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Completed

NCT Number: NCT04425473

Esketamine and Perioperative Depressive Symptoms

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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Key information

Conditions

Depressive Symptoms Behavior Behavioral Symptoms Depression Esketamine Major Surgery Perioperative Complication

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Beijing Tiantan Hospital, Capital Medical University

Beijing, 100070, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Esketamine

Drug

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

normal saline

Drug

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

Primary outcomes

  1. Depressive symptoms remission

    Time frame: Postoperative 3-day

    Remission is defined as the Montgomery-Åsberg Depression Rating Scale (MADRS) total score no more than 10, MADRS is a sensitive tool used for tracking improvement or progression in patients with major depressive disorder, consisting of 10 items that jointly assess the degree of depressive symptoms.

Secondary outcomes

  1. MADRS scores

    Time frame: Postoperative 3-day

    The differences in MADRS scores

  2. Depressive symptoms response

    Time frame: Postoperative 3-day

    The rates of patients achieving a response

  3. Moderate-to-severe pain

    Time frame: postoperative 3-day

    The rate of severe pain after surgery

  4. Side-effects and Adverse events

    Time frame: During surgery or up to 7 days after surgery

    All drug-related adverse events during surgery or before discharge

  5. Long-term patient outcome

    Time frame: 1, 3, and 6 months after surgery

    The long-term patient outcomes included depressive symptoms and disability as measured by the 12-item World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) at 1, 3, and 6 months after surgery.

Sponsors and collaborators

Lead sponsor

Beijing Tiantan Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Jun 11, 2020
Registry last updated
Aug 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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