Ketamine and Postoperative Depressive Symptom-PASSION

Beijing Tiantan Hospital84 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Ketamine; Depressive Symptom; Neurosurgery; Perioperative Period

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Brain tumor located supratentorial area and need to receive elective craniotomy; 2. Moderate to severe depressive symptom measured by the qualified psychiatric doctors. 3. Ages between 18 and 65 years old. 4. American Society of Anesthesiologists physical status I-III Exclusion Criteria: 1. History of epilepsy; 2. 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.

Outcomes

Primary Outcomes

Response rate

≥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.

Time frame: Postoperative 3 days

Secondary Outcomes

The remission rate

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

Time frame: Postoperative 3 days and discharge.

Anxiety symptom

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

Time frame: Postoperative 3 days.

Postoperative delirium

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.

Time frame: Postoperative 1 day.

Severe pain

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.

Time frame: Postoperative 3 days.

Postoperative 30-day quality of life reported by KPS

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

Time frame: Postoperative 30 days

Psychiatric outcomes and complications

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.