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

NCT05289050 | Unknown Phase 4

• 1 other identifier: YXLL-KY-2021(077)
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Pain, Acute; Anaesthetic

Keywords

Postoperative pain; total knee arthroplasty surgery; anaesthetic; S-ketamine infusion

Outcome Measures

Primary Outcomes (1)

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

  NRS = (numerical rating scale) is widely used to measure pain intensity after surgery.NRS is evaluated on a 11-point NRS (0 = no pain, 10 = worst pain imaginable)

  the patient at 24hours after operation.

Secondary Outcomes (6)

• at rest and movement, evaluated NRS at 2 hours after surgery in the surgical ward.

  the patient at 2 hours after operation.

• at rest and movement, evaluated NRS at 48hours after surgery in the surgical ward.

  the patient at 48hours after operation

• The cumulative Opioids consumption during the first 48h after operation

  Within 48hours after surgery

• The number of patients who required additional analgesics during the first 48h after operation

  Within 48hours after surgery

• The Opioids or non-steroid anti-inflammatory drugs total consumption during the first 48h after operation

  Within 48hours after surgery

Study Arms (2)

sodium chloride (NaCl; 0.9%)

PLACEBO COMPARATOR

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.

Drug: sodium chloride (NaCl; 0.9%)

S-ketamine

EXPERIMENTAL

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.

Drug: S-ketamine

Interventions

sodium chloride (NaCl; 0.9%) 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.

sodium chloride (NaCl; 0.9%)

S-ketamine 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.

S-ketamine

Eligibility Criteria

• Age: 65 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• ASA physical statusI-III;
• Patients understood the study in detail and voluntarily signed the informed consent before the study;
• Patients to be treated with total knee arthroplasty Surgery under General anesthesia;
• Elderly patients(≥65y),regardless of gender;
• Patients can communicate normally;
• Patients who have no contraindications to drugs such as midazolam,fentanyl,s-ketamine.
• kg/m2 ≤BMI≤30 kg/m2;

You may not qualify if:

• Increased intracranial or intraocular pressure;
• severe hypertension;
• unwillingness the study;
• severe psychiatric disease and mental system diseases;
• severe respiratory diseases;
• hyperthyroidism;
• liver and kidney dysfunction;
• alcohol or drug abuse;
• allergy to midazolam,fentanyl,s-ketamine.

Sponsors & Collaborators

• Ling Dong: lead

Study Sites (1)

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

Jinan, Shandong, 250000, China

RECRUITING

Related Publications (2)

• Deng SY, Song X, Chen LN, Zhao F, Guo L. The Analgesic Effect of Low-Dose S(+)-Ketamine in Knee Joint Replacement: A Randomized Controlled Trial. J Pain Res. 2025 Nov 4;18:5815-5826. doi: 10.2147/JPR.S545997. eCollection 2025.

  PMID: 41209744 DERIVED

• 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.

  PMID: 38064260 DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Sodium Chloride; Esketamine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Central Study Contacts

Shiyuan Deng, master

CONTACT

13791127650; 13791127650@163.com

Ling Dong, Ph.D

CONTACT

18866862815; dongling1668@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: clinical professor

Study Record Dates

• First Submitted: February 26, 2022
• First Posted: March 21, 2022
• Study Start: April 19, 2022
• Primary Completion: September 1, 2024
• Study Completion: December 1, 2024
• Last Updated: February 28, 2023

Record last verified: 2023-02

Locations

CN (1)