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When undergoing ECT treatments, patient recovery time and re-orientation time may be shorter using ketamine for induction than using methohexital.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ketamine First | Experimental | This arm will receive ketamine for induction first, followed by alternating treatments between methohexital and ketamine |
|
| Methohexital First | Experimental | This arm will receive Methohexital first for induction, followed by alternating treatments between ketamine and methohexital. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketamine | Drug | Ketamine (1.5mg/kg) will be given for induction, with room to titrate up to induction effect |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 hour |
| 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. | 1 hour |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tony Yen, MD | University of New Mexico | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of New Mexico | Albuquerque | New Mexico | 87131 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ketamine Then Methohexital (Alternating Each Trial) | This arm will receive ketamine for induction first, followed by alternating treatments between methohexital and ketamine. Each induction is counted as one trial. Each trial is followed by a day of no treatment (2 days for weekends). 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, with room to titrate up to induction effect |
| FG001 | Methohexital Then Ketamine (Alternating Each Trial) | This arm will receive Methohexital first for induction, followed by alternating treatments between ketamine and methohexital. Each induction is one trial. Each trial is followed by one day of no treatment (2 days for weekends). 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, with room to titrate up to induction effect |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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 | Posted | Mean | Standard Deviation | minutes | 1 hour |
|
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Due to the cross-over, the same participant experienced different adverse effects according to which medication they received for induction. Hence, the number of adverse events is reported per trial (each trial is one induction) instead of per participant. There was a total of 35 trials with ketamine, and 34 trials with methohexital.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ketamine Inductions | Number of trials receiving ketamine inductions. Each trial is one induction. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Tony Yen | University of NewMexico | 505-272-2610 | tyen@salud.unm.edu |
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| ID | Term |
|---|---|
| D000072458 | Orientation, Spatial |
| ID | Term |
|---|---|
| D013037 | Spatial Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D007649 | Ketamine |
| D008723 | Methohexital |
| ID | Term |
|---|---|
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
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| Methohexital | Drug | Methohexital (1.5mg/kg) will be given for induction |
|
| 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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Methohexital Inductions |
Patients receiving methohexital for inductions |
|
|
| 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. | Please see description from outcome 1 | Posted | Mean | Standard Deviation | minutes | 1 hour |
|
|
|
| 0 |
| 35 |
| 19 |
| 35 |
| EG001 | Methohexital Inductions | Number of trials receiving methohexital inductions. Each trial is one induction | 0 | 34 | 8 | 34 |
| Anxiety | Psychiatric disorders |
|
| Dysphoria | Psychiatric disorders |
|
| Headache | General disorders |
|
| Anesthesia Awareness | General disorders |
|
| Dizziness | General disorders |
|
| Agitation | Psychiatric disorders |
|
| Lethargy | General disorders |
|
| Hallucination | Psychiatric disorders |
|
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| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D001463 | Barbiturates |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |