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Study for the Optimal Dose of Oliceridine Fumarate Injection Combined with Remimazolam for Painless Gastroscopy

Study for the Optimal Dose of Oliceridine Fumarate Injection Combined with Remimazolam for Painless Gastroscopy

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400093416
Enrollment
Unknown
Registered
2024-12-04
Start date
2024-09-23
Completion date
Unknown
Last updated
2024-12-09

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

Conditions

None

Interventions

one:The modified Dixon sequential method was used to conduct the trial, and the initial dose of oliceridine was set at 15 ug/kg, and the serial dose was 1.5 ug/kg. If the examination does not meet the
Otherwise, if it is negative, the next patient is reduced by 1 dose gradient, and the study is terminated when 7 crossovers occur (positive to negative).

Sponsors

Deyang People’s Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: Patients scheduled for painless gastroscopy; American Society of Anesthesiologists (ASA) class I-II; Aged 18~64 years old; Body mass index (BMI) 18~27 kg/m2;

Exclusion criteria

Exclusion criteria: difficult airway (modified Marhalanobis score grade IV.); poorly controlled hypertension (SBP>=160 mmHg and/or DBP>=100 mmHg); History of chronic use of anticonvulsant, sedative/alcohol, or opioid abuse; Mental disorders that are unable to express themselves properly; History of allergies to the drugs involved in the study, asthma attack period; Known or suspected gastrointestinal obstruction; Pregnancy or lactation; Combined with severe cardiovascular, renal and liver diseases;

Design outcomes

Primary

MeasureTime frame
Ocelidine dosage and effect;

Secondary

MeasureTime frame
Heart rate;Mean arterial pressure;oxygen saturation;patient satisfaction score and operator satisfaction score;Occurrence of complications;Sedation success rate;Gastroscopy operation time;Anesthesia recovery time;Time of patient discharge (The time the patient was sent out of the PACU);

Countries

China

Contacts

Public ContactXianjie Zhang

Deyang People’s Hospital

16177211@qq.com+86 139 8108 8319

Outcome results

None listed

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