Phase 4
Completed N=45
Intraoperative Ketamine Versus Saline in Depressed Patients Undergoing Anesthesia for Non-cardiac Surgery
Major Depressive Disorder · Surgery · Orthopedic Disorder
Source: ClinicalTrials.gov NCT03861988 ↗
Enrolled (actual)
45
Serious AEs
6.7%
Results posted
Oct 2023
Primary outcomePrimary: Montgomery-Asberg Depression Rating Scale (MADRS) Score — 17.0; 12.7; 16.4; 25.4 score on a scale — p=0.13
◆ Published Evidence
Established
91citations · ~30 / year
Randomized trial of ketamine masked by surgical anesthesia in patients with depression.
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.
Linked Publications (2)
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Randomized trial of ketamine masked by surgical anesthesia in patients with depression.
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Randomized Trial of Ketamine Masked by Surgical Anesthesia in Depressed Patients.
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 | — |
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) and the linked publication. 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. Informational only — not medical advice.