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Effect of Earplugs on Propofol Consumption and Peri-procedural Outcomes in Patients Undergoing Painless Gastrointestinal Endoscopy: A Randomized Controlled Trial

Effect of Earplugs on Propofol Consumption and Peri-procedural Outcomes in Patients Undergoing Painless Gastrointestinal Endoscopy: A Randomized Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600115971
Enrollment
Unknown
Registered
2026-01-04
Start date
2026-01-05
Completion date
Unknown
Last updated
2026-01-05

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

Conditions

None listed

Interventions

Control:Standard care, no use of earplugs
Intervention group:Using earplugs

Sponsors

The First Affiliated Hospital of Soochow University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1.Adults aged 18–80 yr, BMI < 30 kg·m^2; 2.ASA physical status I–II; 3.Scheduled for elective painless gastroscopy, colonoscopy, or combined procedure;

Exclusion criteria

Exclusion criteria: 1.Endoscopic contraindication or refusal of sedation; 2.Hearing impairment or inability to wear earplugs; 3.Known allergy to propofol or any component of the anesthetic regimen, or any other major anesthetic risk; 4.Uncontrolled life-threatening cardiovascular or respiratory disease: acute coronary syndrome, severe uncontrolled hypertension (SBP >= 180 mmHg or DBP >= 110 mmHg), significant arrhythmia, decompensated heart failure, acute respiratory infection, acute asthma exacerbation, active bleeding, liver failure (Child–Pugh class C), severe anaemia (Hb < 60 g/ L), gastrointestinal obstruction with gastric stasis, untreated obstructive sleep apnoea; 5.Chronic use of sedatives or opioids; 6.Inability to communicate or give informed consent, or absence of an escort/guardian;

Design outcomes

Primary

MeasureTime frame
Total dose of propofol;

Secondary

MeasureTime frame
Patient satisfaction;Recovery time;Fatigue score;Hypotension event;Desaturation;

Countries

China

Contacts

Public ContactKe Peng

The First Affiliated Hospital of Soochow University

pengke0422@163.com+86 512 6778 0156

Outcome results

None listed

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