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Effect of Intravenous S-ketamine on Opioid Consumption

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ClinicalTrials.gov Identifier: NCT05060068
Recruitment Status : Recruiting
First Posted : September 28, 2021
Last Update Posted : November 23, 2021
Sponsor:
Information provided by (Responsible Party):
Yun Wu, The Second Hospital of Anhui Medical University

Tracking Information
First Submitted Date  ICMJE August 22, 2021
First Posted Date  ICMJE September 28, 2021
Last Update Posted Date November 23, 2021
Estimated Study Start Date  ICMJE November 22, 2021
Estimated Primary Completion Date July 7, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 23, 2021)
consumption of sufentanil [ Time Frame: during the surgery ]
the consumption of sufentanil during the surgery.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 23, 2021)
  • postoperative pain assessment [ Time Frame: at 0.5, 2, 4, 6, 12 and 24 hours respectively after surgery; Month 3 and Month 6 after surgery ]
    Patients will be asked about their pain level at rest and moving on a numeric rating scale evaluated on a 11-point (0 = no pain, 10 = worst pain imaginable).
  • consumption of analgesics [ Time Frame: in the first 24 hour after surgery ]
    cumulative analgesic consumption after surgery
  • Richmond Agitation-Sedation Scale (RASS) [ Time Frame: 30 minutes after surgery ]
    Richmond Agitation-Sedation Scale is a 10-point scale. The values and definitions for each level of agitation and sedation are displayed as follows: +4, Combative, overtly combative or violent; immediate danger to staff; +3, Very agitation, pulls on or removes tube(s) or catheter(s) or has aggressive behavior toward staff; +2, Agitated, frequent nonpurposeful movement or patient-ventilator dyssynchrony; +1, Restless, anxious or apprehensive but movements not aggressive or vigorous; 0, Alert and calm; -1, Drowsy, not fully alert, but has sustained (more than 10 seconds) awakening, with eye contact, to voice; -2, Light sedation, briefly (less than 10 seconds) awakens with eye contact to voice; -3, Moderate sedation, any movement (but no eye contact) to voice; -4, Deep sedation, no response to voice, but any movement to physical stimulation; -5, Unarousable, no response to voice or physical stimulation
  • sleep quality scale [ Time Frame: sleep quality scale will be assessed in the morning (8:00 am)of first postoperative day ]
    Quality of sleep in the night of surgery day using a 4-point scale (1 = "slept well," 2 = "disturbed sleep," 3 = "nightmares," and 4 = "sleepless") will be recorded.
  • consumption of propofol [ Time Frame: during the surgery ]
    the consumption of propofol during the surgery.
  • consumption of remifentanil [ Time Frame: during the surgery ]
    the consumption of remifentanil during the surgery.
  • length of anesthesia [ Time Frame: at the end of anesthesia ]
    from beginning to the end of anesthesia
  • length of surgery [ Time Frame: at the end of surgery ]
    from beginning to the end of surgery
  • recovery time [ Time Frame: at the time when patients waking up ]
    awakening time from surgery
  • consumption of vasoactive agents [ Time Frame: during the surgery ]
    the consumption of any vasoactive agent (such as phenylephrine, urapidil, ephedrine)
  • blood pressure [ Time Frame: before anesthesia, prior to incision, 5, 10, 30, 60 and 120 minutes after incision, at the end of surgery and 30 minutes after surgery ]
    noninvasive blood pressure
  • heart rate [ Time Frame: before anesthesia, prior to incision, 5, 10, 30, 60 and 120 minutes after incision, at the end of surgery and 30 minutes after surgery ]
    Heart rate of the patients
  • bispectral index [ Time Frame: before anesthesia, prior to incision, 5, 10, 30, 60 and 120 minutes after incision, at the end of surgery and 30 minutes after surgery ]
    Bispectral index during the surgery
  • adverse effects [ Time Frame: through 24 hours after the surgery ]
    The presence of intraoperative awareness, nausea, vomiting, and hallucinations after surgery
  • Edinburgh postnatal depression scale [ Time Frame: before surgery and at the 7th day after surgery ]
    Depression scale generated from Edinburgh postnatal depression scale will be assessed. The minimum value is 0, and the maximum value is 30. The higher score means the higher possibility of depression.
  • ambulation time [ Time Frame: 7 days after surgery ]
    interval time of patients' transit from bed rest to ambulation after surgery
  • hospitalization postoperatively [ Time Frame: two weeks after surgery ]
    days of hospital staying after surgery
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 Effect of Intravenous S-ketamine on Opioid Consumption
Official Title  ICMJE Effect of Intravenous S-ketamine on Opioid Consumption and Postoperative Pain in Patients Undergoing Breast Cancer Surgery:a Multicenter, Randomised, Control Trial
Brief Summary Female patients with an American Society of Anesthesia (ASA) physical status I-II, scheduled for elective breast cancer surgery will be included in the study. Subjects will be randomly assigned to one of three groups: the placebo group, the low-dose S-ketamine group, and the high-dose S-ketamine group. The primary outcome is the consumption of sufentanil during the surgery.
Detailed Description

All patients will be scheduled to a propofol-remifentanil general anesthesia and receive non-steroid anti-inflammatory drug before incision. Bolus sufentanil will be administered according to the blood pressure, heart rate and bispectral index perioperatively. Patients unable to understand the study procedure or unable to give informed consent, with concurrent analgesic or sedative medication, with history of chronic pain, psychiatric disorders, or alcohol or drug abuse, with an allergy to the study medication, who are pregnant or breast feeding, with a BMI >30 and <18 kg/m2, with severe cardiac, pulmonary, hepatic or renal dysfunction, with intracranial hypertension will be excluded.

