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

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ClinicalTrials.gov Identifier: NCT05289050
Recruitment Status : Recruiting
First Posted : March 21, 2022
Last Update Posted : April 11, 2022
Sponsor:
Information provided by (Responsible Party):
Qianfoshan Hospital

Tracking Information
First Submitted Date  ICMJE February 26, 2022
First Posted Date  ICMJE March 21, 2022
Last Update Posted Date April 11, 2022
Actual Study Start Date  ICMJE January 1, 2022
Estimated Primary Completion Date September 1, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 18, 2022)
at rest and movement, evaluated NRS at 24hours after surgery in the surgical ward. [ Time Frame: the patient at 24hours after operation. ]
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 2, 2022)
  • at rest and movement, evaluated NRS at 2 hours after surgery in the surgical ward. [ Time Frame: the patient at 2 hours after operation. ]
    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)
  • at rest and movement, evaluated NRS at 48hours after surgery in the surgical ward. [ Time Frame: the patient at 48hours after operation ]
    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 cumulative Opioids consumption during the first 48h after operation [ Time Frame: Within 48hours after surgery ]
    The cumulative Opioids consumption such as demerol,sufentanil,morphine
  • The number of patients who required additional analgesics during the first 48h after operation [ Time Frame: Within 48hours after surgery ]
    The number of patients who required additional analgesics such as opioids(demerol,sufentanil,morphine)or non-steroid anti-inflammatory drugs(acetaminophen,diclofenac).
  • The Opioids or non-steroid anti-inflammatory drugs total consumption during the first 48h after operation [ Time Frame: Within 48hours after surgery ]
    The opioids (such as demerol,sufentanil,morphine) or non-steroid anti-inflammatory drugs (such as acetaminophen,diclofenac)total consumption.
  • The incidence of PONV and adverse central nervous system (CNS) events. [ Time Frame: the patient leaves the PACU and at 24, 48hours after operation. ]
    (Postoperative nausea and vomiting)Nausea is defined as subjective,unpleasant sensation associated with awareness of the urge to vomit. Retching is defined as the laboured, spastic, rhythmic contraction of the respiratory muscles without expulsion of the gastric contents.Vomiting is defined as the forceful expulsion of gastric contents from the mouth.The adverse central nervous system (CNS) events(such as nightmares, hallucinations, dizziness, itchy skin) were recorded (yes/no) at the patient leaves the PACU and at 24, 48hours in the surgical ward.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 18, 2022)
  • at rest and movement, evaluated NRS at 2 hours after surgery in the surgical ward. [ Time Frame: the patient at 2 hours after operation. ]
    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)
  • at rest and movement, evaluated NRS at 48hours after surgery in the surgical ward. [ Time Frame: the patient at 48hours after operation ]
    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 cumulative Opioids consumption during the first 48h after operation [ Time Frame: Within 48hours after surgery ]
    The cumulative Opioids consumption such as demerol,sufentanil,morphine
  • The number of patients who required additional analgesics during the first 48h after operation [ Time Frame: Within 48hours after surgery ]
    The number of patients who required additional analgesics such as opioids(demerol,sufentanil,morphine)or non-steroid anti-inflammatory drugs(acetaminophen,diclofenac).
  • The Opioids or non-steroid anti-inflammatory drugs total consumption during the first 48h after operation [ Time Frame: Within 48hours after surgery ]
    The opioids (such as demerol,sufentanil,morphine) or non-steroid anti-inflammatory drugs (such as acetaminophen,diclofenac) total consumption.
  • The incidence of PONV and adverse central nervous system (CNS) events. [ Time Frame: the patient leaves the PACU and at 24, 48hours after operation. ]
    (Postoperative nausea and vomiting)Nausea is defined as subjective,unpleasant sensation associated with awareness of the urge to vomit. Retching is defined as the laboured, spastic, rhythmic contraction of the respiratory muscles without expulsion of the gastric contents.Vomiting is defined as the forceful expulsion of gastric contents from the mouth.The adverse central nervous system (CNS) events(such as nightmares, hallucinations, dizziness, itchy skin) were recorded (yes/no) at the patient leaves the PACU and at 24, 48hours in the surgical ward.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Analgesic Effect of Intraoperative Intravenous S-Ketamine After Total Knee Arthroplasty Surgery
Official Title  ICMJE Analgesic Effect of Intraoperative Intravenous S-Ketamine After Total Knee Arthroplasty Surgery:A Randomized Controlled Clinical Trial
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 .

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Other
Condition  ICMJE
  • Postoperative Pain, Acute
  • Anaesthetic
Intervention  ICMJE
  • Drug: 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.
  • 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.
Study Arms  ICMJE
  • Placebo Comparator: 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: Drug: sodium chloride (NaCl; 0.9%)
  • Experimental: 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: Drug: S-ketamine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 18, 2022)
144
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 1, 2024
Estimated Primary Completion Date September 1, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years to 90 Years   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Shiyuan Deng, master 13791127650 13791127650@163.com
Contact: Ling Dong, Ph.D 18866862815 dongling1668@163.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05289050
Other Study ID Numbers  ICMJE YXLL-KY-2021(077)
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Qianfoshan Hospital
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Qianfoshan Hospital
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Qianfoshan Hospital
Verification Date March 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP