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Remidazolam prevents recovery period of general anesthesia after laparoscopic hernia surgery in children clinical study of restlessness

Remidazolam prevents recovery period of general anesthesia after laparoscopic hernia surgery in children clinical study of restlessness

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000038840
Enrollment
Unknown
Registered
2020-10-05
Start date
2020-10-01
Completion date
Unknown
Last updated
2021-01-05

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

Conditions

Children's restlessness after general anesthesia

Interventions

control group:Rimazollam group
group R: Rimazolom 0.1 mg / kg i.v

Sponsors

Affiliated Hospital of Guangdong Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Years to 9 Years

Inclusion criteria

Inclusion criteria: (1) Laparoscopic hernia surgery under general anesthesia in 3-9 years old children; (2) ASA grade 1-2; (3) Body mass index 18-23; (4) The family members of the children voluntarily participated and signed the informed consent.

Exclusion criteria

Exclusion criteria: (1) Known or suspected to be allergic or contraindicated to various components of the study drug or other opioids; (2) Analgesic, sedative, antiemetic and anti pruritus drugs were used 24 hours before operation; (3) Shock or coma; (4) Patients with bronchial asthma or respiratory depression; (5) Brain injury, intracranial injury or the presence of increased intracranial pressure; (6) There are chronic pain, long-term use of analgesics, psychiatric drugs (including opioids, NSAIDs, sedatives, antidepressants, etc.), alcohol abuse, drug abuse and addicts; (7) Liver and kidney function: ALT and / or ast exceed 1.5 times of the upper limit of medical reference value creatinine or urea nitrogen beyond the normal range; (8) Severe arrhythmia, cardiac insufficiency (NYHA grade >= III), unstable heart angina pectoris, acute myocardial infarction in recent 6 months, no regular antihypertensive treatment or blood pressure control; Patients with poor performance (SBP >= 160 mmHg and / or DBP>= 100 mmHg) or (SBP <= 90 mmHg and / or DBP <= 60 mmHg); (9) Those who cannot give full informed consent due to mental disorders and cannot express their wishes correctly; (10) Patients with a known history of neurological abnormalities, such as seizures; (11) Patients who have received any other trial drugs within 3 months before enrollment; (12) The researchers judged that the subjects' compliance was not good and could not strictly implement regime.

Design outcomes

Primary

MeasureTime frame
Emergence agitation score;

Countries

China

Contacts

Public ContactGu Xiaoxia

Affiliated Hospital of Guangdong Medical University

343251863@qq.com+86 13729030217

Outcome results

None listed

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