Intraoperative Ketamine Versus Saline in Depressed Patients Undergoing Anesthesia for Non-cardiac Surgery
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03861988 |
Recruitment Status :
Completed
First Posted : March 5, 2019
Last Update Posted : September 28, 2022
|
Sponsor:
Stanford University
Information provided by (Responsible Party):
Boris D. Heifets, Stanford University
Tracking Information | |||||||
---|---|---|---|---|---|---|---|
First Submitted Date ICMJE | March 1, 2019 | ||||||
First Posted Date ICMJE | March 5, 2019 | ||||||
Last Update Posted Date | September 28, 2022 | ||||||
Actual Study Start Date ICMJE | August 22, 2019 | ||||||
Actual Primary Completion Date | September 22, 2022 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
score on Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: 1 to 3 days post procedure (up to 20 minutes to complete survey) ] This outcome measures symptoms of depression on a scales that ranges 0 to 60. A lower score indicates lower severity of symptoms. The assessment for this outcome measure will be taken once daily on days 1, 2 and 3 post procedure. A mixed model for repeated measures (MMRM) will be used to analyze the difference in postoperative MADRS score compared to pre-procedure.
|
||||||
Original Primary Outcome Measures ICMJE |
Composite score on Hospital Anxiety and Depression Scale (HADS) and Montgomery-Asberg Depression Rating Scales (MADRS) [ Time Frame: 1 to 5 days post procedure (up to 20 minutes to complete survey) ] This outcome measures a composite of the HADS and MADRS depression rating scales. The composite score range is 0 to 81. A lower score indicate lower severity of symptoms. The assessment for this outcome measure will be taken once between days 1 and 5 post procedure.
|
||||||
Change History | |||||||
Current Secondary Outcome Measures ICMJE |
Proportion of participants with clinical response (defined as >-50% reduction in MADRS score from baseline) [ Time Frame: 1 to 3 days post procedure (up to 20 minutes to complete survey) ] | ||||||
Original Secondary Outcome Measures ICMJE |
|
||||||
Current Other Pre-specified Outcome Measures |
|
||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | Intraoperative Ketamine Versus Saline in Depressed Patients Undergoing Anesthesia for Non-cardiac Surgery | ||||||
Official Title ICMJE | Double-blind Trial of Intraoperative Ketamine Versus Saline in Depressed Patients Undergoing Anesthesia for Non-cardiac Surgery | ||||||
Brief Summary | 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. | ||||||
Detailed Description | Major Depressive Disorder (MDD) is widely prevalent among patients preparing to have surgery, and is a known risk factor for complications after surgery, including wound infection, myocardial infarction and opioid use disorder. Ketamine has emerged as an effective, rapid-acting antidepressant therapy for patients with MDD, and may be a useful tool to prevent MDD-related morbidity in the perioperative period. Ketamine has been well studied for MDD in outpatient clinics where it is given as an infusion (0.5 mg/kg over 40 minutes) in awake patients. Ketamine is often used as part of an anesthetic cocktail in sedated or anesthetized patients, but it is unknown whether ketamine has an antidepressant effect in this context. The investigators will determine whether a ketamine infusion, compared to placebo (normal saline infusion), has an antidepressant effect when given during surgical anesthesia. If ketamine is an effective antidepressant in this population under anesthesia, its use could be incorporated into a set of interventions to minimize the perioperative complications associated with MDD. | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 4 | ||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Masking Description: Masking is for double blind phase only. Primary Purpose: Treatment
|
||||||
Condition ICMJE |
|
||||||
Intervention ICMJE |
|
||||||
Study Arms ICMJE |
|
||||||
Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||
Recruitment Information | |||||||
Recruitment Status ICMJE | Completed | ||||||
Actual Enrollment ICMJE |
45 | ||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||
Actual Study Completion Date ICMJE | September 27, 2022 | ||||||
Actual Primary Completion Date | September 22, 2022 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||||
Sex/Gender ICMJE |
|
||||||
Ages ICMJE | 18 Years to 80 Years (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | United States | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT03861988 | ||||||
Other Study ID Numbers ICMJE | 49114 | ||||||
Has Data Monitoring Committee | No | ||||||
U.S. FDA-regulated Product |
|
||||||
IPD Sharing Statement ICMJE |
|
||||||
Current Responsible Party | Boris D. Heifets, Stanford University | ||||||
Original Responsible Party | Same as current | ||||||
Current Study Sponsor ICMJE | Stanford University | ||||||
Original Study Sponsor ICMJE | Same as current | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
|
||||||
PRS Account | Stanford University | ||||||
Verification Date | September 2022 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |