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Efficacy and Safety of Anrikefon Injection for Multimodal Postoperative Analgesia in Patients Undergoing Laparoscopic Hepatectomy

ConditionPostoperative Acute Pain
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorSun Yat-Sen Memorial Hospital of Sun Yat-Sen University

About this trial

A single-center, randomized, double-blind, placebo-controlled trial design will be adopted to investigate whether Anruikefon can significantly reduce the consumption of sufentanil via PCIA pumps within 48 hours postoperatively compared with placebo.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged ≥ 18 years;

American Society of Anesthesiologists (ASA) physical status classification I-III;

Body mass index (BMI): 18 kg/m² ≤ BMI ≤ 30 kg/m²;

Patients scheduled to undergo laparoscopic hepatectomy under general anesthesia with estimated operation duration ≤ 5 hours;

Disqualifiers

Patients with a history of severe cardiopulmonary disease, neuropsychiatric disorders, digestive system diseases, chronic dizziness or vestibular dysfunction;

Patients undergoing emergency surgery or trauma patients;

Intraoperative conversion to open laparotomy;

History of abdominal surgery within the past 3 months;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Anruikefon 1 μg/kg per dose Group

    Drug

    Anruikefon 1 μg/kg/dose, once every 8 hours (q8h), for a total of 6 doses.

  • Anruikefon 100 μg per dose Group

    Drug

    Anruikefon 100 μg per dose, once every 8 hours (q8h), for a total of 6 doses.

  • Control group

    Drug

    0.9% Sodium Chloride Injection, via intravenous bolus injection, once every 8 hours (q8h), for a total of 6 doses.

Treatment groups

117 Participants
are divided into 3 treatment groups
Group A: Anruikefon 1 μg/kg per dose GroupExperimental treatment 1 intervention
Group B: Anruikefon 100 μg per dose GroupExperimental treatment 1 intervention
Group C: Placebo GroupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Consumption of sufentanil via PCIA within 48 hours after the first study drug administration

Time frame
0-48 hours post first study drug dose

Secondary outcomes

1

Proportion of rescue analgesia

Time frame
Within0-24 hours and 0-48 hours after the first study drug administration
2

Cumulative consumption dose of rescue analgesia

Time frame
within 0-24 hours and 0-48 hours after the first study drug administration
3

Time from end of surgery to first passage of flatus (hours)

Time frame
Throughout the inpatient hospital stay after surgery, from the end of surgery until the first flatus occurs
4

Time from end of surgery to first defecation (hours)

Time frame
Throughout the inpatient hospital stay after surgery, from the end of surgery until the first defecation occurs

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: