Safety and Efficacy Evaluation of S (+) - Ketamine in Adults

Chinese PLA General Hospital (301 Hospital)

Status and phase: Unknown; Phase 4

Conditions: Postoperative Pain; Adults; Anesthesia

Treatments: Drug: Conventional therapy; Drug: Conventional therapy + S (+)-Ketamine

Study type: Interventional

Funder types: Other

Identifiers

NCT04837170

SAFE-SK-A

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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:

  10. Patients with risk of serious rise of blood pressure or intracranial pressure;

  11. Patients with high intraocular pressure (glaucoma) or penetrating ocular trauma;

  12. Patients with poorly controlled or untreated hypertension (Resting systolic blood pressure greater than 180 mmHg, or resting diastolic blood pressure greater than 100mmHg);

  13. Patients with untreated or undertreated hyperthyroidism.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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12,000 participants in 2 patient groups

S (+)-Ketamine group

Experimental group

Description:

Drug: Conventional therapy + S (+)-Ketamine In principle, there are no specific restrictions on the dosage, mode of administration, timing, and compatibility of S-ketamine hydrochloride injection,but the recommended dosage is given, which is lower than the dosage specified in the instructions. Recommended use and dosage of S (+)-Ketamine: 1. Bolus intravenous injection before skin incision, the dose is 0.1\~0.5 mg/kg; 2. Bolus intravenous injection (dose 0.1\~0.5 mg/kg) before skin incision +continuous intravenous infusion (dose of 0.1\~0.25 mg/kg/h) during operation; 3. Continuous intravenous infusion after surgery with a dose of 0.02\~0.1 mg/kg/h for 24\~48 h.

Treatment:

Drug: Conventional therapy + S (+)-Ketamine

Control group

Active Comparator group

Description:

Drug: Conventional therapy Receiving conventional therapy without S (+)-Ketamine hydrochloride injection. There is no restrictions in drugs, doses and incompatibility, the researchers can choose appropriate medication regimens based on clinical practice, but other NMDA receptor antagonists are not be allowed to use, such as dextromethorphan and amantadine.

Treatment:

Drug: Conventional therapy