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A study on the interaction of oxycodone combined with sufentanil during anesthesia induction and tracheal intubation for laparoscopic surgery in women

A study on the interaction of oxycodone combined with sufentanil during anesthesia induction and tracheal intubation for laparoscopic surgery in women

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500105078
Enrollment
Unknown
Registered
2025-06-27
Start date
2025-05-02
Completion date
Unknown
Last updated
2025-06-30

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

Conditions

Laparoscopic surgery requiring tracheal intubation

Interventions

Oxycodone group(Group O):Taking 0.25mg/kg of oxycodone as the starting dose, a 20% increase in the maximum values of MAP and/or HR within 3 minutes of tracheal intubation compared with the baseline va
Sufentanil Group (Group S):The initial dose of sufentanil is 0.4ug/kg. If the tracheal intubation response is positive, sufentanil for the next patient will be increased to 1.25 times the original dos
Oxycodone and sufentanil combination Group 1 (OS1 group):In the OS1 group, the starting dose was 0.25× sufentanil ED50+0.75× oxycodone ED50. The sufentanil dose was fixed and the oxycodone dose was ch
Oxycodone and sufentanil combination Group 2 (OS2 group):In the OS2 group, the starting dose was 0.5× sufentanil ED50+0.5× oxycodone ED50. The sufentanil dose was fixed and the oxycodone dose was chan
Oxycodone a

Sponsors

The Third Affiliated Hospital of Zhengzhou University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: 1. Adult female patients aged 18 to 45 years who require oral tracheal intubation in the operating room and are scheduled for elective general anesthesia laparoscopic surgery; 2. with ASA classification of grade I or II; 3. The patient or the authorized person has signed the informed consent form. 4. Body Mass Index: 18 - 28 kg/m² ; 5. There were no preoperative predicted difficult airways, small mandibles, limited neck mobility, congenital nasal abnormalities, etc. 6. No severe malnutrition, abnormal liver or kidney function; no severe cardiovascular disease; no severe respiratory system infection. 7. No allergy to opioid drugs.

Exclusion criteria

Exclusion criteria: 1. The nasal intubation technique should be adopted, with multiple intubations and an intubation time of more than 30 seconds; 2. Preoperative assessment of difficult airway, small mandible, limited neck movement, congenital nasal abnormalities, etc.; 3. Allergic to opioid drugs and general anesthetic drugs; 4. Long-term use of anesthetic drugs or opioid drugs; 5. Severe respiratory infectious diseases; 6. Severe malnutrition, abnormal liver and kidney function, severe cardiovascular diseases.

Design outcomes

Primary

MeasureTime frame
Cardiovascular changes in the patient during intubation;

Secondary

MeasureTime frame
The patient's reaction during intubation;

Countries

China

Contacts

Public ContactYuxia Wang

The Third Affiliated Hospital of Zhengzhou University, Erqi District, Zhengzhou City, Henan Province

wyxwl@zzu.edu.cn+86 182 3710 6608

Outcome results

None listed

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