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

NCT06304181 — Not applicable, Unknown, 90 participants, The Fourth Affiliated Hospital of Zhejiang University School of Medicine

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Registry	NCT06304181
Status	Unknown
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: double, treatment
Enrollment	90 (Estimated)
Sponsor	The Fourth Affiliated Hospital of Zhejiang University School of Medicine (Other)
Conditions	Postoperative Analgesia
Interventions	Paracetamol and Mannitol Injection, Parecoxib (Drug)
Dates	start 2024-03-15 (estimated), primary completion 2024-08-01 (estimated), completion 2024-12-30 (estimated), first posted 2024-03-12, last updated 2024-03-12

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Paracetamol and Mannitol Injection group	Experimental	Drug: Paracetamol and Mannitol Injection	Paracetamol and Mannitol Injection 500mg was given intravenously 30 minutes before the end of the operation
Parecoxib group	Active comparator	Drug: Parecoxib	40mg of parecoxib was given intravenously 30min before the end of the operation

Paracetamol and Mannitol Injection (Drug), also known as Acetaminophen Mannitol Injection: Paracetamol and Mannitol Injection 500mg
Parecoxib (Drug): 40mg of parecoxib

+Outcome measures

Primary outcomes

NRS scores [after extubation 10 (±5) minutes, before leaving the resuscitation room, 6 hours, 12 hours, 24 hours after surgery]: NRS scores at rest and during movement (coughing) after extubation 10 (±5) minutes, before leaving the resuscitation room, 6 hours, 12 hours, 24 hours after surgery
RASS score [after extubation 10 (±5) minutes and 24 hours after surgery]: RASS score after extubation 10 (±5) minutes and 24 hours after surgery

Secondary outcomes

Time of first use of remedial analgesics or analgesic pump [From the end of surgery until the date of first use of remedial analgesics or analgesic pumps,assessed up to 3 days]: Time of first use of remedial analgesics or analgesic pump after surgery,assessed up to 3 days
Total analgesic pump drug use [From the end of surgery until removal of the analgesic pump,assessed up to 3 days]: The total drug use of analgesic pump was recorded during follow-up
Postoperative liver enzyme level [Time 1 (Within 5 minutes of the surgery), Time 2 (1 day post-surgery), Time 3 (2 days post-surgery)]: Measurement of level of liver enzymes in the blood in Time 1 (Within 5 minutes of the surgery), Time 2 (1 day post-surgery), Time 3 (2 days post-surgery)
Postoperative bilirubin level [Time 1 (Within 5 minutes of the surgery), Time 2 (1 day post-surgery), Time 3 (2 days post-surgery)]: Measurement of level of bilirubin in the blood in Time 1 (Within 5 minutes of the surgery), Time 2 (1 day post-surgery), Time 3 (2 days post-surgery)
Postoperative creatinine level [Time 1 (Within 5 minutes of the surgery), Time 2 (1 day post-surgery), Time 3 (2 days post-surgery)]: Measurement of level of creatinine in the blood in Time 1 (Within 5 minutes of the surgery), Time 2 (1 day post-surgery), Time 3 (2 days post-surgery)
Postoperative cortisol level [Time 1 (Within 5 minutes of the surgery), Time 2 (1 day post-surgery), Time 3 (2 days post-surgery)]: Measurement of level of ccortisol in the blood in Time 1 (Within 5 minutes of the surgery), Time 2 (1 day post-surgery), Time 3 (2 days post-surgery)
Postoperative IL-6 level [Time 1 (Within 5 minutes of the surgery), Time 2 (1 day post-surgery), Time 3 (2 days post-surgery)]: Measurement of level of IL-6 in the blood in Time 1 (Within 5 minutes of the surgery), Time 2 (1 day post-surgery), Time 3 (2 days post-surgery)
Postoperative IL-8 level [Time 1 (Within 5 minutes of the surgery), Time 2 (1 day post-surgery), Time 3 (2 days post-surgery)]: Measurement of level of IL-8 in the blood in Time 1 (Within 5 minutes of the surgery), Time 2 (1 day post-surgery), Time 3 (2 days post-surgery)

+Eligibility

Sex: All, ages: 18 Years to 60 Years, 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