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Clinical trial

Double-blind Trial of Intraoperative Ketamine Versus Saline in Depressed Patients Undergoing Anesthesia for Non-cardiac Surgery

ID
Name
49114
Description
This study evaluates whether ketamine, given as part of an anesthetic, improves depression symptoms in depressed patients undergoing non-cardiac surgery. Half of participants will receive a ketamine infusion during surgery, while the other half will receive a placebo (normal saline) during surgery.
Trial arms
Trial start
2019-08-22
Estimated PCD
2022-09-22
Trial end
2022-09-27
Status
Completed
Phase
Early phase I
Treatment
Ketamine
0.5 mg/kg over 40 minutes, intravenous.
Arms:
Double blind ketamine, Open label ketamine
Other names:
Ketalar.
Normal saline (placebo)
Normal saline infusion over 40 minutes, equivalent volume to ketamine infusion.
Arms:
Double blind placebo
Size
45
Primary endpoint
Montgomery-Asberg Depression Rating Scale (MADRS) Score
Post-intervention days 1, 2 and 3
Eligibility criteria
Inclusion Criteria: * Patient presenting for non-cardiac, non-intracranial surgery * Major Depressive Disorder Exclusion Criteria: * Pregnant of breastfeeding women
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'maskingDescription': 'Masking is for double blind phase only.', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 45, 'type': 'ACTUAL'}}
Updated at
2023-10-05

1 organization

1 product

1 drug

3 indications

Organization
Stanford University
Drug
Ketamine
Indication
Major Depressive Disorder
Indication
Surgery
Indication
Orthopedic Disorder
Product
Normal saline