CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 435 enrolled
Drug / intervention
Esketamine +1 moredrug
Likely dose
Esketamine 0.2mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04425473
NCT04425473Phase 3Completed

Effect of Esketamine on Perioperative Depressive Symptoms in Patients Undergoing Major Surgery

Beijing Tiantan Hospital·interventional·Posted Jun 11, 2020·Updated Aug 1, 2025

In Brief

A Phase 3 clinical trial evaluating Esketamine and Normal saline for Depressive Symptoms and 3 related conditions. Completed, enrolled 435 participants across 1 site.

Detailed Summary

Perioperative depressive symptoms (PDS) are common in population undergoing surgery, and this would be sharpened especially for complicated, high-risk major surgery. However, None of treatments could resolve this clinical problem during limited perioperative period. The remarkable effects of ketamine on treatment resistant depression have been verified by several clinical trials and the enantiomer S-ketamine (esketamine) showed similar antidepressant efficacy with better safety in recent studies. The efficacy and safety of esketamine administrated intra-operatively for PDS will be verified in this study. Other secondary outcomes such as anxiety, postoperative pain and psychiatric symptoms will also be investigated.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesChina
Collaborators--

Timeline

Phase 3CompletedFinished
202120222023202420252026
First PostedJun 11, 2020
Enrollment StartFeb 19, 2021
Primary CompletionJun 23, 2024
Study CompletionNov 27, 2024
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 6.1 years ago

Interventions

Esketaminedrug

Esketamine will be administrated intravenously when suturing incision, with total dose of 0.2mg/kg and continuous infusion for 40 minutes.

Normal salinedrug

Equivalent amount of normal saline will be administrated intravenously suturing incision.