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NMDA Receptor Antagonist

Intraoperative Ketamine Versus Saline in Depressed Patients Undergoing Anesthesia for Non-cardiac Surgery

Phase 4
Waitlist Available
Led By Boris D Heifets, MD, PhD
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up post-intervention days 1, 2, 3, 5, 7 and 14
Awards & highlights
Drug Has Already Been Approved
Pivotal Trial

Summary

This trial is testing whether ketamine can help relieve depression symptoms in people undergoing non-cardiac surgery.

Eligible Conditions
  • Depression
  • Surgery
  • Orthopedic Disorders

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~post-intervention days 1, 2, 3, 5, 7 and 14
This trial's timeline: 3 weeks for screening, Varies for treatment, and post-intervention days 1, 2, 3, 5, 7 and 14 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Montgomery-Asberg Depression Rating Scale (MADRS) Score
Secondary study objectives
Brief Pain Inventory Pain Intensity Scale Score
Brief Pain Inventory Pain Interference Scale Score
Cumulative Opioid Use
+4 more
Other study objectives
Hospital length of stay
Opioid consumption
Pain at surgical site: scale of 0-10
+4 more

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Open label ketamineExperimental Treatment1 Intervention
Patients will receive an intravenous ketamine infusion during surgery.
Group II: Double blind ketamineExperimental Treatment1 Intervention
Patients will receive an intravenous ketamine infusion during surgery.
Group III: Double blind placeboPlacebo Group1 Intervention
Participants will receive placebo (normal saline infusion) during surgery.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ketamine
2011
Completed Phase 4
~1120

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor
2,484 Previous Clinical Trials
17,516,049 Total Patients Enrolled
6 Trials studying Surgery
907 Patients Enrolled for Surgery
Boris D Heifets, MD, PhDPrincipal InvestigatorStanford University
1 Previous Clinical Trials
42 Total Patients Enrolled
~7 spots leftby Dec 2025
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