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Clinical Effect Evaluation of Oliceridine Injection versus Sufentanil Injection in General Anesthesia for Holmium Laser Lithotripsy of Ureteral Calculi: A Randomized Controlled Trial Focusing on Postoperative Sleep Quality, Analgesia, and Opioid Side Effects of Patients

Clinical Effect Evaluation of Oliceridine Injection versus Sufentanil Injection in General Anesthesia for Holmium Laser Lithotripsy of Ureteral Calculi: A Randomized Controlled Trial Focusing on Postoperative Sleep Quality, Analgesia, and Opioid Side Effects of Patients

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500109236
Enrollment
Unknown
Registered
2025-09-16
Start date
2025-09-22
Completion date
Unknown
Last updated
2025-09-22

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

Conditions

Ureteral calculi

Interventions

Experimental group:Induction of anesthesia: a loading dose of 1.5 mg oliceridine (bolus time >1 minute)

Sponsors

Mengcheng County First 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; 2. ASA classification I-II; 3.BMI18.5-28 4. Patients scheduled for elective holmium laser lithotripsy via ureteroscopy; 5.The start time of surgery is all before 12:00. 6. Signed informed consent form.

Exclusion criteria

Exclusion criteria: 1. Known allergy to oxycodone, sufentanil, or other opioids; 2. Severe dysfunction of vital organs such as heart, liver, or kidneys; 3. Severe respiratory diseases (e.g., COPD GOLD III-IV, uncontrolled OSA); 4. Long-term use of opioids (>3 months), history of drug abuse, or use of potent opioids within 24 hours before surgery; 5. Severe sleep disorders or diagnosed sleep apnea syndrome (untreated) before surgery; 6. Mental illness that prevents cooperation with assessment; 7. Pregnant or breastfeeding women; 8. Investigators deem the individual unsuitable for participation in the study.

Design outcomes

Primary

MeasureTime frame
Subjective sleep quality (sleep diary) score;

Secondary

MeasureTime frame
Patient satisfaction;Hospitalization period;Postoperative pain;Postoperative nausea and vomiting;Respiratory depression;The incidence of coughing reflex during anesthesia induction;Intraoperative hemodynamic stability;The time of the first postoperative exhaust/defecation;Self-Rating Anxiety?Scale;Self-rating depression scale;Heart rate variability ;Pittsburgh Sleep Quality Index;S100 Calcium Binding Protein B;Melatonin;Neuron-specific enolase(NSE);Iridin;Brain-derived neurotrophic factor;Interleukin-6;

Countries

People's Republic of China

Contacts

Public ContactZhangMeng

Anhui Province Mengcheng County No.1 People's Hospital

anhui-1983@163.com+86 181 5673 5516

Outcome results

None listed

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