Skip to content

Intravenous remimazolam vs intravenous midazolam for pre - operative sedation in children undergoing tonsillectomy and adenoidectomy: A randomized controlled study of peri - operative respiratory adverse events

Intravenous remimazolam vs intravenous midazolam for pre - operative sedation in children undergoing tonsillectomy and adenoidectomy: A randomized controlled study of peri - operative respiratory adverse events

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600127924
Enrollment
Unknown
Registered
2026-07-10
Start date
2026-08-01
Completion date
Unknown
Last updated
2026-07-13

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

Conditions

Enlarged tonsils or enlarged adenoids

Interventions

The group receiving midazolam intravenously:Intravenous injection of midazolam for sedation
The group receiving remimazolam intravenously:Intravenous injection of remimazolam for sedation

Sponsors

Children's Hospital of Chongqing Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Years to 12 Years

Inclusion criteria

Inclusion criteria: 1.Age range: 1 - 12 years old; 2.ASA I-II; 3.General anesthesia was administered for the elective surgery of tonsil and adenoid removal; 4.The guardian signs the informed consent; children over 8 years old sign the child version of the informed consent;

Exclusion criteria

Exclusion criteria: 1.Allergic to benzodiazepines or related excipients; 2.Severe cardiac and pulmonary dysfunction; 3.Acute respiratory tract infections in the past two weeks; 4.Congenital abnormal liver and kidney function; 5.Neuromuscular diseases, cerebral palsy, epilepsy; 6.Difficult airway; 7.Patients who are expected to require admission to the ICU after the surgery; 8.Participants in other intervention studies that may affect the outcome of this research; 9.Other circumstances that the researchers determined were not suitable for inclusion in the study;

Design outcomes

Primary

MeasureTime frame
Perioperative respiratory adverse events,PRAEs;

Secondary

MeasureTime frame
Separation score;Induction coordination;Degree of sedation;

Countries

China

Contacts

Public ContactLifei Liu

Children's Hospital of Chongqing Medical University

54099645@qq.com+86 23 6363 2143

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jul 23, 2026