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

NCT03861988 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 49114
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder; Surgery; Orthopedic Disorder

Keywords

depression; ketamine; anesthesia; total joint arthroplasty

Outcome Measures

Primary Outcomes (1)

• Montgomery-Asberg Depression Rating Scale (MADRS) Score

  The MADRS is a 10-item scale for the evaluation of depressive symptoms (Montgomery et al 1979). Each MADRS item is rated on a 0 to 6 scale. Total score range from 0-60, where lower MADRS scores indicate lower levels of depressive symptoms. The assessment for this outcome will be taken once daily on days 1, 2 and 3 post procedure. A mixed model for repeated measures (MMRM) was used to analyze the difference in postoperative MADRS score between ketamine and placebo groups..

  Post-intervention days 1, 2 and 3

Secondary Outcomes (7)

• Number of Participants With Clinical Response

  Post-intervention days 1, 2 and 3

• Number of Participants With Remission

  Post-intervention day 14

• Hospital Anxiety and Depression Scale (HADS) Scale Score

  Post-intervention days 1, 2, 3, 5, 7 and 14

• Cumulative Opioid Use

  Post-intervention days 1, 2, 3, 5, 7 and 14

• Hospital Length of Stay

  Average approximately 3 days post-intervention

Study Arms (3)

Open label ketamine

EXPERIMENTAL

Patients will receive an intravenous ketamine infusion during surgery.

Drug: Ketamine

Double blind ketamine

EXPERIMENTAL

Patients will receive an intravenous ketamine infusion during surgery.

Drug: Ketamine

Double blind placebo

PLACEBO COMPARATOR

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

Drug: Normal saline (placebo)

Interventions

Ketamine DRUG

0.5 mg/kg over 40 minutes, intravenous.

Also known as: Ketalar.

Double blind ketamine; Open label ketamine

Normal saline (placebo) DRUG

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

Double blind placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Pregnant of breastfeeding women

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

Location

Related Publications (3)

• 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.

  PMID: 444788 BACKGROUND

• 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.

  PMID: 38188539 DERIVED

• 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.

  PMID: 37205558 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major; Musculoskeletal Diseases; Depression

Interventions

Ketamine; Saline Solution

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: Boris Heifets, MD, PhD
• Organization: Stanford University

bheifets@stanford.edu

(650) 497-8057

Study Officials

• Boris D Heifets, MD, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Masking is for double blind phase only.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Anesthesiology

Study Record Dates

• First Submitted: March 1, 2019
• First Posted: March 5, 2019
• Study Start: August 22, 2019
• Primary Completion: September 22, 2022
• Study Completion: September 27, 2022
• Last Updated: October 5, 2023
• Results First Posted: October 5, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)