Impact of Frailty on the Median Effective Dose of Nalbuphine in Patient-Controlled Intravenous Analgesia for Postoperative Pain in Elderly Patients Undergoing Laparoscopic Gastrointestinal Surgery: A Prospective, Double-Blind, Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 主要终点
- Median Effective Dose (ED50) of Nalbuphine Based on Visual Analogue Scale (VAS) for Resting Pain at 24 Hours After Surgery
研究概览
简要总结
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.
详细描述
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:
- Enhanced pain perception.
- Decreased pain tolerance.
- Changes in pharmacokinetics and pharmacodynamics.
- 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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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);
- •18.5 kg/m²≤BMI<30 kg/m²;
- •Sign the informed consent form.
排除标准
- •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.
结局指标
主要结局
Median Effective Dose (ED50) of Nalbuphine Based on Visual Analogue Scale (VAS) for Resting Pain at 24 Hours After Surgery
时间窗: Within 24 hours after the end of 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.
次要结局
- Rescue Analgesic Requirements Within 48 Hours After Surgery(At 6, 12, 18, 24, 36, and 48 hours after the end of surgery)
- Systolic Blood Pressure (SBP) Within 48 Hours After Surgery(At PACU discharge, and at 6, 12, 18, 24, 36, and 48 hours after surgery)
- 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)
- the effective pressing number of PCIA(At PACU discharge (immediately after anesthesia recovery), and at 6, 12, 18, 24, 36, and 48 hours after the end of surgery)
- the cumulative pressing number of PCIA(At PACU discharge (immediately after anesthesia recovery), and at 6, 12, 18, 24, 36, and 48 hours after the end of surgery)
- sufentanil dose(Exiting PACU immediately)
- Time to recovery(Exiting PACU immediately)
- Postoperative Functional Recovery Milestones at Hospital Discharge(At hospital discharge, typically within 3 to 7 days after surgery)
- Number of Participants Experiencing Respiratory Depression (RR <8/min or SpO₂ ≤90%) After Surgery(At PACU discharge (immediately after anesthesia recovery), and at 6, 12, 18, 24, 36, and 48 hours after the end of surgery)
- Number of Participants Requiring Antipruritic Medication for Persistent Itching After Surgery(At PACU discharge (immediately after anesthesia recovery), and at 6, 12, 18, 24, 36, and 48 hours after the end of surgery)
- Diastolic Blood Pressure (DBP) Within 48 Hours After Surgery(At PACU discharge, and at 6, 12, 18, 24, 36, and 48 hours after surgery)
- Mean Arterial Pressure (MAP) Within 48 Hours After Surgery(At PACU discharge, and at 6, 12, 18, 24, 36, and 48 hours after surgery)
- Heart Rate (HR) Within 48 Hours After Surgery(At PACU discharge, and at 6, 12, 18, 24, 36, and 48 hours after surgery)
- Peripheral Oxygen Saturation (SpO₂) Within 48 Hours After Surgery(At PACU discharge, and at 6, 12, 18, 24, 36, and 48 hours after surgery)
研究者
Yongtao Sun
Professor
Qianfoshan Hospital