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Safety of remazolam combined with afentanil for general anesthesia in patients undergoing endoscopic submucosal tumor resection: a single-center, randomized, case-control study

Safety of remazolam combined with afentanil for general anesthesia in patients undergoing endoscopic submucosal tumor resection: a single-center, randomized, case-control study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500097824
Enrollment
Unknown
Registered
2025-02-26
Start date
2025-03-01
Completion date
Unknown
Last updated
2025-03-03

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

Conditions

Gastroenteric tumor

Interventions

RS group:In the RS group, under the premise of 0.1ug/kg sufentanil analgesia, the dose of remazolam 10mg/kg/h was continuously pumped until the BIS value dropped to 40-60. Remazolam was continuously p
PS group:Under the premise of the same dose of sufentanil for analgesia, the PS group was continuously injected with propofol at a speed of 100mg/kg/h until the BIS value decreased to 40-60. Propofol
PS group:In the PA group, the equivalent dose of sufentanil (7ug/kg) was injected with propofol at a rate of 100mg/kg/h until the BIS value decreased to 40-60. Propofol was injected at a rate of 4-10m
RA group:After intravenous infusion of afentanil (7ug/kg) in RA group, ramazolam was pumped at a dose of 10mg/kg/h until BIS value dropped to 40-60. Remazolam was continuously pumped at a rate of 1-2m

Sponsors

Macheng People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) Age 18~65 years old, gender is not limited; (2) Those who are diagnosed with submucosal tumors after routine gastric and colonoscopy and plan to undergo elective submucosal tumor resection; (3) American Society of Anesthesiologists ASA grade I.-III; (4) BMI 18.5-30kg/m^2; (5) Informed consent, voluntarily participate in the trial, and sign the informed consent form.

Exclusion criteria

Exclusion criteria: (1) Subject clearly refuses to participate in this study; (2) Those with a history of severe heart, brain, lung, liver, kidney diseases and metabolic diseases; (3) Those with obvious contraindications to surgery; (4) Patients with acute inflammation of the respiratory tract within 2 weeks; (5) Systolic blood pressure > 180mmHg and/or diastolic blood pressure >110mmHg in patients with preoperative hypertension, or 90/60mmHg < patients with hypotension; (6) Those who are allergic to the drugs that may be used in the study; (7) Those with neuromuscular system diseases and mental diseases; (8) Those who are suspected of abusing narcotic analgesics or sedatives; (9) Those who predict that difficult airway may occur or have occurred; (10) Subjects who are considered inappropriate by the investigator to participate in this study.

Design outcomes

Primary

MeasureTime frame
Incidence of anesthesia-related adverse reactions;

Secondary

MeasureTime frame
Success rate of anesthesia;Patient and surgeon satisfaction;Postoperative quality of life score;

Countries

China

Contacts

Public ContactJiang Peiyan

Macheng People's Hospital

603416729@qq.com+86 136 3605 8846

Outcome results

None listed

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