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Search / Trial NCT06953570

Impact of Frailty on Nalbuphine Dose for Postoperative Analgesia in Elderly Patients Undergoing Laparoscopic GI Surgery

Launched by YONGTAO SUN · Apr 23, 2025

Trial Information

Current as of June 26, 2025

Not yet recruiting

Keywords

Nalbuphine Ed50 Pcia Laparoscopic Gastrointestinal Surgery Frailty

ClinConnect Summary

This clinical trial is studying how different levels of frailty in elderly patients affect the dosage of a pain medication called nalbuphine when used after laparoscopic gastrointestinal (GI) surgery. The goal is to find the right amount of nalbuphine that, when combined with another medication, provides effective pain relief while minimizing complications. By understanding how frailty impacts pain management, the researchers hope to improve recovery for older adults after surgery.

To be eligible for this study, participants must be at least 65 years old, plan to have elective GI surgery with a hospital stay of three days or more, and have a body mass index (BMI) between 18.5 and 30. The study will not include patients with severe health issues, recent treatments like chemotherapy, or those who have participated in other clinical trials recently. If eligible, participants can expect to receive personalized pain management after their surgery while helping researchers gather important information that could enhance care for frail patients in the future.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 1. Patients who plan to undergo elective gastrointestinal surgery and are expected to stay in hospital for ≥3 days after surgery \[except abdominal perineal combined with radical resection of rectal cancer (MILES)\];
  • 2. ASA grade I-Ⅳ;
  • 3. Age ≥65 years (2);
  • 4. 18.5 kg/m²≤BMI\<30 kg/m²;
  • 5. Sign the informed consent form.
  • Exclusion Criteria:
  • 1. Severe cardiopulmonary, liver, kidney and coagulation dysfunction
  • 2. Chemotherapy and radiotherapy were administered 1 month before surgery, and sedatives, antiemetic or antipruritic drugs were administered 24 hours before surgery
  • 3. History of drug abuse, chronic pain, mental illness, or allergy to the drugs used in this study
  • 4. Plan postoperative intubation or transfer to ICU;
  • 5. Participated in other clinical studies within the past 3 months.

About Yongtao Sun

Yongtao Sun is a distinguished clinical trial sponsor recognized for advancing medical research through innovative study designs and rigorous methodologies. With a commitment to enhancing patient care and outcomes, Yongtao Sun leads initiatives across various therapeutic areas, collaborating with healthcare professionals and institutions to ensure the highest standards of ethical conduct and scientific integrity. The organization is dedicated to fostering a collaborative environment that accelerates the development of safe and effective therapies, ultimately contributing to the improvement of global health.

Locations

Patients applied

0 patients applied

Trial Officials

Yongtao Sun, Ph.D.

Study Chair

Qianfoshan Hospital, The First Hospital affiliated of Shandong First Medical University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported