Effect of Paracetamol and Mannitol Injection on Postoperative Analgesia in Patients With Thoracoscopic Lobectomy

The Fourth Affiliated Hospital of Zhejiang University School of Medicine

Status: Not yet enrolling

Conditions: Postoperative Analgesia

Treatments: Drug: Paracetamol and Mannitol Injection; Drug: Parecoxib

Study type: Interventional

Funder types: Other

Identifiers

NCT06304181

KY-2023-195

Details and patient eligibility

About

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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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90 participants in 2 patient groups

Paracetamol and Mannitol Injection group

Experimental group

Description:

Paracetamol and Mannitol Injection 500mg was given intravenously 30 minutes before the end of the operation

Treatment:

Drug: Paracetamol and Mannitol Injection

Parecoxib group

Active Comparator group

Description:

40mg of parecoxib was given intravenously 30min before the end of the operation

Treatment:

Drug: Parecoxib