Subjects will be randomly assigned to one of three groups: the placebo group, the low-dose S-ketamine group, and the high-dose S-ketamine group. The study medication will be administered in a bolus injected over 30 s after induction, followed by continuous infusion, which started after the initial bolus. The placebo group will receive a bolus of 0.9% saline, followed by continuous infusion of 0.9% saline. The low-dose ketamine group will be administered a bolus of 0.5 mg/kg S-ketamine in saline, followed by 2μg/kg/min S-ketamine in saline, whereas the high-dose ketamine group will be administered a bolus of 0.5 mg/kg S-ketamine in saline, followed by continuous infusion of 4μg/kg/min S-ketamine in saline. The syringes and infusions will be identical for all of the groups and will run at the same rate in all subjects to enable blinding of the investigators. Study medication will be terminated 30 min prior to the end of the surgery. After surgery and in the postanesthesia care unit, patients will be asked about their pain level on a numeric rating scale (NRS), and about the presence of intraoperative awareness, nausea, vomiting, and hallucinations. Rescue analgesia of sufentanil will be provided when NRS ≥ 4 or patients require. Pain level will also be assessed at 0.5, 2, 4, 6, 12 and 24 hour postoperatively as well as 3 and 6 month after the surgery. Depression scale will be evaluated before the surgery and in the 7th postoperative day.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
The syringes and infusions will be identical for all of the groups and will run at the same rate in all subjects to enable blinding of the investigators. Outcomes will be evaluated by anesthesiologists who are blinded to the treatment allocation. Patients, nurses, observers, and the statistician will be blinded to patient allocation throughout the study period.
Primary Purpose: Treatment
Condition  ICMJE Breast Cancer Surgery
Intervention  ICMJE
  • Drug: S-ketamine (low dose)
    Patients in the low-dose ketamine group will receive a bolus of 0.5 mg/kg S-ketamine in saline, followed by continuous infusion of 2 μg/kg/min S-ketamine in saline until 30 min prior to the end of the surgery.
    Other Name: LKET
  • Drug: Placebo
    Patients in the placebo group will receive a bolus of 0.9% saline, followed by continuous infusion of 0.9% saline until 30 min prior to the end of the surgery.
    Other Name: CON
  • Drug: S-ketamine (high dose)
    Patients in the high-dose ketamine group will receive a bolus of 0.5 mg/kg S-ketamine in saline, followed by continuous infusion of 4 μg/kg/min S-ketamine in saline until 30 min prior to the end of the surgery.
    Other Name: HKET
Study Arms  ICMJE
  • Placebo Comparator: Placebo group
    Patients in the placebo group will receive a bolus of 0.9% saline, followed by continuous infusion of 0.9% saline until 30 min prior to the end of the surgery.
    Intervention: Drug: Placebo
  • Experimental: Low-dose ketamine group
    Patients in the low-dose ketamine group will receive a bolus of 0.5 mg/kg S-ketamine in saline, followed by continuous infusion of 2 μg/kg/min S-ketamine in saline until 30 min prior to the end of the surgery.
    Intervention: Drug: S-ketamine (low dose)
  • Experimental: High-dose ketamine group
    Patients in the low-dose ketamine group will receive a bolus of 0.5 mg/kg S-ketamine in saline, followed by continuous infusion of 4 μg/kg/min S-ketamine in saline until 30 min prior to the end of the surgery.
    Intervention: Drug: S-ketamine (high dose)
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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 23, 2021)
825
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 7, 2022
Estimated Primary Completion Date July 7, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Female patients with an American Society of Anesthesia (ASA) physical status I-II
  2. Scheduled for elective breast cancer surgery

Exclusion Criteria:

  1. Patients unable to understand the study procedure or unable to give informed consent
  2. with concurrent analgesic or sedative medication,
  3. with history of chronic pain
  4. with history of psychiatric disorders
  5. with history of alcohol or drug abuse
  6. with an allergy to the study medication
  7. who are pregnant or breast feeding
  8. with a BMI >30 and <18 kg/m^2
  9. with severe cardiac, pulmonary, hepatic or renal dysfunction
  10. with intracranial hypertension
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Yun Wu, M.D., Ph. D. +8613865958254 wuyunanyi@163.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05060068
Other Study ID Numbers  ICMJE YX2021-070(F1)
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
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: All IPD that underlie results in a publication are to be shared with other researchers.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Supporting Materials: Analytic Code
Time Frame: The IPD will become available when summary data are published.
Access Criteria: Yun Wu and Ye Zhang will review requests and criteria to share IPD. Requests are to be sent by email to wuyunanyi@163.com or zhangye_hassan@sina.com.
Responsible Party Yun Wu, The Second Hospital of Anhui Medical University
Study Sponsor  ICMJE The Second Hospital of Anhui Medical University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Ye Zhang, M.D., Ph. D. The Second Hospital of Anhui Medical University
PRS Account The Second Hospital of Anhui Medical University
Verification Date November 2021

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