Pain
Conditions
Interventions
Morning group (Part I):NA
Afternoon group (Part I):NA
IoC2 group (Part II):IoC2 monitoring-guided opioid titration
Standard practice group (Part II): opioid titration based on hemodynamic parameters
Sponsors
China-Japan Friendship Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: Part I Prospective cohort study: 1. Age 18-64 years; 2. ASA I~II; 3. Elective laparoscopic cholecystectomy under general anesthesia; Part II Randomized controlled study: 1. Age 65 ~ 90 years; 2. ASA II~III; 3. Elective colorectal surgery under general anesthesia; 4. Agree to use patient-controlled intravenous analgesia (PCIA) after surgery; 5. Right dominant hand
Exclusion criteria
Exclusion criteria: 1: Part I Prospective cohort study: 1. Patients refused to participate in the study; 2. History of chronic pain, or use of opioid analgesics within 1 month before surgery; 3. Implantation of a pacemaker or taking beta-blockers, or arrhythmia; 4. Poor preoperative systemic disease control, including but not limited to poor hypertension control (SBP= 160 mmHg and/or DBP=100 mmHg after taking the drug), poor hyperglycemia control (cerebral infarction or cerebral hemorrhage within 3 months), etc.; 5. History of mental illness or cognitive dysfunction; 6. Underweight (BMI 30 kg /m2); 7. History of heavy smoking or alcohol abuse; 8. Pregnancy; 9. Conversion to laparotomy during difficult surgery, or bleeding volume exceeding 200ml or operation time exceeding 3h. 2: Part II Randomized controlled study: 1. Patients refused to participate in the study; 2. History of chronic pain, or use of opioid analgesics within 1 month before surgery; 3. Poor preoperative control of serious systemic diseases This includes, but is not limited to, severe heart disease (such as acute coronary syndrome, new atrial fibrillation, NYHA cardiac function =3, etc.), poor hypertension control (SBP=180 mm Hg and/or DBP=110 mm Hg after medication), and poor hyperglycemia control (fasting blood glucose =180mg/dL and/or HbA1c=10%), recent cerebrovascular events (cerebral infarction or cerebral hemorrhage within 3 months), severe pulmonary diseases such as acute exacerbation of COPD, hepatic and renal insufficiency, etc. 4. History of mental illness or cognitive dysfunction before surgery; 5. Underweight (BMI 30 kg /m2); 6. History of heavy smoking (=20 cigarettes/day) or alcohol abuse (=40g/ day) in the past 5 years; 7. Conversion to laparotomy during difficult surgery, or bleeding volume exceeding 1000ml or operation time exceeding 5h. 8.Tansfer to ICU after surgery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Intraoperative sufentanil comsuption; | — |
Secondary
| Measure | Time frame |
|---|---|
| Sufentanil consumption on postoperative day 2 and day 1;Postoperative NRS score;Mechanical pain threshold;Time of extubation;Aldrete score;Length of stay in PACU;Frequence of occurrences of PONV;Postoperative delirium;Level of IL-6;Peripheral blood sufentanil concentration;Remedial use of analgesics;Incidence of intraoperative hemodynamic events;Administration times and consumption of ephedrine;Pump rate and consumption of norepinephrine; | — |
Countries
China
Contacts
Public ContactXiaowen Liu
China-Japan Friendship Hospital
Outcome results
None listed