Impact of Frailty on Nalbuphine Dose for Postoperative Analgesia in Elderly Patients Undergoing Laparoscopic GI Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: PCIA, Frailty, Laparoscopic Gastrointestinal Surgery. Basic parameters: from 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.
Detailed description
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.
Primary outcome measures
- 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]
Secondary outcome measures (12)
- Dose of Nalbuphine Required to Achieve Resting VAS ≤3 in 95% of Patients Within 24 Hours After Surgery (ED95) [Time frame: Within 24 hours after the end of surgery]
- Resting/Moving VAS (VASR/ VASM) [Time frame: 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) [Time frame: 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) [Time frame: 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) [Time frame: 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 [Time frame: 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 [Time frame: At PACU discharge (immediately after anesthesia recovery), and at 6, 12, 18, 24, 36, and 48 hours after the end of surgery]
- sufentanil dose [Time frame: Exiting PACU immediately]
- Time to recovery [Time frame: Exiting PACU immediately]
- Postoperative Functional Recovery Milestones at Hospital Discharge [Time frame: At hospital discharge, typically within 3 to 7 days after surgery]
- Rescue Analgesic Requirements Within 48 Hours After Surgery [Time frame: At 6, 12, 18, 24, 36, and 48 hours after the end of surgery]
- Systolic Blood Pressure (SBP) Within 48 Hours After Surgery [Time frame: At PACU discharge, and at 6, 12, 18, 24, 36, and 48 hours after surgery]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Publications
- 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
- 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
- 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
- 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
- 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
- Wang W, Wei C, Chen S, Wu G, Xu L, Gao X, Du Y, Liu M, Zhang M, Sun Y. Frailty-stratified effective dose of nalbuphine for postoperative analgesia in elderly patients undergoing laparoscopic gastrointestinal surgery: a modified Dixon-based dose-finding protocol. BMC Geriatr. 2026 Mar 9;26(1):531. doi: 10.1186/s12877-026-07308-x. PMID 41803697
Identifiers
NCT: NCT06953570 · Nalbuphine