Analgesic Effect of Intraoperative Intravenous S-Ketamine During Total Knee Arthroplasty Surgery

NCT ID: NCT05289050

Last Updated: 2023-02-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 144 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-19
• Study Completion Date: 2024-12-01

Brief Summary

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.

Detailed Description

Total knee arthroplasty surgery is considered a cost-effective therapy for end-stage knee osteoarthritis (KOA). With an ageing population and rising rates of obesity in the world, knee joint replacements are estimated to escalate. While joint replacement is a cost effective intervention,approximately 20% of people experience persist pain postoperatively. The surgical injury triggers a myriad of responses in the pain matrix, from sensitization of peripheral and central pain pathways to feelings of fear, anxiety and frustration.

Opioids are effective for acute postoperative pain but have numerous adverse effects. In addition, postoperative opioid treatment may pose a risk of opioid addiction.

Numerous publications state that adjuvant s-ketamine reduces pain and opioid consumption postoperatively . Whether intraoperative intravenous s-ketamine alleviates postoperative acute pain after total knee arthroplasty surgery still unclear . Therefore, a randomized, controlled, clinical study was designed to observed analgesic effect intraoperative intravenous a lower doses of s-ketamine(0.3mg/kg/h) with patients after total knee arthroplasty surgery .

Conditions

Postoperative Pain, Acute; Anaesthetic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: PLACEBO_COMPARATOR

sodium chloride (NaCl; 0.9%)

Intervention Type: DRUG

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.

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.

Group Type: EXPERIMENTAL

S-ketamine

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ling Dong

OTHER

Sponsor Role: lead

Responsible Party

Ling Dong

clinical professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Qianfoshan Hospital, The First Hospital affiliated of Shandong First Medical University

Jinan, Shandong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Shiyuan Deng, master

Role: CONTACT

13791127650@163.com

13791127650

Ling Dong, Ph.D

Role: CONTACT

dongling1668@163.com

18866862815

Facility Contacts

Ling Dong, Ph.D

Role: primary

dongling1668@163.com

18866862815

References

Deng S, Chen L, Song X, Guo L, Zhao F, Liu J, Dong L. Analgesic Effect of Intraoperative Intravenous S(+)-Ketamine During Total Knee Arthroplasty Surgery: Study Protocol for a Randomized Controlled Clinical Trial. JMIR Res Protoc. 2023 Dec 8;12:e53063. doi: 10.2196/53063.

Reference Type: DERIVED

PMID: 38064260 (View on PubMed)

Other Identifiers

YXLL-KY-2021(077)

Identifier Type: -

Identifier Source: org_study_id