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The effect of nalbuphine on respiratory function during digestive endoscopic procedures in high-risk population of obstructive sleep apnea

The effect of nalbuphine on respiratory function during digestive endoscopic procedures in high-risk population of obstructive sleep apnea

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500112819
Enrollment
Unknown
Registered
2025-11-19
Start date
2025-11-27
Completion date
Unknown
Last updated
2025-11-24

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

Conditions

Obstructive sleep spnea

Interventions

Nalbuphine Group:Before digestive endoscopy, nalbuphine is intravenously infused at a dose of 0.15 mg/kg, combined with propofol infused intravenously at a dose of 1.5 mg/kg for sedation.
Sufentanil Group:Before digestive endoscopy, sufentanil is intravenously infused at a dose of 0.1 µg/kg, combined with propofol infused intravenously at a dose of 1.5 mg/kg for sedation.

Sponsors

Tianjin Nankai Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1.Aged 18 years or older, regardless of gender; 2.Patients scheduled for elective painless digestive endoscopy; 3.American Society of Anesthesiologists (ASA) physical status classification I-III; 4.STOP-BANG score >=3 points; 5.Good patient compliance and ability to cooperate with treatment; 6.Patients provide informed consent and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1.Abnormal respiratory rate or SpO2 < 95% on room air during the screening period; 2.Patients with fever or acute upper respiratory tract infection within one week; 3.Patients allergic to the study drugs or dependent on opioid drugs; 4.Patients who have participated in other interventional clinical trials within 3 months before drug administration or plan to participate in such trials during the study period 5.Other conditions deemed unsuitable for inclusion in this trial by the investigator

Design outcomes

Primary

MeasureTime frame
Incidence of Respiratory-Related Adverse Events :;Hypoxemia: SpO2 15 seconds;Respiratory depression: RR 30 seconds;Apnea: Absence of thoracic movement > 20 seconds;

Secondary

MeasureTime frame
Intraoperative body movement episodes; Intraoperative propofol supplemental dose;Intraoperative manual/mask-assisted ventilation rate;Examination time; Time to full consciousness; Discharge time;Patient satisfaction evaluation for analgesia/anesthesia;

Countries

China

Contacts

Public ContactYu Jianbo

Tianjin Nankai Hospital

30717008@nankai.edu.cn+86 186 9808 7176

Outcome results

None listed

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