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Clinical study of remazolam combined with nalbuphine for painless gastrointestinal endoscopy

Clinical study of remazolam combined with nalbuphine for painless gastrointestinal endoscopy

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100043228
Enrollment
Unknown
Registered
2021-02-09
Start date
2021-03-01
Completion date
Unknown
Last updated
2021-06-07

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

Conditions

Gastrointestinal diseases

Interventions

Observation Group:Remazolam combined with nalbuphine
Control Group:Remazolam combined with propofol

Sponsors

The Affiliated Hospital of Shaoxing university
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) ASA class I-III agreed to participate in the trial and signed a written informed consent; (2) There was no history of long-term use of opioids; (3) No neuromuscular diseases, no severe liver and kidney diseases, no cardiovascular diseases (severe bradycardia), no cardiac dysfunction, no history of bronchial asthma and preoperative hypercapnia; (4) 50 kg <= body weight <= 100 kg, body mass index (BMI) 18-27.

Exclusion criteria

Exclusion criteria: (1) Patients with allergic reactions to the drugs used in this study, such as remazolam toluenesulfonate, naborphine and its components; (2) Acute respiratory infection; (3) Snoring, head and neck movement limitation, neck surgery history and other suspicious difficult airway; (4) Participants in other clinical trials; (5) Patients with chronic pain, neurological or psychiatric disorders, long-term use of sedatives, antipsychotics and analgesics.

Design outcomes

Primary

MeasureTime frame
Recovery time;

Secondary

MeasureTime frame
MMSE score;Operation time;Doctor and patient satisfaction;

Countries

China

Contacts

Public ContactNianping Chen

The Affiliated Hospital of Shaoxing university

sxcnp@126.com+86 575-88293778

Outcome results

None listed

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