MedDataX Logo

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

NCT ID: NCT03861988

Last Updated: 2023-10-05

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-22

Study Completion Date

2022-09-27

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Ketamine in the Treatment of Suicidal Depression

NCT01700829

Major Depressive Disorder Suicidal Ideation
COMPLETED PHASE4

Nitrous Oxide as Treatment for Major Depression - a Pilot Study

NCT02139540

Depression Major Depressive Disorder
COMPLETED PHASE2

Ketamine and Nitroprusside for Depression

NCT03102736

Depression
COMPLETED PHASE2

Efficacy of Deep Anaesthesia With Isoflurane as a Fast-response Antidepressant Agent

NCT04171193

Depressive Disorder, Major Treatment Resistant Depression Depressive Episode
UNKNOWN PHASE2

Ketamine-Assisted Mindfulness-Based Cognitive Therapy for Depression: A Pilot Study

NCT05950711

Major Depressive Disorder
ACTIVE_NOT_RECRUITING PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Major Depressive Disorder Surgery Orthopedic Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
Masking is for double blind phase only.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Open label ketamine

Patients will receive an intravenous ketamine infusion during surgery.

Group Type EXPERIMENTAL

Ketamine

Intervention Type DRUG

0.5 mg/kg over 40 minutes, intravenous.

Double blind ketamine

Patients will receive an intravenous ketamine infusion during surgery.

Group Type EXPERIMENTAL

Ketamine

Intervention Type DRUG

0.5 mg/kg over 40 minutes, intravenous.

Double blind placebo

Participants will receive placebo (normal saline infusion) during surgery.

Group Type PLACEBO_COMPARATOR

Normal saline (placebo)

Intervention Type DRUG

Normal saline infusion over 40 minutes, equivalent volume to ketamine infusion.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Ketamine

0.5 mg/kg over 40 minutes, intravenous.

Intervention Type DRUG

Normal saline (placebo)

Normal saline infusion over 40 minutes, equivalent volume to ketamine infusion.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Ketalar.

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patient presenting for non-cardiac, non-intracranial surgery
* Major Depressive Disorder

Exclusion Criteria

* Pregnant of breastfeeding women
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Stanford University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Boris D. Heifets

Assistant Professor of Anesthesiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Boris D Heifets, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Stanford University

Stanford, California, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

Montgomery SA, Asberg M. A new depression scale designed to be sensitive to change. Br J Psychiatry. 1979 Apr;134:382-9. doi: 10.1192/bjp.134.4.382.

Reference Type BACKGROUND
PMID: 444788 (View on PubMed)

Lii TR, Smith AE, Flohr JR, Okada RL, Nyongesa CA, Cianfichi LJ, Hack LM, Schatzberg AF, Heifets BD. Randomized trial of ketamine masked by surgical anesthesia in patients with depression. Nat Ment Health. 2023 Nov;1(11):876-886. doi: 10.1038/s44220-023-00140-x. Epub 2023 Oct 19.

Reference Type DERIVED
PMID: 38188539 (View on PubMed)

Lii TR, Smith AE, Flohr JR, Okada RL, Nyongesa CA, Cianfichi LJ, Hack LM, Schatzberg AF, Heifets BD. Randomized Trial of Ketamine Masked by Surgical Anesthesia in Depressed Patients. medRxiv [Preprint]. 2023 Jun 15:2023.04.28.23289210. doi: 10.1101/2023.04.28.23289210.

Reference Type DERIVED
PMID: 37205558 (View on PubMed)

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

49114

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

KET-RO Plus RO DBT for Treatment Resistant Depression
NCT06138691 COMPLETED PHASE1
Ketamine for Relapse Prevention in Recurrent Depressive Disorder
NCT02661061 TERMINATED PHASE1
Chronic Kidney Disease Antidepressant Sertraline Trial
NCT00946998 COMPLETED PHASE3
A Study of Sertraline to Prevent PTSD
NCT00182078 COMPLETED PHASE4
The Metabolic Effects of Antidepressants in Patients Diagnosed With Major Depressive Disorder
NCT01418638 UNKNOWN
Study Of Indiplon/Placebo With Sertraline In Insomnia Co-Existing With Depression
NCT00232167 TERMINATED PHASE3
Treatment of Post-Traumatic Brain Injury (TBI) Depression
NCT00233103 COMPLETED PHASE2
Combined Sertraline and Ketoprofen Administration in Major Depressive Disorder
NCT03514810 COMPLETED PHASE1
Antidepressant Controlled Trial for Negative Symptoms in Schizophrenia
NCT01032083 COMPLETED PHASE4
Treatment Resistant Depression (Pilot)
NCT01179009 COMPLETED NA
Combining Antidepressant Medication and Psychotherapy for Insomnia to Improve Depression Outcome
NCT00149825 COMPLETED PHASE2
Thyroid Medication and Antidepressants for Treating Major Depression
NCT00208702 COMPLETED PHASE4
Examining the Impact of Sirolimus on Ketamine's Antidepressant Effects
NCT02487485 COMPLETED PHASE2
A Study of Seltorexant as Adjunctive Therapy to Antidepressants in Adult and Elderly Participants With Major Depressive Disorder With Insomnia Symptoms Who Have Responded Inadequately to Antidepressant and Long-term Safety Extension Treatment With Seltorexant
NCT04533529 COMPLETED PHASE3
Evaluation of Stress Disorders
NCT00050804 COMPLETED PHASE4
Treatments for Psychogenic Nonepileptic Seizures (NES)
NCT00159965 COMPLETED PHASE4
A Study of Seltorexant as Adjunctive Therapy to Antidepressants in Adult and Elderly Participants With Major Depressive Disorder With Insomnia Symptoms Who Have Responded Inadequately to Antidepressant Therapy
NCT04532749 TERMINATED PHASE3
TC-5214 as add-on the Treatment of Major Depressive Disorder
NCT00692445 COMPLETED PHASE2
An Eight-week Study to Evaluate the Efficacy and Safety of Saredutant in Patients With Depression
NCT00250614 COMPLETED PHASE3
Treatment of Major Depression With St. John's Wort (Hypericum)
NCT00005013 COMPLETED NA
Chinese Herb for the Treatment of Depression and Anxiety Disorders
NCT03323697 UNKNOWN PHASE1/PHASE2
Sertraline vs. Placebo for Symptoms Following Traumatic Brain Injury
NCT00208585 UNKNOWN NA
Effects of Sertraline on Brain Connectivity in Adolescents With OCD
NCT02797808 COMPLETED PHASE1/PHASE2
A Retrospective And Multicenter Survey To Investigate The Dosage, Efficacy And Safety Of Sertraline In Posttraumatic Stress Disorder Patients
NCT01607593 COMPLETED
Drug Therapy to Treat Minor Depression
NCT00048815 COMPLETED NA