Ketamine Co-induction for Patients With Major Depressive Disorder
This proposed single-centre, double-blinded, randomized clinical trial of adult patients with depression presenting for gynaecologic surgery compares severity of depressive symptoms between patients receiving and not receiving ketamine as part of their general anaesthetic (n=50).
Detailed Description
Randomised, triple-masked, parallel-group trial comparing standard induction (propofol + fentanyl) versus induction with added ketamine hydrochloride 0.5 mg/kg in adults with major depressive disorder presenting for gynaecologic surgery.
Primary aim is to compare postoperative depressive symptom severity; secondary outcomes include safety/tolerability and perioperative physiological measures.
Study Arms & Interventions
Control
active comparatorPropofol and fentanyl as part of the patient's anaesthetic induction.
Interventions
- Placebovia IV• single dose
Propofol administered as part of anaesthetic induction.
- Placebovia IV• single dose
Fentanyl administered as part of anaesthetic induction.
Ketamine
experimentalPropofol and fentanyl plus ketamine hydrochloride (co‑induction) as part of the patient's anaesthetic induction.
Interventions
- Ketamine0.5 mg/kgvia IV• single dose
Ketamine hydrochloride 0.5 mg/kg added to induction.
- Placebovia IV• single dose
Propofol administered as part of anaesthetic induction.
- Placebovia IV• single dose
Fentanyl administered as part of anaesthetic induction.
Participants
Inclusion Criteria
- Inclusion Criteria:
- Diagnosis of major depressive disorder
- Presentation for gynecologic surgery requiring a general anesthetic
Exclusion Criteria
- Exclusion Criteria:
- Marked co-morbid cardiovascular disease
- Marked co-morbid respiratory disease
- History of intracranial hypertension
- History of seizures
- ASA Physical Status Classification IV or greater
- History of psychosis
- Current pregnancy
- Contraindication to ketamine administration