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NCT Number: NCT03086148

Ketamine and Postoperative Depressive Symptom-PASSION

Perioperative depression symptom (PDS) is one of the common mental comorbidity, and influences the clinical outcomes and prognosis. However, there is no rapid acting treatment to deal with it during the limited hospital stay. This study aims to determine whether ketamine could improve the depressive symptom of peirioperative patients. It will also examine the safety for administrating ketamine as an antidepressant intraoperatively. Meanwhile, it will show if ketamine could improve anxiety, postoperative pain or delirium. This trial also will bring great concerns on patients with perioperative mental health and explore the measures to improve their psycho-related prognosis.

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Key information

Conditions

Ketamine; Depressive Symptom; Neurosurgery; Perioperative Period Behavior Behavioral Symptoms Depression

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Beijing TianTan Hospital

Beijing, 100070, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Brain tumor located supratentorial area and need to receive elective craniotomy;
  • Moderate to severe depressive symptom measured by the qualified psychiatric doctors.
  • Ages between 18 and 65 years old.
  • American Society of Anesthesiologists physical status I-III

Exclusion criteria

  • History of epilepsy;
  • Major depression disorder patients undergoing antidepressive therapy within 2 weeks; 3 Psychiatric illness; 4 Drug abuse; 5 History of allergy to the research drug; 6 Tumor located in the Wernick area, Broca area or the frontal pole; 7 Hyperthyroidism; 8 Patients can not cooperate with investigators on psychiatric assessments; 9 Pregnant or breast-feeding woman; 10 refuse to sign inform consent.

Treatment and study plan

ketamine

Drug

Ketamine will be administrated intravenously at dural opening, with the total dose of 0.5 mg/kg and continual infusion for 40 minutes.

Other names: Ketamine hydrochloride

normal saline

Drug

Normal saline will be administrated intravenously at dural opening, with the total dose of 0.5 ml/kg and continual infusion for 40 minutes.

Primary outcomes

  1. Response rate

    Time frame: Postoperative 3 days

    ≥50% reduction in MADRS scores from baseline value.The MADRS is a 10-item tool, with scores ranging from 0 to 60, and determining the severity of depression.

Secondary outcomes

  1. The remission rate

    Time frame: Postoperative 3 days and discharge.

    The remission rate is defined as the absolute value of MADRS no more than 10.

  2. Anxiety symptom

    Time frame: Postoperative 3 days.

    The anxious symptom is defined as HADS score no less than 11.

  3. Postoperative delirium

    Time frame: Postoperative 1 day.

    Postoperative delirium will be assessed by the Confusion Assessment Method for the Intensive Care Unit Scale (CAM-ICU) at 2 hours and 1 day after surgery.

  4. Severe pain

    Time frame: Postoperative 3 days.

    The incidence of severe pain within first postoperative three days, which is defined as mean and peak numerical rating scale (NRS) are higher than 5.

  5. Postoperative 30-day quality of life reported by KPS

    Time frame: Postoperative 30 days

    The quality of life will be evaluated by Karnofsky performance status (KPS) at postoperative 30 days.

  6. Psychiatric outcomes and complications

    Time frame: Postoperative 3 days and discharge.

    Postoperative complications include psychiatric symptoms evaluated by Brief Psychiatric Rating Scale (BPRS), manic symptoms assessed through the 11-item Young Mania Rating Scale (YMRS), and dissociative symptoms measured by the Clinician Administered Dissociative States Scale (CADSS). Moreover, postoperative complications also include aphasia, epilepsy, hemorrhage.

Sponsors and collaborators

Lead sponsor

Beijing Tiantan Hospital

Other

Registry information

Official study title

Effect of Low-dose Ketamine on Postoperative Depressive Symptom in Patients Undergoing Intracranial Tumor Resection (PASSION)

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Mar 22, 2017
Registry last updated
Jul 7, 2020

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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