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Clinical trial of Remimazolam for painless gastrointestinal tumor screening in elderly patients with hypertension:A prospective multicenter randomized study

Clinical trial of Remimazolam for painless gastrointestinal tumor screening in elderly patients with hypertension

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400083757
Enrollment
Unknown
Registered
2024-04-30
Start date
2024-05-01
Completion date
Unknown
Last updated
2024-05-06

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

Conditions

Elderly patients with hypertension,Gastrointestinal tumor screening

Interventions

Group remimazolam:Sufentanil 0.1 µg/kg + remazolam [induction: 0.3 mg/kg, maintenance: 0.2-1 mg/kg/h]
Flumazenil 2 ml/0.2 mg [given after stopping the remazolam and repeated every 2 min until the patient awakens, with the maximum dose not exceeding 1 mg]
Group propofol:Sufentanil 0.1 µg/kg + propofol [induction 1.5 mg/kg, maintenance: 2-6 mg/kg/h (0-1 µg/kg/min)]
Saline 2 ml [given after cessation of propofol, repeated every 2 min until the patient awoke]

Sponsors

Sichuan Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) Elderly hypertensive patients who were to undergo painless gastroenteroscopy; (2) Age 65-75 years; (3) Weight 50-70 kg; (4) ASA classification of II-III and cardiac function class I-II; (5) History of primary hypertension with blood pressure controlled within 160/90mmHg after standardized treatment.

Exclusion criteria

Exclusion criteria: (1) Patients who refused to participate in the trial; (2) Patients whose hypertension is not treated with regular medication; (3) Patients with a history of severe cardiac, cerebral, pulmonary, hepatic, renal and metabolic diseases; (4) Those with a previous history of recovery from abnormal surgical anesthesia; (5) Electrocardiogram suggestive of a heart rate <50 beats/min; (6) History of acute inflammation of the respiratory tract within 2 weeks with no cure; (7) Those with neuromuscular system diseases and psychiatric diseases; (8) Patients with anemia; (9) Persons with suspected abuse of narcotic analgesics or sedatives; (10) Persons who are predicted to have or have had a difficult airway; (11) Persons with known hypersensitivity to emulsions, benzodiazepines, and opioids; (12) Those who are uncooperative and unable to communicate.

Design outcomes

Primary

MeasureTime frame
Incidence of Hypotension;Cardiac function indices [cardiac index (CI), left ventricular output (CO), peripheral vascular resistance (SVR), pulse pressure variability (PPV), perfusion index (PI)] ;

Secondary

MeasureTime frame
Incidence of Respiratory Depression;Intraoperative adverse effects;Dosage of Sedative drug;Onset time of sedative drugs; Awakening time of patient; Satisfaction of patient and endoscopist;postoperative adverse effects;

Countries

China

Contacts

Public ContactShu Jinjun

Sichuan Cancer Hospital

shuhu918@163.com+86 135 5020 7607

Outcome results

None listed

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