Ketamine and Postoperative Depressive Symptom-PASSION

Phase 2

Completed

• Conditions: Ketamine; Depressive Symptom; Neurosurgery; Perioperative Period
• Interventions: Drug: Normal saline; Drug: Ketamine

• Registration Number: NCT03086148
• Lead Sponsor: Beijing Tiantan Hospital

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-03-16
• Study First Submitted QC: 2017-03-16
• Study First Posted: 2017-03-22
• Study Start: 2017-07-05
• Primary Completion: 2018-08-24
• Study Completion: 2018-11-20
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-02
• Last Update Posted: 2020-07-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
normal saline group	Normal saline	-
ketamine group	Ketamine	-

Primary Outcome Measures

Name	Time	Method
Response rate	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 Outcome Measures

Name	Time	Method
The remission rate	Postoperative 3 days and discharge.	The remission rate is defined as the absolute value of MADRS no more than 10.
Anxiety symptom	Postoperative 3 days.	The anxious symptom is defined as HADS score no less than 11.
Postoperative delirium	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.
Severe pain	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.
Postoperative 30-day quality of life reported by KPS	Postoperative 30 days	The quality of life will be evaluated by Karnofsky performance status (KPS) at postoperative 30 days.
Psychiatric outcomes and complications	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.

Trial Locations

Locations (1)

Beijing TianTan Hospital; 🇨🇳 Beijing, China