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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-10-01

Study Completion Date

2026-10-10

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effects of Comprehensive Intestinal Protection Strategy on Postoperative Intestinal Complications

NCT03216759

Intestinal Complications Laparotomy

UNKNOWN NA

Comparison of the Effects of Fentanyl, Oxycodone, Butorphanol on Gastrointestinal Function

NCT04295109

Cervix Neoplasms Endometrial Cancer Adenomyosis +1 more

UNKNOWN NA

The Impact of Low-Dose Esketamine Combined With Ciprofol on the Quality of Early Postoperative Recovery Among Elderly Patients Undergoing Painless Gastroscopy

NCT06617039

Quality of Postoperative Recovery

ACTIVE_NOT_RECRUITING NA

Comparison of the Effects of Continuous Epidural Analgesia and Continuous Intravenous Analgesia on Postoperative Bowel Movement in Patients Undergoing Laparoscopic Gastrectomy

NCT02458573

Gastric Cancer

COMPLETED PHASE4

Effect of IV Nalbuphine on Nausea and Vomiting Following Intrathecal Morphine

NCT05704673

Inguinal Hernia

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

With the increasing aging of the population in China, the proportion of elderly patients in the surgical population is continuously rising, with elderly frail patients accounting for as high as 25-50%. Previous studies have shown that postoperative pain management in elderly frail patients is associated with four major issues:

1. Enhanced pain perception.
2. Decreased pain tolerance.
3. Changes in pharmacokinetics and pharmacodynamics.
4. Iatrogenic titration patterns.

Patient-controlled intravenous analgesia (PCIA) is one of the most commonly used analgesic methods, which can shorten hospital stays, reduce the incidence of perioperative complications, and improve quality of life. However, elderly patients are more prone to hypotension, nausea, and vomiting, necessitating additional antiemetics and rescue analgesics. Nalbuphine, a dual-acting drug as a κ-receptor agonist and μ-receptor antagonist, has analgesic potency comparable to morphine and a longer duration of action (3-6 hours). However, studies have shown that due to reduced liver and kidney function, the metabolism of Nalbuphine is prolonged in elderly frail patients. Dexmedetomidine, a highly selective α2-receptor agonist with sedative, analgesic, anxiolytic, and sympatholytic properties, can reduce postoperative cardiovascular complications, enhance opioid analgesia, and lower the incidence of postoperative delirium, making it an ideal choice for multimodal analgesia. However, no studies have yet explored the dose-response relationship of dexmedetomidine combined with Nalbuphine in elderly frail patients, especially the impact of different degrees of frailty (such as mFI classification) on the median effective dose (ED50) of Nalbuphine.

This study, for the first time, employs the modified Dixon up-and-down sequential method to systematically evaluate the influence of different degrees of frailty on the ED50 of Nalbuphine-dexmedetomidine combination analgesia in elderly patients undergoing laparoscopic gastrointestinal surgery, and to analyze its analgesic effects and complication risks. The results of this study will provide evidence-based guidance for precise pain management in frail patients and promote the application of Enhanced Recovery After Surgery (ERAS) principles in the elderly frail population.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

PCIA Frailty Laparoscopic Gastrointestinal Surgery

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

No interventions assigned to this group

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No