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S-ketamine Prevents Postoperative Pain and Cognitive Dysfunction After Tibial Fracture

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ClinicalTrials.gov Identifier: NCT04643132
Recruitment Status : Not yet recruiting
First Posted : November 24, 2020
Last Update Posted : November 24, 2020
Sponsor:
Information provided by (Responsible Party):
Guolin Wang, Tianjin Medical University General Hospital

Tracking Information
First Submitted Date  ICMJE November 17, 2020
First Posted Date  ICMJE November 24, 2020
Last Update Posted Date November 24, 2020
Estimated Study Start Date  ICMJE December 15, 2020
Estimated Primary Completion Date July 15, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 22, 2020)
Mechanical hyperalgesia threshold on the palms of feet [ Time Frame: 48 hours after surgery ]
The mechanical hyperalgesia threshold was defined as the lowest force (g) necessary to bend a Von Frey filament, which was perceived to be painful by the patient and measured by Von Frey filament.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: November 22, 2020)
  • Pain Score (NRS) [ Time Frame: 48 hours after surgery ]
    The pain score at rest or after movement was evaluated by pain 11-point numerical rating scale (NRS): 0 = no pain, 10 = greatest imaginable pain.
  • Mechanical Hyperalgesia Threshold on the Dominant Inner Forearm [ Time Frame: 48 hours after surgery ]
    The mechanical hyperalgesia threshold was defined as the lowest force (g) necessary to bend a Von Frey filament, which was perceived to be painful by the patient and measured by Von Frey filament
  • Time of First Postoperative Analgesic Requirement [ Time Frame: 1 hour after surgery ]
    First postoperative pain (NRS≥5) is initially controlled by titration of sufentanyl.
  • Total Dose of First Postoperative Analgesic Requirement [ Time Frame: 1 hour after surgery ]
    First postoperative pain (NRS≥5) is initially controlled by titration of sufentanyl.
  • Cumulative Sufentanyl Consumption [ Time Frame: 48 hours after surgery ]
    Each patient was administered analgesics using a PCA (Patient-controlled analgesia) pump containing sufentanil (100μg) in normal saline at a total volume of 100 ml after leaving PACU (Postanesthesia care unit). This device was set to deliver a basal infusion of 2 ml/h and bolus doses of 0.5 ml with a 15-min lockout period. Sufentanyl cumulative consumption is recorded 48 hours postoperatively
  • Occurrence of Side Effects [ Time Frame: 48 hours after surgery ]
    Occurrence of side effects: nausea, vomiting, dizziness, headache, shivering, pruritus
  • Mini-Mental State Examination (MMSE) [ Time Frame: 48 hours after surgery ]
    Cognitive performance was assessed with Mini-Mental State Examination (MMSE).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE S-ketamine Prevents Postoperative Pain and Cognitive Dysfunction After Tibial Fracture
Official Title  ICMJE S-ketamine Prevents Tibial Fracture-associated Postoperative Pain and Cognitive Dysfunction After Orthopedic Surgery in Patients: a Randomized Double-blind Controlled Trial
Brief Summary

Purpose:

To explore effects of S-ketamine on postoperative pain and cognitive dysfunction after tibial fracture and orthopedic surgery.

To evaluate and examine the incidence of adverse effects with the purpose of selecting the optimum dose.

Detailed Description

With the increase in human life span, orthopedic injuries and subsequent repair surgery have become a major health problem which impairs the life quality of patients and burdens healthcare systems worldwide. Poor post-surgical pain control is a leading factor that hinders the physical rehabilitation and musculoskeletal functional recovery, and causes acute cognitive impairment and chronic pain syndrome. Also, existing treatments of opioids and non-steroidal anti-inflammatory drugs have potential drawbacks, which may in turn interfere with bone healing. Therefore, prophylaxis of fracture-associated pain is indispensable to postoperative comfort and satisfaction.

