NCT03086148

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jul 2017

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 16, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 22, 2017

Completed
4 months until next milestone

Study Start

First participant enrolled

July 5, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 24, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2018

Completed
Last Updated

July 7, 2020

Status Verified

July 1, 2020

Enrollment Period

1.1 years

First QC Date

March 16, 2017

Last Update Submit

July 2, 2020

Conditions

Ketamine; Depressive Symptom; Neurosurgery; Perioperative Period

Outcome Measures

Primary Outcomes (1)

  • 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.

    Postoperative 3 days

Secondary Outcomes (6)

  • The remission rate

    Postoperative 3 days and discharge.

  • Anxiety symptom

    Postoperative 3 days.

  • Postoperative delirium

    Postoperative 1 day.

  • Severe pain

    Postoperative 3 days.

  • Postoperative 30-day quality of life reported by KPS

    Postoperative 30 days

  • +1 more secondary outcomes

Study Arms (2)

ketamine group

EXPERIMENTAL
Drug: Ketamine

normal saline group

PLACEBO COMPARATOR
Drug: Normal saline

Interventions

KetamineDRUG

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

Also known as: Ketamine hydrochloride
ketamine group
Normal salineDRUG

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

normal saline group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing TianTan Hospital

Beijing, 100070, China

Location

Related Publications (2)

  • Zhou Y, Sun W, Zhang G, Wang A, Lin S, Chan MTV, Peng Y, Wang G, Han R. Ketamine Alleviates Depressive Symptoms in Patients Undergoing Intracranial Tumor Resection: A Randomized Controlled Trial. Anesth Analg. 2021 Dec 1;133(6):1588-1597. doi: 10.1213/ANE.0000000000005752.

    PMID: 34633992DERIVED

  • Zhou Y, Peng Y, Fang J, Sun W, Zhang G, Zhen L, Wang G, Han R. Effect of low-dose ketamine on PerioperAtive depreSsive Symptoms in patients undergoing Intracranial tumOr resectioN (PASSION): study protocol for a randomized controlled trial. Trials. 2018 Aug 29;19(1):463. doi: 10.1186/s13063-018-2831-0.

    PMID: 30157913DERIVED

MeSH Terms

Conditions

Depression

Interventions

KetamineSaline Solution

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

CyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Ruquan Han, M.D., Ph.D

    Department of Anesthesiology, Beijing Tiantan Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

March 16, 2017

First Posted

March 22, 2017

Study Start

July 5, 2017

Primary Completion

August 24, 2018

Study Completion

November 20, 2018

Last Updated

July 7, 2020

Record last verified: 2020-07

Locations

CN(1)