Ketamine and Postoperative Depressive Symptom-PASSION

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-05

Study Completion Date

2018-11-20

Brief Summary

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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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Detailed Description

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Conditions

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Ketamine; Depressive Symptom; Neurosurgery; Perioperative Period

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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ketamine group

Group Type EXPERIMENTAL

Ketamine

Intervention Type DRUG

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

normal saline group

Group Type PLACEBO_COMPARATOR

Normal saline

Intervention Type 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.

Interventions

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Ketamine

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

Intervention Type DRUG

Normal saline

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

Intervention Type DRUG

Other Intervention Names

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Ketamine hydrochloride

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No