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Trial record 19 of 840 for:    Ketamine

Ketamine and Postoperative Depressive Symptom

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ClinicalTrials.gov Identifier: NCT03086148
Recruitment Status : Recruiting
First Posted : March 22, 2017
Last Update Posted : April 12, 2018
Sponsor:
Information provided by (Responsible Party):
Yuming Peng, 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.

Condition or disease Intervention/treatment Phase
Ketamine; Depressive Symptom; Neurosurgery; Perioperative Period Drug: Ketamine Drug: Normal saline Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Low-dose Ketamine on Postoperative Depressive Symptom in Patients Undergoing Intracranial Tumor Resection (PASSION)
Actual Study Start Date : July 5, 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : February 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Ketamine

Arm Intervention/treatment
Experimental: ketamine group 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

Placebo Comparator: normal saline group 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.




Primary Outcome Measures :
  1. Perioperative depression symptom (PDS) [ Time Frame: Postoperative 3 days ]
    The rate of response in treating PDS at postoperative 3 days, which is defined as more than relative 50% reduction from the baseline of 10-item MADRS score.


Secondary Outcome Measures :
  1. The remission rate of perioperative depression symptom (PDS) [ Time Frame: Postoperative 1 day, 2 days, 3 days, 5 days and 7 days. ]
    The remission rate is defined as the absolute value of MADRS no more than 10. MADRS will also be assessed at 1 day, 2 days, 5 days, and 7 days after the administration of ketamine.

  2. Perioperative anxiety symptom [ Time Frame: Postoperative 1 day, 2 days, 3 days, 5 days and 7 days. ]
    Perioperative anxiety symptom will be assessed by the hospital anxiety and depression scale. The anxious symptom is defined as HADS score no less than 11.

  3. Postoperative delirium [ Time Frame: Postoperative 2 hours, 1 day, 2 days, 3 days, 5 days and 7 days ]
    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.

  4. Severe pain [ Time Frame: Postoperative 1 day, 2 days, 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.

  5. Intra-operative awareness [ Time Frame: Postoperative 1 day ]
    Intra-operative awareness will be screened by the modified Brice questionnaire one day after surgery.

  6. Quality of life [ Time Frame: Postoperative 30 days ]
    The quality of life will be evaluated by Karnofsky performance status (KPS) at postoperative 30 days.

  7. Postoperative complications [ Time Frame: Postoperative 1 day, 2 days, 3 days, 5 days and 7 days. ]
    Postoperative complications includes 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 deep sedation, euphoria, hallucination, pathological dysphoria, nightmare, and sleeplessness.

  8. The Length of stay and the cost in ICU and hospital [ Time Frame: From the operation day to discharge from ICU and hospital. ]
    Record the length from the operation day to discharge from ICU and hospital.

  9. The plasmatic concentrations of ketamine, its metabolites and cytokines [ Time Frame: Pre-administration, 0 minutes, 110 minutes, 1 day and 3 days after ketamine administrated. ]
    The plasmatic concentrations of ketamine, its metabolites and cytokines (including BDNF, IL-6 and D-cycloserine) will be tested at different time points after ketamine administrated



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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. Hospital stay is expected to no less than 7 days.
  4. Ages between 18 and 65 years old

Exclusion Criteria:

  1. American Society of Anesthesiologists physical status Ⅳ-Ⅴ;
  2. History of epilepsy;
  3. Major depression disorder patients undergoing antidepressive therapy within 2 weeks;
  4. Psychiatric illness;
  5. Drug abuse;
  6. History of allergy to the research drug;
  7. Body mass index>30kg/m2;
  8. Heart rate >120 beats per minute;
  9. Systolic blood pressure>180mmHg;
  10. Heart failure;
  11. Renal or liver dysfunction;
  12. Tumor located in the Wernick area, Broca area or the frontal pole;
  13. Hyperthyroidism ;
  14. Patients can not cooperate with investigators on psychiatric assessments;
  15. Pregnant or breast-feeding woman;
  16. Patient refused to sign the consent inform.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03086148


Contacts
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Contact: Ruquan Han, M.D., Ph.D 8610-67096660 ruquan.han@gmail.com

Locations
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China
Beijing TianTan Hospital Recruiting
Beijing, China, 100050
Contact: Ruquan Han, M.D., Ph.D    8610-67096660    ruquan.han@gmail.com   
Sponsors and Collaborators
Beijing Tiantan Hospital
Investigators
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Study Chair: Ruquan Han, M.D., Ph.D Department of Anesthesiology, Beijing Tiantan Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Yuming Peng, Associate professor, Beijing Tiantan Hospital
ClinicalTrials.gov Identifier: NCT03086148     History of Changes
Other Study ID Numbers: 2017-03-16
First Posted: March 22, 2017    Key Record Dates
Last Update Posted: April 12, 2018
Last Verified: April 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Ketamine
Depression
Behavioral Symptoms
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action