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Efficacy and safety of remimazolam combined with afentanil for ERCP anesthesia in elderly patients with frailty: a single-center, randomized, parallel-controlled clinical trial.

Efficacy and safety of remimazolam combined with afentanil for ERCP anesthesia in elderly patients with frailty: a single-center, randomized, parallel-controlled clinical trial.

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400079414
Enrollment
Unknown
Registered
2024-01-03
Start date
2024-01-20
Completion date
Unknown
Last updated
2024-01-08

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

Conditions

None listed

Interventions

Group R :Group R received intravenous injection of remazolam 0.25mg/kg and continuous pump injection of remazolam 0.6-1.0mg ·kg-1·h-1
Group P:Group P was given propofol 1.5mg/kg intravenously and propofol 4~8mg·kg-1·h-1 intravenously continuously

Sponsors

General Hospital of Northern Theater Command
Lead Sponsor

Eligibility

Sex/Gender
All
Age
75 Years to 100 Years

Inclusion criteria

Inclusion criteria: (1) Age =75 years old; (2) ASA grade II-III, and Fried frailty phenotype was evaluated as frailty; (3) Patients with ERCP; (4) The anesthesia was monitored anesthesia without intubation (MAC); (5) Estimated operation time =3 hours; (6) Body mass index (BMI) =18 and < 30 kg/m2; (7) The basic cognitive function of the patients was evaluated before surgery, and the score of the simple mental State Examination Scale (MMSE) was =27 points; (8) Willing to sign informed consent and actively cooperate with clinical research.

Exclusion criteria

Exclusion criteria: (1) People who are known to be allergic to eggs or soy products, sedatives and analgesics; (2) Patients with contraindications to deep sedation/general anesthesia or who have a history of anesthesia accidents; (3) Unstable hemodynamic state: BP > 180/110mmHg; SBP 110 times/min or < 50 times/min; (4) History of severe respiratory diseases: obstructive sleep apnea syndrome, acute respiratory infection, acute episodes of chronic obstructive pulmonary disease, uncontrolled asthma, etc. (5) Severe liver insufficiency: Child-Pugh grade C or above; (6) Severe renal insufficiency: chronic renal failure requires dialysis; (7) History of stroke or other organic encephalopathy; (8) Patients with mental illness, long-term history of taking psychiatric drugs; (9)Severe anxiety and delirium before surgery (self-rating Anxiety Scale/Self-rating Depression Scale (SAS/SDS) assessment, requiring participants to score SAS < 50 and SDS < 53).

Design outcomes

Primary

MeasureTime frame
Incidence of hypotension;

Secondary

MeasureTime frame
Number of successful sedation cases;Remedy sedation ;Onset time;Recovery time;Exit time;Intraoperative vital signs monitoring;The number of intraoperative airway interventions;The dose of vasoactive drug used during operation;Other adverse reactions and surgery-related complications;

Countries

China

Contacts

Public ContactSong Dandan

General Hospital of Northern Theater Command

songdandan6@163.com+86 177 9099 3788

Outcome results

None listed

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