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Comparison of safety and efficacy of propofol alone or combined with oxycodone and sufentanil for anesthesia in hysteroscopic surgery: a randomized, double-blind, controlled trial

Comparison of safety and efficacy of propofol alone or combined with oxycodone and sufentanil for anesthesia in hysteroscopic surgery: a randomized, double-blind, controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600120534
Enrollment
Unknown
Registered
2026-03-16
Start date
2026-03-16
Completion date
Unknown
Last updated
2026-03-23

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

Conditions

Hysteroscopic surgery

Interventions

Propofol group (Group P):a. Induction: The initial target concentration of propofol is 3.0 µg/ml. b. Maintenance: Adjust the target concentration to maintain BIS between 40-60. If BIS > 60 and there i
if BIS 60 with body movement, increase by 0.5 µg/mL
if BIS 60 and there is body movement, increase by 0.5 µg/ml
if BIS < 40 and there is no body movement, decrease the target concentration
if the patients BIS < 40 and there is body movement, add sufentanil 0.05 ug/kg.

Sponsors

Bo'ai Hospital of Zhongshan City
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 50 Years

Inclusion criteria

Inclusion criteria: 1.Aged 18-50 years old; 2.ASA classification ?-?; 3.Scheduled to undergo elective hysteroscopic surgery (such as endometrial polypectomy, intrauterine adhesion separation, etc.), with the expected duration of the surgery<=30 minutes; 4.Patients and their families are informed and consent, and have signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1.Those who are allergic to propofol, oliceridine, sufentanil or their excipients; 2.Those with severe cardiopulmonary diseases (such as heart failure, acute exacerbation of chronic obstructive pulmonary disease), hepatic or renal insufficiency (Child-Pugh class B or above); 3.Those with a history of opioid abuse or dependence; 4.Those who have used analgesics or antiemetics within 24 hours before surgery; 5.Pregnant or lactating women, or those with mental illness who cannot cooperate with researchers.

Design outcomes

Primary

MeasureTime frame
Composite endpoint: The proportion of patients who experienced at least one of the following predefined clinically relevant adverse events from the time of surgery to 24 hours after surgery: 1. A decrease in systolic blood pressure of 20% or more, or a mean arterial pressure (MAP) of less than 65 mmHg, or hemodynamic instability requiring drug intervention (e.g., the use of ephedrine, atropine, etc.). 2. Clinically significant respiratory depression,etc.;

Secondary

MeasureTime frame
Incidence rate of hypotension;Incidence rate of respiratory depression;Incidence rate of PONV;Incidence rate of injection pain;Total dosage of propofol;Induction time;Incidence of intraoperative body movement and number of rescue attempts;Percentage of time BIS is within the target range;Surgeon's satisfaction;Wake-up time;Time to recovery of orientation;PACU stay time;VAS pain score 30 minutes after surgery;Overall satisfaction score at discharge;Postoperative 24-hour QoR-15 Recovery Quality Score;

Countries

China

Contacts

Public ContactHuanlong Xie

Bo'ai Hospital of Zhongshan City

3405187006@qq.com+86 199 2595 6233

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Apr 3, 2026