The elderly patients with moderate to severe pain after intestinal surgery
Conditions
Interventions
control group:sufentanil
Sponsors
The Third Xiangya Hospital of Central South University
Eligibility
Sex/Gender
All
Age
65 Years to 80 Years
Inclusion criteria
Inclusion criteria: (1) Aged 65-80 years, male and female; (2) Patients underwent elective bowel surgery under general anesthesia (such as colorectal cancer radical surgery, etc.), with a single incision greater than 5 cm, and expected to require Patient-Controlled Intravenous Analgesia treatment (moderate to severe pain) for more than 24 hours after surgery; (3) ASA I-III; (4) BMI (Body Mass Index) 18 to 30 kg/m2; (5) Patients who can understand the research process and use the pain scale, can operate PCIA (patient-controlled analgesia equipment), and can effectively communicate with researchers; (6) Patients agree to be enrolled voluntarily in this study,and ICF was signed.
Exclusion criteria
Exclusion criteria: (1) Patients who have participated in clinical trials of other drugs in the last 3 months; (2) Acute (slow) alcoholism, history of neurological diseases; history of chronic pain; drug addiction and alcoholism; long-term history of opioid use; (3) Patients who have taken monoamine oxidase inhibitors or antidepressants within 15 days; (4) Patients who are allergic to or have contraindications to any component of opioids, propofol, cis-atracurium, atropine, neostigmine, and excipients; (5) Have a history of serious cardiovascular system (eg: Hypertensive patients whose blood pressure is still above the third level with antihypertensive drugs (ie, resting SBP >= 180 mmHg and/or DBP >= 110 mmHg), heart failure, severe arrhythmia, etc.); patients with unstable angina or myocardial infarction within the past 6 months; resting ECG heart rate < 50 beats per minute, or third-degree AV block; (6) Preoperative liver and kidney function: abnormality of alanine aminotransferase (ALT), aspartate aminotransferase (AST), urea nitrogen (BUN), creatinine (Cr) (ALT and AST are greater than two times the upper limit of normal, BUN and Cr are 1.5 times higher than the upper limit of normal value); (7) Patients with complete intestinal obstruction after medical treatment; (8) Craniocerebral injury, possible presence of intracranial hypertension, cerebral aneurysm, cerebrovascular accident, and patients with central nervous system, respiratory system (respiratory failure, etc.) diseases; mental system diseases (schizophrenia, mania, bipolar abnormalities) , Insanity, etc.) and long-term use of psychotropic drugs and cognitive impairment; (9) Patients who cannot express their wishes correctly; those with poor compliance and unable to complete the trial according to the study protocol ; (10) The patients whom investigators did not consider appropriate to participate the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effective compression times of PCA pump within 24 hours; | — |
Secondary
| Measure | Time frame |
|---|---|
| The area under the pain-time curve (AUC) at rest (1-24h, 6-24h, 12-24h);The area under the pain-time curve (AUC) in motion (1-24h,6-24h,12-24h);Incidence and grade of PONV at 1h, 3h, 6h, 12h, 24h (common adverse reactions);Incidence of other opioid-related adverse events;Patient anesthesia satisfaction score;Investigator anesthesia satisfaction score;Intestinal function recovery time; | — |
Countries
China
Contacts
Public ContactWen Ouyang
The Third Xiangya Hospital of Central South University
Outcome results
None listed