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

NCT06953570 | Not Yet Recruiting

• 1 other identifier: Nalbuphine
• Study Type: observational
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

PCIA; Frailty; Laparoscopic Gastrointestinal Surgery

Keywords

nalbuphine; ED50; PCIA; laparoscopic gastrointestinal surgery; frailty

Outcome Measures

Primary Outcomes (1)

• Median Effective Dose (ED50) of Nalbuphine Based on Visual Analogue Scale (VAS) for Resting Pain at 24 Hours After Surgery

  The median effective dose (ED50) of nalbuphine is defined as the dose at which 50% of patients report a resting Visual Analogue Scale (VAS) pain score of ≤3 within 24 hours postoperatively. The VAS is a 10-cm line scale ranging from 0 (no pain) to 10 (worst imaginable pain), evaluated at rest.

  Within 24 hours after the end of surgery

Secondary Outcomes (18)

• Dose of Nalbuphine Required to Achieve Resting VAS ≤3 in 95% of Patients Within 24 Hours After Surgery (ED95)

  Within 24 hours after the end of surgery

• Resting/Moving VAS (VASR/ VASM)

  At PACU discharge (immediately after anesthesia recovery), and at 6, 12, 18, 24, 36, and 48 hours after the end of surgery

• Ramsay Sedation Score (RASS)

  At PACU discharge (immediately after anesthesia recovery), and at 6, 12, 18, 24, 36, and 48 hours after the end of surgery

• Brinell comfort Scale (BCS)

  At PACU discharge (immediately after anesthesia recovery), and at 6, 12, 18, 24, 36, and 48 hours after the end of surgery

• Nausea and vomiting (PONV)

  At PACU discharge (immediately after anesthesia recovery), and at 6, 12, 18, 24, 36, and 48 hours after the end of surgery

Study Arms (3)

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.

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.

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.

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Elderly patients undergoing laparoscopic gastrointestinal surgery

You may qualify if:

• Patients who plan to undergo elective gastrointestinal surgery and are expected to stay in hospital for ≥3 days after surgery \[except abdominal perineal combined with radical resection of rectal cancer (MILES)\];
• ASA grade I-Ⅳ;
• Age ≥65 years (2);
• kg/m²≤BMI\<30 kg/m²;
• Sign the informed consent form.

You may not qualify if:

• Severe cardiopulmonary, liver, kidney and coagulation dysfunction
• Chemotherapy and radiotherapy were administered 1 month before surgery, and sedatives, antiemetic or antipruritic drugs were administered 24 hours before surgery
• History of drug abuse, chronic pain, mental illness, or allergy to the drugs used in this study
• Plan postoperative intubation or transfer to ICU;
• Participated in other clinical studies within the past 3 months.

Sponsors & Collaborators

• Yongtao Sun: lead

Related Publications (5)

• Helme RD, Meliala A, Gibson SJ. Methodologic factors which contribute to variations in experimental pain threshold reported for older people. Neurosci Lett. 2004 May 6;361(1-3):144-6. doi: 10.1016/j.neulet.2003.12.014.

  PMID: 15135914 BACKGROUND

• Schofield PA. The assessment and management of peri-operative pain in older adults. Anaesthesia. 2014 Jan;69 Suppl 1:54-60. doi: 10.1111/anae.12520.

  PMID: 24303861 BACKGROUND

• Joshi GP. Multimodal analgesia techniques and postoperative rehabilitation. Anesthesiol Clin North Am. 2005 Mar;23(1):185-202. doi: 10.1016/j.atc.2004.11.010.

  PMID: 15763418 BACKGROUND

• Yeh YC, Lin TF, Lin FS, Wang YP, Lin CJ, Sun WZ. Combination of opioid agonist and agonist-antagonist: patient-controlled analgesia requirement and adverse events among different-ratio morphine and nalbuphine admixtures for postoperative pain. Br J Anaesth. 2008 Oct;101(4):542-8. doi: 10.1093/bja/aen213. Epub 2008 Jul 17.

  PMID: 18640992 BACKGROUND

• Pasternak GW. Molecular biology of opioid analgesia. J Pain Symptom Manage. 2005 May;29(5 Suppl):S2-9. doi: 10.1016/j.jpainsymman.2005.01.011.

  PMID: 15907642 BACKGROUND

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Yongtao Sun, Ph.D.

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

  STUDY CHAIR

Central Study Contacts

Yongtao Sun, Ph.D.

CONTACT

18660795201; sunyongtao1979@163.com

weiwei wang, M.A.

CONTACT

18678653965; www18678653965@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 16, 2025
• First Posted: May 1, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 10, 2026
• Last Updated: May 1, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share