We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Ketamine and Postoperative Depressive Symptom-PASSION

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03086148
Recruitment Status : Completed
First Posted : March 22, 2017
Last Update Posted : July 7, 2020
Sponsor:
Information provided by (Responsible Party):
Yuming Peng, Beijing Tiantan Hospital

Tracking Information
First Submitted Date  ICMJE March 16, 2017
First Posted Date  ICMJE March 22, 2017
Last Update Posted Date July 7, 2020
Actual Study Start Date  ICMJE July 5, 2017
Actual Primary Completion Date August 24, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 2, 2020)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: March 16, 2017)
Depression symptom [ Time Frame: Postoperative 3 days ]
Montgomery-Åsberg Depression Rating Scale will be used to assess the depression symptom.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 2, 2020)
  • 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.
  • Anxiety symptom [ Time Frame: Postoperative 3 days. ]
    The anxious symptom is defined as HADS score no less than 11.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ketamine and Postoperative Depressive Symptom-PASSION
Official Title  ICMJE Effect of Low-dose Ketamine on Postoperative Depressive Symptom in Patients Undergoing Intracranial Tumor Resection (PASSION)
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Ketamine; Depressive Symptom; Neurosurgery; Perioperative Period
Intervention  ICMJE
  • Drug: Ketamine
    Ketamine will be administrated intravenously at dural opening, with the total dose of 0.5 mg/kg and continual infusion for 40 minutes.
    Other Name: Ketamine hydrochloride
  • 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.
Study Arms  ICMJE
  • Experimental: ketamine group
    Intervention: Drug: Ketamine
  • Placebo Comparator: normal saline group
    Intervention: Drug: Normal saline
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 24, 2019)
84
Original Estimated Enrollment  ICMJE
 (submitted: March 16, 2017)
314
Actual Study Completion Date  ICMJE November 20, 2018
Actual Primary Completion Date August 24, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03086148
Other Study ID Numbers  ICMJE 2017-03-16
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Yuming Peng, Beijing Tiantan Hospital
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Beijing Tiantan Hospital
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Ruquan Han, M.D., Ph.D Department of Anesthesiology, Beijing Tiantan Hospital
PRS Account Beijing Tiantan Hospital
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP