PCIANCT06953570
Impact of Frailty on Nalbuphine Dose for Postoperative Analgesia in Elderly Patients Undergoing Laparoscopic GI Surgery
An observational study of PCIA and Frailty, run by Yongtao Sun.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- PCIA, Frailty, Laparoscopic Gastrointestinal Surgery
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2025to 10 Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Elderly patients undergoing laparoscopic gastrointestinal surgery
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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.
Read the 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:
- 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.
- Conditions
- PCIA, Frailty, Laparoscopic Gastrointestinal Surgery
- Keywords
- nalbuphine, ED50, PCIA, laparoscopic gastrointestinal surgery, frailty
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
The 95% effective dose (ED95) of nalbuphine is defined as the dose at which 95% of patients report a resting pain score of ≤3 on the Visual Analogue Scale (VAS) within 24 hours after laparoscopic gastrointestinal surgery. The VAS is a 10-cm horizontal line scale from 0 (no pain) to 10 (worst pain imaginable), evaluated in a supine resting state
Measured: Within 24 hours after the end of surgery
Resting/Moving VAS (VASR/ VASM)
The VAS is assessed at rest and during moving (coughing or changing position from back to side in bed). The pain degree was assessed with a 10cm scale (0-10 points) : 0 was no pain; A score below 3 indicates mild pain, which the patient can tolerate; 4-6 patients pain and affect sleep, can still tolerate; 7-10 points patients have gradually intense pain, the pain is unbearable.
Measured: 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)
1 awake, patient anxious, restless or irritable; 2 points awake, patient cooperation, good orientation or quiet; At 3 points of wakefulness, the patient only responds to commands; 4 minutes sleep, patients respond quickly to tapping eyebrow or Johnson stimulation; 5 minutes sleep, the patient is slow to tap eyebrow or Johnson stimulation; 6 minutes of sleep, the person did not respond to tapping the eyebrow or Johnson stimulation.
Measured: 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)
0 is persistent pain; 1 is painless at rest, severe pain when breathing deeply or coughing; 2 are painless at rest, mild pain when breathing deeply or coughing; There was no pain during 3 minutes of quiet and deep breathing. 4 points: No pain when coughing.
Measured: 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)
Nausea is an uncomfortable feeling of wanting to vomit, but there is no contractive movement of the abdominal muscles, diaphragm muscles, etc. Vomiting refers to the contraction of the diaphragm, chest muscles and abdominal wall muscles, which may be accompanied by vomiting of stomach contents, including dry heaving. If the vomiting events are more than 1 minute apart, they are considered separate episodes. 0 degree indicates no nausea or vomiting. Grade I is nausea and no vomiting; Grade Ⅱ was nausea with mild vomiting; Degree III is severe vomiting requiring further treatment; Grade IV is vomiting that is difficult to control.
Measured: 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
The effective number of PCIA compressions performed by the patient after surgery
Measured: 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
The total number of postoperatively applied PCIA
Measured: At PACU discharge (immediately after anesthesia recovery), and at 6, 12, 18, 24, 36, and 48 hours after the end of surgery
sufentanil dose
rescue sufentanil doses in PACU
Measured: Exiting PACU immediately
Time to recovery
length of stay in PACU
Measured: Exiting PACU immediately
Postoperative Functional Recovery Milestones at Hospital Discharge
Functional recovery is defined as the ability of the patient to (1) independently get out of bed, (2) walk at least 10 meters with or without assistance, (3) tolerate oral intake (clear fluids or diet), and (4) urinate spontaneously. Recovery is assessed using a standardized checklist by the attending physician or nurse prior to discharge.
Measured: At hospital discharge, typically within 3 to 7 days after surgery
Rescue Analgesic Requirements Within 48 Hours After Surgery
Number of additional doses of rescue analgesics administered to the patient within the first 48 hours postoperatively, recorded by nursing staff
Measured: At 6, 12, 18, 24, 36, and 48 hours after the end of surgery
Systolic Blood Pressure (SBP) Within 48 Hours After Surgery
SBP will be measured using automated patient monitors at predefined time points. The values will be recorded and analyzed as a continuous variable.
Measured: At PACU discharge, and at 6, 12, 18, 24, 36, and 48 hours after surgery
Number of Participants Experiencing Respiratory Depression (RR <8/min or SpO₂ ≤90%) After Surgery
Respiratory depression is defined as a respiratory rate <8 breaths per minute or an oxygen saturation (SpO₂) ≤90% on room air. The incidence will be recorded at each predefined time point by nursing staff using bedside monitors
Measured: 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
Pruritus is defined as persistent itching that leads to administration of antipruritic medication (e.g., antihistamines or corticosteroids). The number of participants requiring such medications at each time point will be recorded by medical staff.
Measured: 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
DBP will be measured using automated patient monitors at predefined time points. The values will be recorded and analyzed as a continuous variable.
Measured: At PACU discharge, and at 6, 12, 18, 24, 36, and 48 hours after surgery
Mean Arterial Pressure (MAP) Within 48 Hours After Surgery
MAP will be measured using automated patient monitors at each specified time point. MAP is calculated using the formula: (SBP + 2 × DBP) / 3.
Measured: At PACU discharge, and at 6, 12, 18, 24, 36, and 48 hours after surgery
Heart Rate (HR) Within 48 Hours After Surgery
Heart rate will be measured using automated patient monitors. The values will be recorded in beats per minute (bpm) and analyzed continuously over time.
Measured: At PACU discharge, and at 6, 12, 18, 24, 36, and 48 hours after surgery
Peripheral Oxygen Saturation (SpO₂) Within 48 Hours After Surgery
SpO₂ will be recorded using pulse oximetry. Oxygen saturation (%) will be continuously monitored and recorded at predefined intervals.
Measured: At PACU discharge, and at 6, 12, 18, 24, 36, and 48 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2025
- Study start1 Oct 2025 (estimated)
- Primary completion1 Oct 2026 (estimated)
- Study completion10 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for PCIAStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yongtao Sun
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yongtao Sun, Qianfoshan Hospital
- Investigators
- Yongtao Sun, Ph.D., Study chair, Qianfoshan Hospital, The First Hospital affiliated of Shandong First Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06953570
- Sponsor's protocol ID
- Nalbuphine
- Status last verified
- Apr 2025
- First submitted
- 16 Apr 2025
- Last updated
- 1 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 15135914Schofield 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.
PubMed 24303861Joshi 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.
PubMed 15763418Yeh 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.
PubMed 18640992Pasternak 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.
PubMed 15907642Wang 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.
PubMed 41803697
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06953570
- Acronym / sponsor ID
- Nalbuphine
- Conditions
- PCIA, Frailty, Laparoscopic Gastrointestinal Surgery
- Keywords
- nalbuphine, ED50, PCIA, laparoscopic gastrointestinal surgery, frailty
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Yongtao SunUniversity, hospital or other
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 10 Oct 2026 (estimated)
- First posted
- 1 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Elderly patients undergoing laparoscopic gastrointestinal surgery
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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.
18 secondary outcomes
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
Number of Participants Experiencing Respiratory Depression (RR <8/min or SpO₂ ≤90%) After Surgery
Time frame: 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
Time frame: 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
Time frame: At PACU discharge, and at 6, 12, 18, 24, 36, and 48 hours after surgery
Mean Arterial Pressure (MAP) Within 48 Hours After Surgery
Time frame: At PACU discharge, and at 6, 12, 18, 24, 36, and 48 hours after surgery
Heart Rate (HR) Within 48 Hours After Surgery
Time frame: At PACU discharge, and at 6, 12, 18, 24, 36, and 48 hours after surgery
Peripheral Oxygen Saturation (SpO₂) Within 48 Hours After Surgery
Time frame: At PACU discharge, and at 6, 12, 18, 24, 36, and 48 hours after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2025.
- Results publication: PubMed 15135914Helme 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.
- Results publication: PubMed 24303861Schofield 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.
- Results publication: PubMed 15763418Joshi 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.
- Results publication: PubMed 18640992Yeh 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.
- Results publication: PubMed 15907642Pasternak 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.
- Derived from this study: PubMed 41803697Wang 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.
- Individual participant dataSharing planned: No
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Postoperative Pain, Postoperative Ileus
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yongtao Sun, Ph.D. study chair
Qianfoshan Hospital, The First Hospital affiliated of Shandong First Medical University
Questions about this trial
What is this clinical trial studying?
An observational study of PCIA and Frailty, run by Yongtao Sun.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 May 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yongtao Sun, Ph.D. (18660795201, sunyongtao1979@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06953570, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2025.