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

Not Applicable

Not yet recruiting

• Conditions: Postoperative Analgesia
• Interventions: Drug: Paracetamol and Mannitol Injection; Drug: Parecoxib

• Registration Number: NCT06304181
• Lead Sponsor: The Fourth Affiliated Hospital of Zhejiang University School of Medicine

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-02-19
• Status Verified: 2024-03
• Study First Submitted QC: 2024-03-04
• Last Update Submitted: 2024-03-04
• Study First Posted: 2024-03-12
• Last Update Posted: 2024-03-12
• Study Start: 2024-03-15
• Primary Completion: 2024-08-01
• Study Completion: 2024-12-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Paracetamol and Mannitol Injection group	Paracetamol and Mannitol Injection	Paracetamol and Mannitol Injection 500mg was given intravenously 30 minutes before the end of the operation
Parecoxib group	Parecoxib	40mg of parecoxib was given intravenously 30min before the end of the operation

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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
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 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 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)