Impact of Frailty on Nalbuphine Dose for Postoperative Analgesia in Elderly Patients Undergoing Laparoscopic GI Surgery
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age65+
SponsorYongtao Sun
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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;
Trial population
Elderly patients undergoing laparoscopic gastrointestinal surgery
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
120 Participants
are grouped into 3 trial groupsGroup A: frailty group（F）（mFI≧0.27）
Group B: pre-frailty group (P)(0<mFI<0.27)
Group C: non-frailty group (N)（mFI=0）
Trial outcomes
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.
Time frame
Within 24 hours after the end of surgerySecondary outcomes
1
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
Time frame
Within 24 hours after the end of surgery2
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.
Time frame
At PACU discharge (immediately after anesthesia recovery), and at 6, 12, 18, 24, 36, and 48 hours after the end of surgery3
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.
Time frame
At PACU discharge (immediately after anesthesia recovery), and at 6, 12, 18, 24, 36, and 48 hours after the end of surgery4
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.
Time frame
At PACU discharge (immediately after anesthesia recovery), and at 6, 12, 18, 24, 36, and 48 hours after the end of surgeryLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Yongtao Sun
Lead sponsor
Qianfoshan Hospital
Sponsor institution
Source ClinicalTrials.gov
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