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Sedative effect and hemodynamics influence of intravenous remazolam benzosulfonate in painless gastroscopy of children

Sedative effect and hemodynamics influence of intravenous remazolam benzosulfonate in painless gastroscopy of children

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400085205
Enrollment
Unknown
Registered
2024-06-03
Start date
2024-06-04
Completion date
Unknown
Last updated
2024-07-08

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

Conditions

Gastroscopy for children

Interventions

Propofol group (Group P):Intravenous injection of fentanyl (1µg/kg) + propofol (2mg/kg)
Remazolam group (Group R):Intravenous injection of fentanyl (1µg/kg) + remazolam (0.2mg/kg)

Sponsors

The Second Hospital of Shandong University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
6 Years to 14 Years

Inclusion criteria

Inclusion criteria: (1) Pediatric gastroenterologists evaluate children requiring gastroscopy; (2) Aged 6 to 14 years old; (3) BMI 18-28kg/m2; (4) ASA grade I-II.

Exclusion criteria

Exclusion criteria: (1) Children (family members) who refuse to participate in the observation, do not cooperate, and cannot communicate; (2) Acute respiratory inflammation within 2 weeks and no cure; (3) Have a history of serious heart, brain, lung and metabolic diseases; (4) People with serious blood system diseases; (5) People with neuromuscular system diseases or mental diseases; (6) Abnormal liver and kidney function; (7) Evaluate children with difficult airway (Mallampati score level III or above) or those requiring tracheal intubation; (8) Those allergic to remazolam and propofol; (9) Participate in other drug clinical trials 3 months before inclusion in the study.

Design outcomes

Primary

MeasureTime frame
Sedation success rate;Mean arterial pressure;Pulse oxygen saturation;Heart rate;Respiratory rate;

Secondary

MeasureTime frame
Time of sedation onset;bispectral index;Time of recovery;Operating room exit time;

Countries

China

Contacts

Public ContactXie Kun

The Second Hospital of Shandong University

2277316289@qq.com+86 176 6008 5257

Outcome results

None listed

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