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

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.

Timeline

Start

2019-08-22

Primary completion

2022-09-22

Completion

2022-09-27

Outcome

Missed primary endpoint

registry analysis (superiority test); Double Blind Ketamine vs Double Blind Placebo; p = 0.13; Mixed Models Analysis NCT03861988 ↗

paper A mixed-effects model showed no evidence of effect of treatment assignment on the primary outcome (-5.82, 95% CI -13.3 to 1.64, p=0.13). PMID 38188539 ↗

Publications

• Background 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.
• 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.
• 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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ketamine	Small molecule	0.5 mg/kg	Intravenous

Indications