Esketamine and Perioperative Depressive Symptoms

  • STATUS
    Recruiting
  • End date
    Dec 31, 2023
  • participants needed
    564
  • sponsor
    Beijing Tiantan Hospital
Updated on 11 March 2021

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.

Details
Condition Depression, Depression (Major/Severe), Depression (Adolescent), Depression (Pediatric), Depression (Adult and Geriatric), Depression (Treatment-Resistant), Major Surgery, Perioperative Complication, depressive symptoms, s-ketamine, esketamine
Treatment Normal saline, Esketamine
Clinical Study IdentifierNCT04425473
SponsorBeijing Tiantan Hospital
Last Modified on11 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 65 yrs?
Gender: Male or Female
Do you have any of these conditions: Depression (Treatment-Resistant) or Perioperative Complication or Major Surgery or depressive symptoms or Depression (Major/Severe) or Depression (Ped...?
Do you have any of these conditions: depressive symptoms or s-ketamine or esketamine or Depression (Adolescent) or Depression (Adult and Geriatric) or Perioperative Complication or Depres...?
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-sberg Depression Rating Scale scores equal to or more than 22 )
Signed informed consent

Exclusion Criteria

Patients combined with aphasia or other conditions leads that patients inability to cooperate with the metal assessments
Tumor related injury of the 9th, 10th, 11th, 12th cranial nerve or patients need keeping intubation after surgery
Medical history of psychotic or bipolar disorder
Laboratory evidence of hormone levels disorder due to primary diseases
Body Mass Index more than 30 kg
Child-Pugh grade B or C
Major depressive disorder with antidepressant therapy in the past 2 weeks before screening
History of adverse events to ketamine or esketamine
Patients with repeated suicide attempts (QIDS-SR 12-item more than or equal to 3)
History of drug abused
Pregnant or breastfeeding woman
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