in this study. - Patients must have decisional capacity and must be able to consent for this study.
Exclusion criteria
* patients with a primary psychotic disorder (schizophrenia, schizoaffective disorder); patients designated as having an American Society of Anesthesiologist (ASA) Status of greater than 3; * patients with a known allergic reactions to methohexital , ketamine and succinylcholine; * patients with current or previous history of aneurysms, intracranial bleeds, or intracranial hypertension; * patients with uncontrolled severe hypertension.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Re-orientation Time | 1 hour | Patients will be scored based on 5 questions (name, age, year, day of week, location). Each patient will be scored prior to induction as to how many questions they score correctly. Patient is deemed re-oriented when they score the same as baseline after the treatment. |
| Recovery Time | 1 hour | Recovery was assessed using 5 criteria (blood pressure, voluntary movement, oxygen requirement, consciousness, respiratory effort). Each criteria was scored from 0-2, with a full score of 10. The patient is scored at baseline, and is deemed recovered when all criteria has reached baseline score again. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ketamine First This arm will receive ketamine for induction first, followed by alternating treatments between methohexital and ketamine
Ketamine: Ketamine (1-1.5mg/kg) will be given for induction, with room to titrate up to induction effect
Methohexital: Methohexital (1-1.5mg/kg) will be given for induction | 8 |
| Methohexital First This arm will receive Methohexital first for induction, followed by alternating treatments between ketamine and methohexital.
Ketamine: Ketamine (1-1.5mg/kg) will be given for induction, with room to titrate up to induction effect
Methohexital: Methohexital (1-1.5mg/kg) will be given for induction | 12 |
| Total | 20 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | ECT discontinued | 1 | 1 |
| Overall Study | Withdrawal by Subject | 3 | 6 |
Baseline characteristics
| Characteristic | Ketamine First | Methohexital First | Total |
|---|---|---|---|
| Age, Continuous | 51.75 years STANDARD_DEVIATION 13.46 | 54 years STANDARD_DEVIATION 22.63 | 52.65 years STANDARD_DEVIATION 17.17 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 3 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 6 Participants | 8 Participants | 14 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 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 | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 8 Participants | 11 Participants | 19 Participants |
| Sex: Female, Male Female | 5 Participants | 7 Participants | 12 Participants |
| Sex: Female, Male Male | 3 Participants | 5 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 19 / 35 | 8 / 34 |
| serious Total, serious adverse events | 0 / 35 | 0 / 34 |
Outcome results
Primary
Recovery Time
Recovery was assessed using 5 criteria (blood pressure, voluntary movement, oxygen requirement, consciousness, respiratory effort). Each criteria was scored from 0-2, with a full score of 10. The patient is scored at baseline, and is deemed recovered when all criteria has reached baseline score again.
Time frame: 1 hour
Population: Please see description from outcome 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ketamine Inductions | Recovery Time | 28.6 minutes | Standard Deviation 2 |
| Methohexital Inductions | Recovery Time | 27.2 minutes | Standard Deviation 1.7 |
Primary
Re-orientation Time
Patients will be scored based on 5 questions (name, age, year, day of week, location). Each patient will be scored prior to induction as to how many questions they score correctly. Patient is deemed re-oriented when they score the same as baseline after the treatment.
Time frame: 1 hour
Population: Since this was a crossover study, all patients received both drugs, except for 2 patients who dropped out after receiving the first drug. For one of these patients the drug was ketamine, for the other the drug was methohexital. Number of total trials analyzed was 69, with 35 Ketamine trials and 34 Methohexital trials
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ketamine Inductions | Re-orientation Time | 24.5 minutes | Standard Deviation 1.6 |
| Methohexital Inductions | Re-orientation Time | 19.5 minutes | Standard Deviation 1.6 |