Clinical trial

Analgesic Effect of Intraoperative Intravenous S-Ketamine During Total Knee Arthroplasty Surgery:A Randomized Controlled Clinical Trial

Name

YXLL-KY-2021(077)

Description

Severe acute pain after total knee arthroplasty surgery has multiple implications for hospitals and patients, monopolising resources and affecting the quality of life. S-ketamine inhibits N-methyl-d-aspartate (NMDA) receptor activation and attenuates central sensitization associated with hyperalgesia, opioid tolerance.Therefore, the primary aim of this trial was to investigate whether s-ketamine decreases pain and opioid consumption postoperatively in adult individuals undergoing total knee arthroplasty surgery.

Trial arms

Trial start

2022-04-19

Estimated PCD

2024-09-01

Trial end

2024-12-01

Status

Recruiting

Phase

Early phase I

Treatment

sodium chloride (NaCl; 0.9%)

For patients in the control group,anaesthesia will be maintained with intravenous sodium chloride (NaCl; 0.9%) infusion.while anaesthesia will be maintained with propofol infusion(4-12mg/kg/h),analgesia will be maintained with remifentanil(0.15-0.3ug/kg/min).The sufentanil dose at induction and the rate of intraoperative remifentanil and propofol infusions were at the discretion of the anesthesiologist in charge of the patient.The assessment of the depth of anesthesia was based on clinical evaluation,placebo-controlled infusion will be stopped 15 minutes before the end of surgery.Propofol and remifentanil infusion will be stopped at the end of surgery.

Arms:

sodium chloride (NaCl; 0.9%)

S-ketamine

For patients in the s-ketamine group,anaesthesia will be maintained with s-ketamine infusion（0.3mg/kg/h),while anaesthesia will be maintained with propofol infusion(4-12mg/kg/h),analgesia will be maintained with remifentanil(0.15-0.3ug/kg/min).The sufentanil dose at induction and the rate of intraoperative remifentanil and propofol infusions were at the discretion of the anesthesiologist in charge of the patient.The assessment of the depth of anesthesia was based on clinical evaluation.S-ketamine infusion will be stopped 15 minutes before the end of surgery.Propofol and remifentanil infusion will be stopped at the end of surgery.

Arms:

S-ketamine

Size

144

Primary endpoint

at rest and movement, evaluated NRS at 24hours after surgery in the surgical ward.

the patient at 24hours after operation.

Eligibility criteria

Inclusion Criteria: 1. ASA physical statusI-III; 2. Patients understood the study in detail and voluntarily signed the informed consent before the study; 3. Patients to be treated with total knee arthroplasty Surgery under General anesthesia; 4. Elderly patients(≥65y),regardless of gender; 5. Patients can communicate normally; 6. Patients who have no contraindications to drugs such as midazolam,fentanyl,s-ketamine. 7.18 kg/m2 ≤BMI≤30 kg/m2; Exclusion Criteria: 1. Increased intracranial or intraocular pressure; 2. severe hypertension; 3. unwillingness the study; 4. severe psychiatric disease and mental system diseases; 5. severe respiratory diseases; 6. hyperthyroidism; 7. liver and kidney dysfunction; 8. alcohol or drug abuse; 9. allergy to midazolam,fentanyl,s-ketamine.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 144, 'type': 'ESTIMATED'}}

Updated at

2023-02-28

1 organization

2 products

3 indications

Organization

Product

Indication

Indication

Indication

Product