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Study on Opioid-free Anesthesia Protocol With S-ketamine and Propofol

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ClinicalTrials.gov Identifier: NCT05242081
Recruitment Status : Recruiting
First Posted : February 16, 2022
Last Update Posted : February 16, 2022
Sponsor:
Information provided by (Responsible Party):
The First Affiliated Hospital with Nanjing Medical University

Tracking Information
First Submitted Date  ICMJE January 13, 2022
First Posted Date  ICMJE February 16, 2022
Last Update Posted Date February 16, 2022
Estimated Study Start Date  ICMJE February 2022
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 7, 2022)
Incidence of hemodynamic instability [ Time Frame: From the date of the surgery until the date of the occurrence of hemodynamic instability, assessed up to 2 weeks ]
The incidence of arrythmias, hypertension or hypotension
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: February 7, 2022)
  • Total dosage of anesthesia drug [ Time Frame: From the date of the beginning of anesthesia until the date of the end of anesthesia, assessed up to 2 days ]
  • The duration of surgery [ Time Frame: From the date of the beginning of surgery until the date of the end of surgery, assessed up to 2 days ]
  • Time until awake [ Time Frame: From the end of anesthesia until awake, assessed up to 2 days ]
  • Time to removal of tracheal intubation [ Time Frame: From the end of anesthesia until the time of removal of tracheal intubation, assessed up to 2 days ]
  • Incidence of postoperative nausea and vomiting [ Time Frame: 48 hours after the surgery ]
  • Incidence of postoperative delirium [ Time Frame: 48 hours after the surgery ]
  • Postoperative first analgesia demand [ Time Frame: From the end of anesthesia until the date of first demand of analgesia drugs, assessed up to 1 week ]
    The first time that the patient ask for analgesia
  • Visual analogue score (VAS) pain score at rest [ Time Frame: 24 hours after the surgery ]
  • Visual analogue score (VAS) pain score whilst coughing [ Time Frame: 24 hours after the surgery ]
  • Postoperative hospital stay [ Time Frame: From the date of the surgery until the date being discharged from hospital, up to 1 month ]
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 Study on Opioid-free Anesthesia Protocol With S-ketamine and Propofol
Official Title  ICMJE The Perioperative Effect of an Opioid-free Anesthesia and Opioid Anesthesia in Short Surgery Patients: a Multi-center Prospective Randomized Controlled Trial
Brief Summary The purpose of this study was to observe the effects of opioid-free anesthesia with S-ketamine on perioperative hemodynamics in short surgical operations, and to explore the effects of esketamine on postoperative recovery time, postoperative incidence of nausea, vomiting and delirium, and postoperative pain.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Opioid Use, Unspecified
  • S-ketamine
Intervention  ICMJE
  • Drug: S-ketamine
    S-ketamine 0.5mg/kg for induction and 0.2mg/kg/h for maintenance
  • Drug: Fentanyl
    Fentanyl 4μg/kg for induction and remifentanil 0.05-0.25μg/kg/min for maintenance
Study Arms  ICMJE
  • Experimental: S-ketamine
    Intervention: Drug: S-ketamine
  • Active Comparator: Fentanyl
    Intervention: Drug: Fentanyl
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: February 7, 2022)
1400
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2023
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Aged from 18 years to 70 years
  2. American society of anesthesiologists physical status classification I-II
  3. Patients scheduled for Orthopedic, urological or general surgery (the duration of surgery less than 1 hour)
  4. Willing to sign informed consent

Exclusion Criteria:

  1. Allergic to anesthesia drugs;
  2. Surgical history within the past 1 month;
  3. Severe heart, lung, brain, liver or kidney diseases;
  4. Neurological or mental diseases under treatment;
  5. Inability to understand visual analog scale (VAS).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Ling Zhou +86 15895918786 lingzhou531@foxmail.com
Contact: Chun Yang +8618260062666 chunyang@njmu.edu.cn
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05242081
Other Study ID Numbers  ICMJE 2021-SR-480
Has Data Monitoring Committee No
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 The First Affiliated Hospital with Nanjing Medical University
Original Responsible Party Same as current
Current Study Sponsor  ICMJE The First Affiliated Hospital with Nanjing Medical University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account The First Affiliated Hospital with Nanjing Medical University
Verification Date February 2022

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