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

Major Depressive Disorder Clinical Trial

Official title:

Double-blind Trial of Intraoperative Ketamine Versus Saline in Depressed Patients Undergoing Anesthesia for Non-cardiac Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03861988
• Other study ID #: 49114
• Status: Completed
• Phase: Phase 4
• Start date: August 22, 2019
• Est. completion date: September 27, 2022

Study information

• Verified date: October 2023
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: September 27, 2022
• Est. primary completion date: September 22, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patient presenting for non-cardiac, non-intracranial surgery

• Major Depressive Disorder

Exclusion Criteria:

• Pregnant of breastfeeding women

Related Conditions & MeSH terms

• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder
• Musculoskeletal Diseases
• Orthopedic Disorder
• Surgery

Intervention

Drug:
• Ketamine
0.5 mg/kg over 40 minutes, intravenous.
• Normal saline (placebo)
Normal saline infusion over 40 minutes, equivalent volume to ketamine infusion.

Locations

Country	Name	City	State
United States	Stanford University	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of Participants With Clinical Response	Clinical response defined as >=50% reduction in MADRS score from baseline. MADRS score range: 0 to 60, a lower score indicates lower severity of symptoms.	Post-intervention days 1, 2 and 3
Secondary	Number of Participants With Remission	Remission defined as a MADRS score of <=12 on day 14. MADRS score range: 0 to 60, a lower score indicates lower severity of symptoms.	Post-intervention day 14
Secondary	Hospital Anxiety and Depression Scale (HADS) Scale Score	This outcome measures self-reported symptoms of anxiety and depression on a scale that ranges from 0 to 42. A lower score indicates lower severity of symptoms.	Post-intervention days 1, 2, 3, 5, 7 and 14
Secondary	Cumulative Opioid Use	This outcome measures how many cumulative morphine-equivalents milligrams of opioid pain medication the patient has taken as an inpatient and after discharge from hospital	Post-intervention days 1, 2, 3, 5, 7 and 14
Secondary	Hospital Length of Stay	Number of days from admission (day of surgery) through discharge after surgery.	Average approximately 3 days post-intervention
Secondary	Brief Pain Inventory Pain Intensity Scale Score	Average pain intensity in the past 24 hours, rated on a numerical scale from 0 to 10 (with 0 representing "No pain" and 10 representing "Pain as bad as you can imagine").	Post-intervention days 1, 2, 3, 5, 7 and 14
Secondary	Brief Pain Inventory Pain Interference Scale Score	Pain interference in the past 24 hours, rated on a numerical scale from 0 to 10 (with 0 representing "Does not interfere" and 10 representing "Completely interferes").	Post-intervention days 1, 2, 3, 5, 7 and 14