CClinicalTrials.gg
Sign In
CompletedNCT07036419Updated Jun 4, 2026

A Trial of Remimazolam for Intraoperative Sedation in Pediatric and Adolescent Patients

A Phase 2/3 interventional study of Remimazolam Tosilate for injection and Propofol Injection in Operative Sedation of Pediatric and Operative Sedation of Adolescent Patients, sponsored by Jiangsu HengRui Medicine Co., Ltd.. Completed at 1 site in China. Open to participants aged 3 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-06-04.

Sponsored by Jiangsu HengRui Medicine Co., Ltd. · Phase 2/3, Interventional, and Treatment

Phase
Phase 2/3
Study type
Interventional
Enrollment
249
Allocation
Randomized
Ages
3 Years to 17 Years
Sex
All
01

Study summary

The study is being conducted to evaluate the efficacy and safety of Remimazolam for intraoperative sedation in pediatric and adolescent patients.

02

Conditions studied

  • Operative Sedation of Pediatric
  • Operative Sedation of Adolescent Patients
03

In context

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd. is the lead sponsor of 559 studies on the registry; 85 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 1 (11%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
3 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Able and willing to provide a written informed consent.
  2. Subjects requiring elective general anesthesia surgery.
  3. Male or female.
  4. Meet the weight standard.

Exclusion criteria

Exclusion Criteria:

  1. Pediatric patients scheduled for elective cardiothoracic, neurosurgical, or hepatic surgery.
  2. Patients who are planned to receive any anesthetic techniques other than total intravenous anesthesia (TIVA) from entry into the operating room until the end of surgery, such as inhalational anesthesia, epidural anesthesia, or spinal anesthesia.
  3. Patients with a medical history or clinical evidence that may increase the risk of sedation or anesthesia and are deemed unsuitable for participation by the investigator.
  4. Patients with a history of asthma or with risk for difficult mask ventilation or difficult intubation by the investigator's judgment.
  5. With clinically significant abnormal clinical laboratory test value.
  6. Known intolerance or allergy to benzodiazepines, propofol, opioids, neuromuscular blocking agents, or any of their components.
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
249 participants (actual)

Study arms

  • Experimental
    Remimazolam Group

    Drug: Remimazolam Tosilate for injection

  • Active comparator
    Propofol Group

    Drug: Propofol Injection

Interventions

  • DrugRemimazolam Tosilate for injection

    Remimazolam Tosilate for injection.

  • DrugPropofol Injection

    Propofol injection.

06

What researchers measure

Primary outcomes

  1. The overall sedation success rate.

    The overall sedation success rate, which encompasses both successful induction of sedation and successful maintenance of adequate sedation throughout the anesthesia procedure.

    Time frame: Throughout the anesthesia procedure.

Secondary outcomes

  1. Proportion of subjects with hemodynamic instability.

    Defined as a ≥ ±20% change from the baseline in blood pressure or heart rate.

    Time frame: Up to 2 days.

  2. Incidence and severity of adverse events during the study.

    Time frame: Up to 3 days.

07

Study locations

1 site
  • Shanghai Children's Medical Center Affiliated to Shanghai Jiao Tong University School of Medicine
    Shanghai, Shanghai Municipality 200433, China
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 4, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07036419
Lead sponsor
Jiangsu HengRui Medicine Co., Ltd.
Responsible party
Sponsor
First posted
Jun 25, 2025
Start date
Jul 10, 2025
Primary completion
May 27, 2026
Completion
May 27, 2026
Last update
Jun 4, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

Jiangsu HengRui Medicine Co., Ltd.

Start the discussion