Effect of esketamine on perioperative depressive symptoms in major surgery patients (PASSION II): study protocol for a randomised controlled trial.
Yang Zhou, Bo Ma, Wanchen Sun, Juan Wang, Yuxuan Fu, Anxin Wang, Gang Wang, Ruquan Han
BMJ Open April 26, 2022 DOI: 10.1136/bmjopen-2021-056713 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Randomized controlled trial protocol Placebo-controlled Double-blind Peer reviewed |
|---|---|
| Sample size | 564 |
| Population | Patients aged 18-65 years undergoing major surgery with moderate-to-severe depressive symptoms |
| Intervention | Esketamine |
| Dose | 0.2 mg/kg body weight |
| Duration | Single intraoperative dose; assessments at 3 days, 5 days, 1 month, 3 months and 6 months after surgery |
| Topics | Esketamine |
| Keywords | Depression symptoms Major surgery |
| Registration | NCT04425473 |
| Key findings | The protocol proposes testing whether a single intravenous dose of esketamine (0.2 mg/kg) at wound suturing improves depressive symptoms in patients undergoing major surgery, compared with placebo. The primary outcome is remission rate on the third postoperative day, with follow-up to six months; no results are reported. |
Abstract
Depressive symptoms are common for patients undergoing major surgery and may worsen their mental health and lead to poor clinical outcomes. It is essential to seek a safe rapid-acting treatment for relieving moderate-to-severe depressive symptoms in patients undergoing major surgery. This study is a randomised, placebo-controlled and double-blinded trial aiming to determine the effect of esketamine on moderate-to-severe depressive symptoms in patients undergoing major surgery. Five hundred and sixty-four participants, aged 18-65 years old, undergoing major surgery will be randomly allocated into the esketamine and placebo groups at a 1:1 ratio. Esketamine or placebo will be given intravenously at the same speed on suturing the incision by anaesthesiologists in charge who are blinded to the randomisation. In the esketamine group, the total dosage of esketamine will be 0.2 mg/kg body weight. To estimate the efficacy and safety endpoints, blinded evaluation by trained researchers will be completed at 3 days, 5 days, 1 month, 3 months and 6 months after surgery. The primary outcome is the remission rate at the third postoperative day. The secondary outcomes include depression-related scores, severe pain events and safety-related endpoints such as psychotic symptoms, manic symptoms and dissociative symptoms. This study was approved by the Institutional Review Board of Beijing Tiantan Hospital, Capital Medical University, Beijing, China on 30 October 2020 (KY-2020-058-02). This trial is designed to explore whether the administration of esketamine could improve the mental health of patients with depressive symptoms undergoing major surgery. The conclusions of this study will be published in peer-reviewed journals. NCT04425473.