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

Ketamine

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.

Intervention / Treatment

  • S-ketamine (DRUG)
    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.
  • Placebo (DRUG)
    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.

Condition or Disease

  • S-ketamine
  • Analgesia, Patient-Controlled
  • Cesarean Section

Phase

  • Phase 4

    • Study Design

    Study type: INTERVENTIONAL
    Status: Recruiting
    Study results: No Results Available
    Age: 20 Years to 40 Years
    Enrollment: 216 (ESTIMATED)
    Allocation: Randomized
    Primary Purpose: Treatment

    Masking

    SINGLE:
    • Participant

    Clinical Trial Dates

    Start date: Apr 12, 2022 ACTUAL
    Primary Completion: May 31, 2024 ESTIMATED
    Completion Date: Jun 30, 2024 ESTIMATED
    Study First Posted: Mar 29, 2022 ACTUAL
    Last Updated: Feb 25, 2023

    Sponsors / Collaborators

    Lead Sponsor: N/A
    Responsible Party: N/A

    Participant Groups

    • The pump is established with S-ketamine 1mg/kg, sufentanil 2microgram/kg, andondansetron16mg, diluted with normal saline to 100 ml.

    • The pump is established with sufentanil 2microgram/kg, andondansetron16mg, diluted with normal saline to 100 ml.

    Eligibility Criteria

    Sex: Female
    Minimum Age: 20
    Maximum Age: 40
    Age Groups: Adult
    Healthy Volunteers: Yes

    Inclusion Criteria:

    * American Society of Anesthesiologists (ASA) physical status 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

    This clinical trial is recruiting

    Are you interested in participating in this trial or others? We'd love to help.

    Primary Outcomes

    • 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.

    Secondary Outcomes

    • Pain is assessed with a numeric rating scale (NRS; an 11-point scale where 0=no pain and 10=the worst pain)

    Other Outcomes

    • The total number of presses of PCA

    • The percentage of using rescue analgesics

    • Sedation is assessed with a numeric rating scale(RASS;an 10-point scale with -5 to +4)

    • postoperative adverse event with nausea,vomiting,dizziness,nightmares, hallucination and etc

    More Details

    NCT Number: NCT05299866
    Other IDs: YXLL-KY-2021(071)
    Study URL: https://clinicaltrials.gov/study/NCT05299866
    Last updated: Sep 29, 2023