Esketamine and Perioperative Depressive Symptoms

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

435 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-19

Study Completion Date

2024-11-27

Brief Summary

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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.

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Detailed Description

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Conditions

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Depressive Symptoms Esketamine Perioperative Complication Major Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Esketamine

Group Type EXPERIMENTAL

Esketamine

Intervention Type DRUG

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

Placebo

Group Type PLACEBO_COMPARATOR

Normal saline

Intervention Type DRUG

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

Interventions

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Esketamine

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

Intervention Type DRUG

Normal saline

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patient undergoing elective major surgery
* Ages between 18 and 65 years old
* Moderate to severe depressive symptoms ( the Patient Health Questionnaire-9 scores equal to or more than 10 and Montgomery-Åsberg Depression Rating Scale scores equal to or more than 22 )
* Signed informed consent

Exclusion Criteria

* had aphasia or any conditions that prevented mental health assessments,
* had a history of psychotic or bipolar disorder,
* had a comorbidity that affected hormone levels,
* required prolonged postoperative mechanical ventilation,
* had received treatment with antidepressants within 2 weeks prior to the screening,
* had a body mass index greater than 30 kg/m2 and a Child-Pugh score greater than 6 points.
* had made repeated suicide attempts (as assessed by the 12-item Quick Inventory of Depressive Symptomatology scores less than 3),
* had experienced adverse reactions to ketamine or esketamine,
* had known drug use disorders,
* pregnant or breastfeeding

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No