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Comparison of respiratory adverse events of oliceridine, esketamine and sufentanil in hysteroscopy :a prospective, randomized, controlled trial

Comparison of respiratory adverse events of oliceridine, esketamine and sufentanil in hysteroscopy :a prospective, randomized, controlled trial

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500102673
Enrollment
Unknown
Registered
2025-05-19
Start date
2025-05-20
Completion date
Unknown
Last updated
2025-05-26

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

Conditions

Endometrial polyps

Interventions

Oliceridine Group:The initial dose of oliceridine administered intravenously is 30ug/kg. As before, all patients was given target-controlled infusion of propofol to maintain BIS values between 40-60
conversely, if the patient succeeded, the next patient received a reduction of one incremental dose. The interval dose was set at 6 µg/kg .
Esketamine Group:The experimental procedure is the same as that of oliceridine. Based on previous research and experience, the initial dose of the Esketamine group is set at 0.25mg/kg,.The interval do
Sufentanil Group:The experimental procedure is the same as that of oliceridine. Based on previous research and experience, the initial dose of the Sufentanil group is set at 0.15µg/kg,.The interval d
Oliceridine Group:Before the surgery , all patients was given target-controlled infusion of p

Sponsors

The First Affiliated Hospital of Xiamen University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: (1)All patients underwent elective daytime hysteroscopic endometrial polypectomy surgery, with an estimated surgery time of = 20 minutes. (2)Age is between 18 and 64 years old, and American Society of Anesthesiologists (ASA) physical status of I or II. (3)Patients have normal communication skills and the ability to cooperate. (4)BMI is between18.5 and 24.0 and weight is less than 65kg.

Exclusion criteria

Exclusion criteria: (1) Individuals who are allergic to any medication during surgery; (2) History of alcohol abuse, opioid and ketamine abuse before surgery; (3) Mallampati airway grade is equal or greater than 3 or patient have severe respiratory diseases such as OSAS, moderate to severe restrictive, obstructive ventilation dysfunction, asthma, and pulmonary arterial hypertension; (4) Serious heart, liver, brain, and kidney diseases, such as severe hypertension (systolic blood pressure = 160mmHg or diastolic blood pressure = 100mmHg), large vessel aneurysms, cerebral hemorrhage, and other important organ damage; (5) Electrocardiogram indicates bradycardia (HR<60 beats/minute), second or third degree atrioventricular block, QT interval prolongation, etc; (6) History of gastrointestinal surgery (excluding resection of 1-2cm gastrointestinal polyps and removal of small gastrointestinal polyps less than 0.5 cm using biopsy forceps, other polyp surgery histories will not be included in this study), history of gastroesophageal reflux (patients with self-reported acid reflux and heartburn symptoms and patients diagnosed by gastroscopy), and digestive tract obstruction; (7) Individuals with mental illnesses, communication difficulties, and inability to cooperate. (8) Patients who refuse to cooperate or choose to withdraw from the study due to personal reasons; (9) Those who need to change the surgical method due to surgical requirements; (10) Serious adverse events unrelated to the study drug that occur during the research process and cannot be included in the study or unexpected events; (11) Patients who are lost to follow-up due to various reasons; (12) Others.

Design outcomes

Primary

MeasureTime frame
Respiratory depression ;Hypoxemia;Respiration Rate;

Secondary

MeasureTime frame
mean arterial pressure;PetCO2;heart rate;

Countries

China

Contacts

Public ContactYE Linyang

The First Affiliated Hospital of Xiamen University

1927484131@qq.com+86 136 9501 6899

Outcome results

None listed

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