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Application of low-dose remifentanil combined with remifentanil in moderate sedation gastroscopy of obese patients

Application of low-dose remifentanil combined with remifentanil in moderate sedation gastroscopy of obese patients

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500101384
Enrollment
Unknown
Registered
2025-04-24
Start date
2024-08-13
Completion date
Unknown
Last updated
2025-04-28

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

Conditions

None

Interventions

Experimental group:First, slowly inject 0.04-0.05mg/kg of remifentanil according to the corrected body weight, and then intravenously inject 1ug/kg of remifentanil according to the corrected body weig
Control group:First inject an equivalent dose of placebo, then slowly intravenously inject remifentanil 1ug/kg

Sponsors

Xuzhou Medical University Affiliated Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
16 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) Age range from 16 to 65 years old; (2) ASA classification II-III; (3)BMI>=30 kg/m^2; (4) Accept painless gastroscopy examination; (5) It is expected that the gastroscopy operation time will not exceed 15 minutes; (6) Those who voluntarily cooperate with this study.

Exclusion criteria

Exclusion criteria: (1) Complicated endoscopic techniques (such as cholangiopancreatography, endoscopic ultrasound, endoscopic mucosal resection, endoscopic submucosal dissection, peroral endoscopic myotomy, etc.) should be performed; (2) SpO2=180mmHg and/or diastolic blood pressure >=110mmHg after admission; (3) confirmed diagnosis of obstructive sleep apnea syndrome; (4) those who are known to be allergic to or have contraindications to opioids, benzodiazepines and their rescue drugs; (5) severe respiratory and cardiovascular diseases, liver and kidney dysfunction and coagulation dysfunction; (6) patients with mental disorders, long-term use of psychotropic drugs and cognitive impairment; (7) having a history of drug abuse, drug abuse or alcohol abuse within 2 years before the screening period; (8) taking benzodiazepines daily within one month or intermittently within the last three months;

Design outcomes

Primary

MeasureTime frame
The success rate of endoscopic placement without any response (when the patient experiences dry vomiting, coughing, or body movement reaction during or within 1 minute of endoscopic placement);

Secondary

MeasureTime frame
90%<SpO2<95% and SpO2<90% incidence rates;Additional frequency and total amount of remifentanil;Patient satisfaction;The satisfaction of endoscopists;Duration of gastroscopy examination;Wake-up time;Departure time from the recovery room;

Countries

China

Contacts

Public ContactLianyi Zhang/Liu Su

Xuzhou Medical University Affiliated Hospital

qqlyly@126.com+86 158 9523 8010

Outcome results

None listed

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