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The Effect of S-ketamine Combined With Sufentanil for Postoperative PCIA in Patients Following Cesarean Section

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ClinicalTrials.gov Identifier: NCT05299866
Recruitment Status : Recruiting
First Posted : March 29, 2022
Last Update Posted : June 1, 2022
Sponsor:
Information provided by (Responsible Party):
Qianfoshan Hospital

Tracking Information
First Submitted Date  ICMJE February 26, 2022
First Posted Date  ICMJE March 29, 2022
Last Update Posted Date June 1, 2022
Actual Study Start Date  ICMJE April 12, 2022
Estimated Primary Completion Date May 31, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 18, 2022)
The percentage of patients with moderate-to-severe pain [ Time Frame: Up to 48 hours after surgery ]
Moderate-to-severe pain is defined as a numeric rating scale (NRS; an 11-point scale where 0=no pain and 10=the worst pain) pain score ≥4.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 18, 2022)
NRS pain score at rest and with movement [ Time Frame: Hour 12 & Hour 24 & Hour 48 after surgery ]
Pain is assessed with a numeric rating scale (NRS; an 11-point scale where 0=no pain and 10=the worst pain)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: May 26, 2022)
  • The total number of presses of PCA [ Time Frame: Up to 48 hours after surgery ]
    The total number of presses of PCA
  • The percentage of using rescue analgesics [ Time Frame: Up to 48 hours after surgery ]
    The percentage of using rescue analgesics
  • The Richmond Agitation-Sedation Scale(RASS) [ Time Frame: Hour 12 & Hour 24 & Hour 48 after surgery ]
    Sedation is assessed with a numeric rating scale(RASS;an 10-point scale with -5 to +4)
  • The incidence of postoperative adverse event [ Time Frame: Up to 48 hours after surgery ]
    postoperative adverse event with nausea,vomiting,dizziness,nightmares, hallucination and etc
Original Other Pre-specified Outcome Measures
 (submitted: March 18, 2022)
  • The number of valid presses and total number of presses of PCA [ Time Frame: Hour 12 & Hour 24 & Hour 48 after surgery ]
    The number of valid presses and total number of presses of PCA
  • The percentage of using rescue analgesics [ Time Frame: Hour 12 & Hour 24 & Hour 48 after surgery ]
    The percentage of using rescue analgesics
  • The Richmond Agitation-Sedation Scale(RASS) [ Time Frame: Hour 12 & Hour 24 & Hour 48 after surgery ]
    Sedation is assessed with a numeric rating scale(RASS;an 10-point scale with -5 to +4)
  • The incidence of postoperative adverse event [ Time Frame: Hour 12 & Hour 24 & Hour 48 after surgery ]
    postoperative adverse event with nausea,vomiting,dizziness,nightmares, hallucination and etc
 
Descriptive Information
Brief Title  ICMJE The Effect of S-ketamine Combined With Sufentanil for Postoperative PCIA in Patients Following Cesarean Section
Official Title  ICMJE The Effect of Low-dose of S-ketamine Combined With Sufentanil for Postoperative Patient-controlled Intravenous Analgesia in Patients Following Cesarean Section
Brief Summary This randomized controlled trial is designed to investigate the effect of low-dose of S-ketamine combined with sufentanil for postoperative patient-controlled intravenous analgesia in patients following cesarean section.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE
  • S-ketamine
  • Analgesia, Patient-Controlled
  • Cesarean Section
Intervention  ICMJE
  • Drug: S-ketamine
    After surgery, patient-controlled analgesia is provided. The pump is established with S-ketamine 1mg/kg, sufentanil 2microgram/kg, andondansetron16mg, diluted with normal saline to 100 ml. The pump is programmed to deliver 2 ml boluses with a background infusion rate at 2 ml /h and a 30 min lockout interval.
  • Drug: Placebo
    After surgery, patient-controlled analgesia is provided. The pump is established with sufentanil 2microgram/kg, andondansetron16mg, diluted with normal saline to 100 ml. The pump is programmed to deliver 2 ml boluses with a background infusion rate at 2 ml /h and a 30 min lockout interval.
Study Arms  ICMJE
  • Experimental: S-ketamine group
    The pump is established with S-ketamine 1mg/kg, sufentanil 2microgram/kg, andondansetron16mg, diluted with normal saline to 100 ml.
    Intervention: Drug: S-ketamine
  • Placebo Comparator: Control group
    The pump is established with sufentanil 2microgram/kg, andondansetron16mg, diluted with normal saline to 100 ml.
    Intervention: Drug: Placebo
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: March 18, 2022)
216
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2023
Estimated Primary Completion Date May 31, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • ASA physical status I-II
  • Patients aged between 20 and 40 years
  • 18 kg/m² ≤BMI≤30 kg/m²
  • singleton term pregnancy
  • scheduled for elective cesarean section

Exclusion Criteria:

  • Refused to participant in this trial
  • Severe heart dysfunction or pulmonary insufficiency
  • Poor blood pressure control in those with hypertension (BP >160/100 mmHg in the ward)
  • Previous history of Intracranial hypertension or hyperthyroidism
  • Previous history of schizophrenia, epilepsy, myasthenia gravis or delirium
  • Allergy to drugs used in the study
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 20 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Ling Dong, Ph.D 18866862815 dongling1668@163.com
Contact: Ling Dong, MD 18866862815 dongling1668@163.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05299866
Other Study ID Numbers  ICMJE YXLL-KY-2021(071)
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
Plan to Share IPD: No
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 May 2022

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