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NCT Number: NCT07372924

A Trial of Tegileridine Fumarate Lnjection for Prolonged Mechanical Ventilation Abirritation in the Intensive Care Unit (ICU)

The purpose of this study is to evaluate the efficacy and safety of Tegileridine Fumarate lnjection for prolonged abirritation(48h to 72h) during mechanical ventilation in the ICU.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Zhongshan Hospital, Shanghai, Shanghai Municipality, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients or their guardians are able to provide a written informed consent
  • Subjects have been treated with endotracheal intubation and mechanical ventilation ≤24h, and then prolonged mechanical ventilation ≥48h in the next
  • Age ≥ 18 and ≤ 85 years, Male or female
  • Body mass index (BMI) > 18 and < 30 kg/m2
  • Use of highly effective contraception for a specified period if applicable

Exclusion criteria

  • Those who are known or suspected to be allergic or contraindicated to various components of the experimental drugs involved in the research institute
  • With an expected survival time of less than 48 hours
  • unable to undergo CPOT and RASS assessments due to various reasons, such as a history of psychiatric disorders, neurological disorders, neurological dysfunction, and consciousness disorders, as well as blindness, deafness, or aphasia
  • Myasthenia gravis, bronchial asthma attack, acute intestinal obstruction, abdominal compartment syndrome
  • Multiple organ failure
  • Malignant tumor Subjects who received radiotherapy, chemotherapy, targeted therapy, and immunotherapy within the first month of randomization
  • Chronic pain requires long-term use of analgesics
  • Severe liver dysfunction
  • Severe renal dysfunction
  • Severe renal dysfunction
  • Need to receive deep sedation or use neuromuscular blocking drugs
  • Surgery or tracheotomy may be required during the study administration period
  • Used monoamine oxidase inhibitors within the two weeks randomization
  • History of drug abuse, drug use, alcohol abuse, and long-term use of psychotropic drugs within 2 years prior to the start of the screening period
  • QTc abnormality during screening period
  • Positive result for infectious disease
  • Positive screening for drug abuse
  • Pregnant or nursing women;
  • Subjects who has Participated in any other clinical trials within the first 3 months of randomization
  • Other conditions deemed unsuitable to be included.

Treatment and study plan

Tegileridine Fumarate lnjection

Drug

Tegileridine Fumarate lnjection; low dose

Remifentanil Hydrochloride for Injection

Drug

Remifentanil Hydrochloride for Injection

Primary outcomes

  1. Rate of abirritation success, abirritation success is defined as the percentage of time maintaining target abirritation in the entire drug administering time ≥ 70%.

    Time frame: within 3 days after administration of research drug

Secondary outcomes

  1. Percentage of time maintaining target abirritation in the entire drug administering time.

    Time frame: within 3 days after administration of research drug

  2. Percentage of subjects receiving rescue analgesic drug

    Time frame: within 3 days after administration of research drug

  3. The total dosage of rescue analgesic drug

    Time frame: within 3 days after administration of research drug

  4. Receiving the total dosage of sedation

    Time frame: within 3 days after administration of research drug

  5. Nursing Scores

    Time frame: within 3 days after discontinuation of research drug

    The investigator will conduct an overall nursing assessment of the subject during the safety follow-up period, and the sum of each score will be calculated : (1) Overall Assessment of Adaptability to Sedation and the Intensive Care Environment, Very Easy=1, Easy =2, Fair =3, Difficult=4; (2) Overall Assessment of Adaptability to Endotracheal Intubation/Ventilation, Good=1, Fair =2,Poor=3; (3) Overall Assessment of Ease of Communication with the Patient, Very Easy=1, Easy =2, Fair =3, Difficult=4, Impossible=5; (4) Overall Assessment of Ease of Patient Care, Good=1, Fair =2,Poor=3.

  6. Mechanical ventilation time.

    Time frame: From research drug administration to actual extubation , up to 72 hours

  7. Extubation time

    Time frame: From discontinuation of research drug to actual extubation , up to 72 hours

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd.

Industry

Registry information

Official study title

A Phase II, Multicenter, Randomized, Single-Blind, Dose Exploration, Positive Comparator Study to Evaluate the Efficacy and Safety of Tegileridine Fumarate Lnjection for Prolonged Mechanical Ventilation Abirritation in the Intensive Care Unit (ICU)

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 28, 2026
Registry last updated
Mar 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.