Effects of Low Dose Ketamine Given at Induction of Anesthesia on Postoperative Mood in Patients With Depressive Symptoms
| Status: | Terminated |
|---|---|
| Conditions: | Depression, Depression, Major Depression Disorder (MDD) |
| Therapuetic Areas: | Psychiatry / Psychology, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 2/17/2018 |
| Start Date: | December 2015 |
| End Date: | September 2016 |
Ketamine has been shown to have an antidepressant effect when given intravenously in doses of
2mg/kg. Ketamine is used as a standard induction drug during general anesthesia. It is known
in this instance to decrease postoperative pain. No one has studied whether or not ketamine
when given in doses used during general anesthesia (0.5mg/kg intravenous) has an
antidepressant effect on surgical patients who suffer from depression. The study is designed
to determine whether or not a small dose of ketamine when given at the induction of
anesthesia could have an antidepressant effect on surgical patients with depression.
2mg/kg. Ketamine is used as a standard induction drug during general anesthesia. It is known
in this instance to decrease postoperative pain. No one has studied whether or not ketamine
when given in doses used during general anesthesia (0.5mg/kg intravenous) has an
antidepressant effect on surgical patients who suffer from depression. The study is designed
to determine whether or not a small dose of ketamine when given at the induction of
anesthesia could have an antidepressant effect on surgical patients with depression.
Non-pregnant females between the ages of 18-65 who are being admitted for gynecological
surgery will be given a bedside Goldberg depression screen as part of their routine
preanesthetic assessment. If the patient scores five or above on the Goldberg depression
screening, they will be asked if they would like to enroll in the study. Exclusion criteria
include uncontrolled hypertension, pregnancy, or allergy to ketamine.
Once the patient is consented they will be randomized to one of two groups. Every patient
will receive an antianxiety medication Midazolam and a narcotic fentanyl prior to going to
the operating room. Group A will receive ketamine 0.5mg/kg intravenous as part of their
induction for general anesthesia. Group B will not receive ketamine as part of their
anesthetic. All other induction drugs will be at the discretion of the anesthesiologist
performing the anesthetic.
The patients will be seen by a separate anesthesia provider (who is blinded to the group the
patient is in) and the results of the depression screening will be added to the patient's
data sheet.
The patients will be followed again one week after their surgery either in their hospital
room (if still hospitalized) or by phone. They will again be given the Goldberg Depression
screen and the data will again be added to their data sheet.
Several times during the study and at its conclusion the data will be matched with the
patients group in order to assess for adverse events such as suicidal ideations, nausea and
vomiting. If adverse events are noted, the study design will be altered to take into account
the adverse events.
surgery will be given a bedside Goldberg depression screen as part of their routine
preanesthetic assessment. If the patient scores five or above on the Goldberg depression
screening, they will be asked if they would like to enroll in the study. Exclusion criteria
include uncontrolled hypertension, pregnancy, or allergy to ketamine.
Once the patient is consented they will be randomized to one of two groups. Every patient
will receive an antianxiety medication Midazolam and a narcotic fentanyl prior to going to
the operating room. Group A will receive ketamine 0.5mg/kg intravenous as part of their
induction for general anesthesia. Group B will not receive ketamine as part of their
anesthetic. All other induction drugs will be at the discretion of the anesthesiologist
performing the anesthetic.
The patients will be seen by a separate anesthesia provider (who is blinded to the group the
patient is in) and the results of the depression screening will be added to the patient's
data sheet.
The patients will be followed again one week after their surgery either in their hospital
room (if still hospitalized) or by phone. They will again be given the Goldberg Depression
screen and the data will again be added to their data sheet.
Several times during the study and at its conclusion the data will be matched with the
patients group in order to assess for adverse events such as suicidal ideations, nausea and
vomiting. If adverse events are noted, the study design will be altered to take into account
the adverse events.
Inclusion Criteria:
- History of or current depression scoring five or above on Goldberg Depression Screen
Exclusion Criteria:
- Uncontrolled hypertension, allergy to ketamine,pregnancy
We found this trial at
1
site
Click here to add this to my saved trials
