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
|Condition or disease||Intervention/treatment||Phase|
|Ketamine; Depressive Symptom; Neurosurgery; Perioperative Period||Drug: Ketamine Drug: Normal saline||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Experimental: ketamine group||
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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Intra-operative awareness [ Time Frame: Postoperative 1 day ]Intra-operative awareness will be screened by the modified Brice questionnaire one day after surgery.
- Quality of life [ Time Frame: Postoperative 30 days ]The quality of life will be evaluated by Karnofsky performance status (KPS) at postoperative 30 days.
- 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.
- 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.
- 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
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
|Contact: Ruquan Han, M.D., Ph.Demail@example.com|
|Beijing TianTan Hospital||Recruiting|
|Beijing, China, 100050|
|Contact: Ruquan Han, M.D., Ph.D 8610-67096660 firstname.lastname@example.org|
|Study Chair:||Ruquan Han, M.D., Ph.D||Department of Anesthesiology, Beijing Tiantan Hospital|