Clinical trial NCT06304181: Effect of Paracetamol and Mannitol Injection on Postoperative Analgesia in Patients With Thoracoscopic Lobectomy
Official title: Effect of Paracetamol and Mannitol Injection on Postoperative Analgesia in Patients With Thoracoscopic Lobectomy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Postoperative Analgesia
Keywords: Paracetamol and Mannitol Injection
postoperative analgesia
thoracic surgery
Lead sponsor: The Fourth Affiliated Hospital of Zhejiang University School of Medicine
Sponsor class: OTHER
First posted: 2024-03-12
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study thoroughly evaluates the efficacy of acetaminophen mannitol injection for postoperative analgesia in patients undergoing thoracoscopic lobectomy, by comparing it with a control group.


Eligibility criteria: Inclusion Criteria:

1. Obtain informed consent；
2. Patients scheduled for partial lobectomy under thoracoscopy with general anesthesia；
3. Classified as American Society of Anesthesiologists (ASA) physical status I\~II；
4. Age over 18 years；
5. Patients voluntarily participate and sign the informed consent form

Exclusion Criteria:

1. Systolic blood pressure ≥180 mm Hg or \<90 mm Hg, diastolic blood pressure ≥110 mm Hg or \<60 mmHg
2. heart rate \<50 beats/min；
3. Patients with severe liver or kidney dysfunction (severe liver dysfunction: ALT, conjugated bilirubin, AST, ALP, total bilirubin any one \>2 times the upper limit of normal
4. severe kidney dysfunction: creatinine clearance \<60 ml/min)；
5. Patients with diabetes and complications (diabetic ketoacidosis, hyperosmolar coma, various infections, major vascular changes, diabetic nephropathy, retinopathy, diabetic cardiomyopathy, diabetic neuropathy, diabetic foot, etc.)；
6. Patients with severe pulmonary impairment, such as asthma or chronic obstructive pulmonary disease；
7. History of psychiatric illness or long-term use of psychiatric drugs, chronic pain medication, or history of alcohol abuse；
8. Neuromuscular diseases；
9. Tendency towards malignant hyperthermia；
10. Allergy to the study drug or other contraindications；
11. Participation in another drug clinical trial within the past 30 days；
12. Any cerebrovascular accidents such as stroke, transient ischemic attack (TIA) in the last 3 months；
13. Unstable angina, myocardial infarction in the last 3 months；
14. Undergone another surgery within the last 3 months；
15. Coagulopathy

Primary outcomes:
measure: NRS scores
timeFrame: after extubation 10 (±5) minutes, before leaving the resuscitation room, 6 hours, 12 hours, 24 hours after surgery
measure: RASS score
timeFrame: after extubation 10 (±5) minutes and 24 hours after surgery
Secondary outcomes:
measure: Time of first use of remedial analgesics or analgesic pump
timeFrame: From the end of surgery until the date of first use of remedial analgesics or analgesic pumps,assessed up to 3 days
measure: Total analgesic pump drug use
timeFrame: From the end of surgery until removal of the analgesic pump,assessed up to 3 days
measure: Postoperative liver enzyme level
timeFrame: Time 1 (Within 5 minutes of the surgery), Time 2 (1 day post-surgery), Time 3 (2 days post-surgery)
measure: Postoperative bilirubin level
timeFrame: Time 1 (Within 5 minutes of the surgery), Time 2 (1 day post-surgery), Time 3 (2 days post-surgery)
measure: Postoperative creatinine level
timeFrame: Time 1 (Within 5 minutes of the surgery), Time 2 (1 day post-surgery), Time 3 (2 days post-surgery)
measure: Postoperative cortisol level
timeFrame: Time 1 (Within 5 minutes of the surgery), Time 2 (1 day post-surgery), Time 3 (2 days post-surgery)
measure: Postoperative IL-6 level
timeFrame: Time 1 (Within 5 minutes of the surgery), Time 2 (1 day post-surgery), Time 3 (2 days post-surgery)
measure: Postoperative IL-8 level
timeFrame: Time 1 (Within 5 minutes of the surgery), Time 2 (1 day post-surgery), Time 3 (2 days post-surgery)
Other outcomes:
Locations:
Study officials:
References: