Status:
UNKNOWN
Safety and Efficacy Evaluation of S (+) - Ketamine in Adults
Lead Sponsor:
Chinese PLA General Hospital
Collaborating Sponsors:
Jiangsu Provincial People's Hospital
Beijing Hospital
Conditions:
Postoperative Pain
Adults
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 sett...
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 exam...
Eligibility Criteria
Inclusion
- 1\. Age ≥18 years old;
- 2\. Scheduled for elective digestive tract surgery, gynecological surgery, urological surgery, thoracic surgery, orthopedic limb surgery, orthopedic spine surgery or body surface surgery (thyroid surgery or breast surgery), head and neck surgery;
- 3\. ASA score Ⅰ～Ⅲ;
- 4\. The informed consent form was signed by the patients.
Exclusion
- 1\. The expected length of hospital stay of the patient is less than 48h;
- 2\. Patients expected to be admitted to the ICU after surgery;
- 3\. Patients expected to return to the ward with tracheal catheter after surgery;
- 4\. Be allergic to S (+) - ketamine;
- 5\. Patients with severe disorder of consciousness or mental system diseases (schizophrenia, mania, bipolar disorder, psychosis, etc.) or cognitive dysfunction;
- 6\. Patients with a history of severe cardiovascular disease (congestive heart failure, severe angina attack, or unstable angina or myocardial infarction within 6 months);
- 7\. Patients during pregnancy or lactation;
- 8\. Patients with MMSE score \<18 points;
- 9\. Patients with any of the following contraindications of S (+) - ketamine:
- Patients with risk of serious rise of blood pressure or intracranial pressure;
- Patients with high intraocular pressure (glaucoma) or penetrating ocular trauma;
- Patients with poorly controlled or untreated hypertension (Resting systolic blood pressure greater than 180 mmHg, or resting diastolic blood pressure greater than 100mmHg);
- Patients with untreated or undertreated hyperthyroidism.
Key Trial Info
Start Date :
May 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2022
Estimated Enrollment :
12000 Patients enrolled
Trial Details
Trial ID
NCT04837170
Start Date
May 1 2021
End Date
June 30 2022
Last Update
April 8 2021
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