Safety and Efficacy Evaluation of S (+) - Ketamine in Adults
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ClinicalTrials.gov Identifier: NCT04837170 |
Recruitment Status :
Not yet recruiting
First Posted : April 8, 2021
Last Update Posted : April 8, 2021
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Tracking Information | |||||||||
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First Submitted Date ICMJE | April 6, 2021 | ||||||||
First Posted Date ICMJE | April 8, 2021 | ||||||||
Last Update Posted Date | April 8, 2021 | ||||||||
Estimated Study Start Date ICMJE | May 1, 2021 | ||||||||
Estimated Primary Completion Date | June 1, 2022 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | No Changes Posted | ||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | Safety and Efficacy Evaluation of S (+) - Ketamine in Adults | ||||||||
Official Title ICMJE | Safety and Efficacy Evaluation of S(+)-Ketamine for Postoperative Acute Pain in Adults in Perioperative Settings: A Multicenter, Randomized, Open-label, Active Controlled Pragmatic Clinical Trial | ||||||||
Brief Summary | A multicenter, randomized, open-label, active controlled pragmatic clinical trial that evaluates the safety and efficacy of S (+) -ketamine for postoperative acute pain in adults in perioperative settings. | ||||||||
Detailed Description | Patients often suffer acute pain after operation ,which may affect the recovery. Opioid such as morphine is the most commonly analgesic drugs, but opioid has many obviously adverse reactions ,for example respiratory depression,circulation inhibition,tolerance, addiction, nausea, vomiting, pruritus, etc. S (+) - ketamine has been described to decrease acute pain and opioid consumption,but it needs to confirm for chinese patients undergoing surgery. Objective:Evaluate the efficacy and safety of S (+) - ketamine on acute perioperative pain for chinese adult patients,and look for the best dosage, mode of administration, timing, and compatibility ,as well explore the effect of S (+) - ketamine on postoperative delirium,anxiety ,depression and cognitive dysfunction. |
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Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Phase 4 | ||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: Experimental group : Control group=2:1 Masking: None (Open Label)Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Wang H, Duan CY, Huang WQ, Zhao P, Zhou LZ, Liu YH, Liu CM, Chu HC, Wang Q, Diao YG, Hua Z, Meng QT, Li H, Zhang XY, Mi WD, Chen PY. Perioperative intravenous S(+)-ketamine for acute postoperative pain in adults: study protocol for a multicentre, randomised, open-label, positive-controlled, pragmatic clinical trial (SAFE-SK-A trial). BMJ Open. 2021 Dec 16;11(12):e054681. doi: 10.1136/bmjopen-2021-054681. | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Not yet recruiting | ||||||||
Estimated Enrollment ICMJE |
12000 | ||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||
Estimated Study Completion Date ICMJE | June 30, 2022 | ||||||||
Estimated Primary Completion Date | June 1, 2022 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | Not Provided | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT04837170 | ||||||||
Other Study ID Numbers ICMJE | SAFE-SK-A | ||||||||
Has Data Monitoring Committee | No | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Weidong Mi, Chinese PLA General Hospital | ||||||||
Original Responsible Party | Same as current | ||||||||
Current Study Sponsor ICMJE | Chinese PLA General Hospital | ||||||||
Original Study Sponsor ICMJE | Same as current | ||||||||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | Chinese PLA General Hospital | ||||||||
Verification Date | April 2021 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |