Phase 4
N=45
Intraoperative Ketamine Versus Saline in Depressed Patients Undergoing Anesthesia for Non-cardiac Surgery
Major Depressive Disorder · Surgery · Orthopedic Disorder
Bottom Line
View on ClinicalTrials.gov: NCT03861988 ↗Enrolled (actual)
45
Serious AEs
6.7%
Results posted
Oct 2023
Primary outcome: Primary: Montgomery-Asberg Depression Rating Scale (MADRS) Score — 17.0; 12.7; 16.4; 25.4 score on a scale — p=0.13
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Ketamine (Drug); Normal saline (placebo) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Stanford University
- Primary completion
- Sep 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Montgomery-Asberg Depression Rating Scale (MADRS) Score |
17.0; 12.7; 16.4; 25.4; 15.1; 17.5 | 0.13 |
| SECONDARY Number of Participants With Clinical Response |
2; 12; 10; 1; 10; 12 | — |
| SECONDARY Number of Participants With Remission |
3; 8; 10 | — |
| SECONDARY Hospital Anxiety and Depression Scale (HADS) Scale Score |
14.8; 17.8; 19.9; 22.6; 18.8; 21.2 | — |
| SECONDARY Cumulative Opioid Use |
108.5; 60.9; 56.1; 249.3; 104.6; 107.7 | — |
| SECONDARY Hospital Length of Stay |
3.7; 1.9; 4.0 | — |
| SECONDARY Brief Pain Inventory Pain Intensity Scale Score |
4.6; 6.0; 5.2; 5.5; 5.3; 6.0 | — |
| SECONDARY Brief Pain Inventory Pain Interference Scale Score |
6.0; 8.1; 7.6; 6.3; 8.0; 8.1 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Patient presenting for non-cardiac, non-intracranial surgery
- Major Depressive Disorder
Exclusion Criteria
- Pregnant of breastfeeding women
Data sourced from ClinicalTrials.gov (NCT03861988). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.