Hysterectomy Clinical Trials

Clinical trials related to Hysterectomy Procedure

Effect of Equivalent Dose of Oxycodone or Tegileridine on Patients Undergoing Gynecological Laparoscopic Hysterectomy

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

This randomized, double-blind, controlled study aims to evaluate the efficacy and safety of Tegileridine or Oxycodone for postoperative analgesia in patients undergoing Total Laparoscopic Hysterectomy(TLH). Subjects will be randomly assigned to receive an equivalent dose of intravenous Tegileridine or Oxycodone as part of a standard postoperative analgesia regimen. All patients will have access to rescue opioid analgesia according to the protocol. The primary objective is to determine if a single application of an equivalent dose of Tegileridine or Oxycodone can keep VAS scores at or below 3 during the anesthesia recovery phase. The secondary objectives are to compare cumulative opioid consumption within 48 hours postoperatively, time to first rescue analgesia, and the incidence rate of adverse events, such as nausea, vomiting, sedation, respiratory depression, pruritus, and constipation. Safety will be monitored throughout the study via predefined stop-and-report procedures. The study results will evaluate whether teglitazide provides a more effective, better-tolerated analgesic regimen for patients undergoing total laparoscopic hysterectomy.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• Patients undergoing laparoscopic total abdominal hysterectomy with single-lumen endotracheal tube placement under general anaesthesia.

• Females aged 18-65 years with a BMI of 18-28 kg/m²;

• Normal mouth opening and head/neck mobility;

• Preoperative American Society of Anesthesiologists (ASA) physical status classification of I-III and Mallampati airway classification of I or II;

• Patients must also be scheduled for postoperative analgesia and have signed an informed consent form.

Locations
Other Locations
China
Department of Anesthesiology,the Second Affiliated Hospital of Hainan Medical University
RECRUITING
Haikou
Contact Information
Primary
Dr.chen
Dr_chen1699@163.com
8617378224751
Time Frame
Start Date: 2025-12-20
Estimated Completion Date: 2026-02-20
Participants
Target number of participants: 92
Treatments
Experimental: Tegileridine(T group)
Around 20 minutes before the end of the operation, patients in the T group were given 0.01 mg/kg of Tegileridine(dissolved in 10 ml of 0.9% sodium chloride injection solution. This was administered via continuous infusion at a rate of 60 ml/h).
Experimental: Oxycodone(O group)
Around 20 minutes before the end of the operation, patients in the O group were given 0.06 mg/kg of Oxycodone(dissolved in 10 ml of 0.9% sodium chloride injection solution. This was administered via continuous infusion at a rate of 60 ml/h).
Related Therapeutic Areas
Sponsors
Collaborators: Second Affiliated Hospital of Hainan Medical College
Leads: Xin Chen

This content was sourced from clinicaltrials.gov

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