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

Sponsor
Yongtao Sun
Study ID
NCT06953570
Status
Not Yet Recruiting

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Conditions

  • Frailty
  • Laparoscopic Gastrointestinal Surgery
  • PCIA

Eligibility Criteria

Sex
ALL
Age
65 Years - N/A
Healthy Volunteers
Not accepted

Study Details

This study aims to investigate the ED50 and ED95 of nalbuphine combined with dexmedetomidine in patient-controlled intravenous analgesia (PCIA) for elderly patients with different degrees of frailty, as well as their analgesic effects and complications. The results of this study can provide safe and effective dosage guidance for postoperative analgesia in frail patients, help optimize analgesic regimens, reduce the risk of complications, and improve the quality of postoperative recovery.

Key Dates

First listed
May 1, 2025
Start date
Oct 1, 2025
Status verified
Apr 2025
Primary completion
Oct 1, 2026
Completion
Oct 10, 2026

Study Design

Enrollment
120 participants (estimated)

Arms

  • Arm: frailty group（F）（mFI≧0.27）
    The initial PCA pump formulation for the first patient was set as: dexmedetomidine 2 μg/kg, nalbuphine 1 mg/kg, ondansetron 16 mg, diluted to 100 ml with normal saline. The study employed a modified Dixon up-and-down sequential method, with an initial dose of nalbuphine at 1 mg/kg. A resting Visual Analog Scale (VAS) score \> 3 within 24 hours postoperatively was defined as a negative response. If a negative response occurred, the dose of nalbuphine for the next patient in the same group would be increased by 0.1 mg/kg (e.g., 1.0 → 1.1 mg/kg). Conversely, if a positive response occurred, the dose for the next patient would be decreased by 0.1 mg/kg (e.g., 1.0 → 0.9 mg/kg). The trial was terminated when eight consecutive negative-to-positive inflection points were observed.
  • Arm: pre-frailty group (P)(0<mFI<0.27)
    The initial PCA pump formulation for the first patient was set as: dexmedetomidine 2 μg/kg, nalbuphine 1 mg/kg, ondansetron 16 mg, diluted to 100 ml with normal saline. The study employed a modified Dixon up-and-down sequential method, with an initial dose of nalbuphine at 1 mg/kg. A resting Visual Analog Scale (VAS) score \> 3 within 24 hours postoperatively was defined as a negative response. If a negative response occurred, the dose of nalbuphine for the next patient in the same group would be increased by 0.1 mg/kg (e.g., 1.0 → 1.1 mg/kg). Conversely, if a positive response occurred, the dose for the next patient would be decreased by 0.1 mg/kg (e.g., 1.0 → 0.9 mg/kg). The trial was terminated when eight consecutive negative-to-positive inflection points were observed.
  • Arm: non-frailty group (N)（mFI=0）
    The initial PCA pump formulation for the first patient was set as: dexmedetomidine 2 μg/kg, nalbuphine 1 mg/kg, ondansetron 16 mg, diluted to 100 ml with normal saline. The study employed a modified Dixon up-and-down sequential method, with an initial dose of nalbuphine at 1 mg/kg. A resting Visual Analog Scale (VAS) score \> 3 within 24 hours postoperatively was defined as a negative response. If a negative response occurred, the dose of nalbuphine for the next patient in the same group would be increased by 0.1 mg/kg (e.g., 1.0 → 1.1 mg/kg). Conversely, if a positive response occurred, the dose for the next patient would be decreased by 0.1 mg/kg (e.g., 1.0 → 0.9 mg/kg). The trial was terminated when eight consecutive negative-to-positive inflection points were observed.

Primary Outcome Measure

Median Effective Dose (ED50) of Nalbuphine Based on Visual Analogue Scale (VAS) for Resting Pain at 24 Hours After Surgery [ Time Frame: Within 24 hours after the end of surgery ]

Central Contacts

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