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Clinical study on the efficacy and safety of Taglidine fumarate injection for postoperative analgesia in patients undergoing radical resection of abdominal colorectal cancer

Clinical study on the efficacy and safety of Taglidine fumarate injection for postoperative analgesia in patients undergoing radical resection of abdominal colorectal cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500108479
Enrollment
Unknown
Registered
2025-09-01
Start date
2025-09-15
Completion date
Unknown
Last updated
2025-09-08

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

Conditions

Colorectal cancer

Interventions

Control group:PCIA: Sufentanil 150 µ g+ tropane 5mg+0.9%NS147ml, initial 5 µ g, additional 1ml each time, locked for 10 minutes, continuous 3ml/h
Experimental Group 1:PCIA: Taigilidine 7.5mg+ Tropane 5mg+0.9%NS142.5ml, initial 0.75mg, additional 1ml each time, locked for 10 minutes, continuous 3ml/h
Experimental Group 2:PCIA: Taigilidine 7.5mg+ Tropane 5mg+0.9%NS142.5ml, initial 1mg, additional 1ml each time, locked for 10 minutes, continuous 3ml/h

Sponsors

Mianyang 404 Hospital (The First People's Hospital Of Mianyang)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
19 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1.Patients aged 19 to 65 who are scheduled to undergo radical resection of abdominal colorectal cancer under general anesthesia; 2.No gender restrictions; 3.American Society of Anesthesiology (ASA) classification I-III; 4.BMI: 18-32kg/m^2; 5.Patients who can cooperate and correctly understand Chinese and express their intentions; 6.Patients who agreed to the trial protocol and signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1.Patients who do not agree to conduct experimental research; 2.Patients with ASA grade greater than grade III; 3.Known or suspected gastrointestinal obstruction, including patients with paralytic ileus; 4.Patients with acute or severe bronchial asthma in the absence of vital sign monitoring or life resuscitation equipment; 5.Patients with severe liver dysfunction; 6.Patients with abnormal mental states; 7.Patients who are allergic to any component of opioid drugs or investigational drugs; 8.Patients with severe respiratory depression, such as those with an oxygen saturation level below 90%.

Design outcomes

Primary

MeasureTime frame
The VAS score of the patient at rest 30 minutes after the tracheal tube was removed.;

Secondary

MeasureTime frame
VAS scores at rest and passive turning at 6 hours, 12 hours, 24 hours and 48 hours after the operation;The dosage of remifentanil and sufentanil during the operation;The use of remedial analgesic drugs within 48 hours after the operation;The number of compressions of the PCIA within 48 hours after the operation;The number of times sleep was interrupted due to pain on the night of the surgery;Complications such as nauseas and vomiting;

Countries

China

Contacts

Public ContactWang Jiao

Mianyang 404 Hospital (The First People's Hospital Of Mianyang)

972628456@qq.com+86 158 0848 0267

Outcome results

None listed

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