There is no denying the fact that pathologic pain is related to central glutaminergic system and N-methyl-d-aspartate (NMDA) receptor activation induced central sensitization. Also, we previously reported that neuroinflammation is associated with pain development and cognitive dysfunction. Ketamine, a NMDA receptor antagonist, is effective in reversing NMDA receptor activation underlying pain states. But the side effects of ketamine limit its clinical application, such as Delirium, gibberish and agitation. It is clarified that S-ketamine has lower side effects than ketamine and that antinociception of S-ketamine is stronger than ketamine. The following study is carried out to evaluate whether S-ketamine can prevent postoperative pain and cognitive impairment after tibial fracture and orthopedic surgery in patients.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Postoperative Pain
  • Postoperative Cognitive Dysfunction
Intervention  ICMJE
  • Drug: Normal saline
    After the induction of anesthesia, normal saline is intravenously injected in a volume of 2ml, and then a continuous infusion of 20ml/h normal saline until starting skin suture.
    Other Name: 0. 9% Sodium Chloride Injection
  • Drug: S-ketamine
    After the induction of anesthesia, S-ketamine is intravenously injected at 0.2mg/kg, and then a continuous infusion of 0.2mg/kg/h S-ketamine until starting skin suture.
    Other Name: Esketamine Hydrochloride Injection
Study Arms  ICMJE
  • Placebo Comparator: Normal saline in male patients
    After the induction of anesthesia, normal saline is intravenously injected in a volume of 2ml, and then a continuous infusion of 20 ml/h normal saline until starting skin suture.
    Intervention: Drug: Normal saline
  • Placebo Comparator: Normal saline in female patients
    After the induction of anesthesia, normal saline is intravenously injected in a volume of 2ml, and then a continuous infusion of 20 ml/h normal saline until starting skin suture.
    Intervention: Drug: Normal saline
  • Active Comparator: S-ketamine in male patients
    After the induction of anesthesia, S-ketamine is intravenously injected at 0.2mg/kg, and then a continuous infusion of 0.2mg/kg/h S-ketamine until starting skin suture.
    Intervention: Drug: S-ketamine
  • Active Comparator: S-ketamine in female patients
    After the induction of anesthesia, S-ketamine is intravenously injected at 0.2mg/kg, and then a continuous infusion of 0.2mg/kg/h S-ketamine until starting skin suture.
    Intervention: Drug: S-ketamine
Publications *

*   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 Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: November 22, 2020)
120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 15, 2021
Estimated Primary Completion Date July 15, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Subject is scheduled to undergo tibial fracture with orthopedic surgery under a short general anesthesia of less than 2 hours
  2. Subject's American Society of Anesthesiologists physical status is I-II.
  3. The subject's parent/legally authorized guardian has given written informed consent to participate.

Exclusion Criteria:

  1. Subject has a diagnosis of bronchial asthma, coronary heart disease, severe hypertension, renal failure or liver failure.
  2. Subject has a diagnosis of Insulin dependent diabetes.
  3. Subject is allergy and contraindication to S-ketamine.
  4. Subject has a history of chronic pain, a history of alcohol or opioid abuse, pre- existing therapy with opioids, intake of any analgesic drug within 48 hours before surgery.
  5. Subject has any contraindication for the use of patient-controlled analgesia (PCA).
  6. Subject is pregnant or breast-feeding.
  7. Subject is obese (body mass index >30kg/m^2).
  8. Subject is incapacity to comprehend pain assessment and cognitive assessment.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Guolin Wang, MD +8615822855556 wangguolinghad@hotmail.com
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04643132
Other Study ID Numbers  ICMJE GWang011
Has Data Monitoring Committee Yes
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
Plan to Share IPD: No
Responsible Party Guolin Wang, Tianjin Medical University General Hospital
Study Sponsor  ICMJE Tianjin Medical University General Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Guolin Wang, MD Tianjin Medical University General Hospital
PRS Account Tianjin Medical University General Hospital
Verification Date November 2020

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