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Clinical study on the safety and efficacy of oliceridine for tracheal intubation in children

Randomized, double-blind, active-controlled trial comparing the safety and efficacy of oliceridine versus sufentanil for tracheal intubation during induction of general anesthesia in children: a noninferiority evaluation based on hemodynamic stability and intubation condition

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500115753
Enrollment
Unknown
Registered
2025-12-30
Start date
2026-01-01
Completion date
Unknown
Last updated
2026-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

General Functional Domain

Interventions

Group O(oliceridine group):oliceridine was administered intravenously at an initial dose of 70ug/kg.If the cardiovascular response to intubation was negative,the dose was deemed to be effective,and th
If the cardiovascular response is positive,it is considered a failure, and the dose of the next child is increased by 0.05ml/kg.
Group S(sufentanil group):Sufentanil was administered intravenously at an initial dose of 0.3 ug/kg. If the cardiovascular response to intubation was negative, the dose was deemed to be effective, an
If the cardiovascular response is positive, it is considered a failure, and the dose of the next child is increased by 0.05 ml/kg.

Sponsors

Shanghai Children's Medical Center, Shanghai Jiao Tong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Years to 12 Years

Inclusion criteria

Inclusion criteria: 1.Age 1-12 years; 2.Gender not restricted; 3.Children undergoing general anesthesia with endotracheal intubation; 4.ASA classification grade I-II; 5. BMI18-27 kg/m^2.

Exclusion criteria

Exclusion criteria: 1.Preoperative symptoms of nausea and vomiting; 2.Children who have already been administered sedative medications prior to surgery; 3.Children with severe malnutrition; 4.Children with a history of anesthesia within 7 days; 5.Children who are allergic to anesthetic drugs such as oliceridine remimazolam ,sevoflurane ,rocuronium bromide; 6.Children suspected of having difficult mask ventilation or difficult tracheal intubation; 7.Severe combined cardiopulmonary diseases,neurological disorders,or significant abnormalities in liver and kidney function 8.Children on long-term opioid therapy; 9.The family members refused to participate in this study.

Design outcomes

Primary

MeasureTime frame
ED90 of oliceridine inhibiting Cardiovascular Response to Endotracheal Intubation;

Secondary

MeasureTime frame
Duration of respiratory depression;Extubation time;

Countries

China

Contacts

Public ContactLiQunCheng

Shanghai Children's Medical Center, Shanghai Jiao Tong University School of Medicine

546106227@qq.com+86 180 7009 7862

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026