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

Postoperative Analgesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06304181
• Other study ID #: KY-2023-195
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 15, 2024
• Est. completion date: December 30, 2024

Study information

• Verified date: March 2024
• Source: The Fourth Affiliated Hospital of Zhejiang University School of Medicine
• Contact: JianHong Xu
• Phone: 86-18867961109
• Email: xujh1969[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: December 30, 2024
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Postoperative Analgesia

Intervention

Drug:
• Paracetamol and Mannitol Injection
Paracetamol and Mannitol Injection 500mg
• Parecoxib
40mg of parecoxib

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The Fourth Affiliated Hospital of Zhejiang University School of Medicine

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	NRS scores	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	after extubation 10 (±5) minutes, before leaving the resuscitation room, 6 hours, 12 hours, 24 hours after surgery
Primary	RASS score	RASS score after extubation 10 (±5) minutes and 24 hours after surgery	after extubation 10 (±5) minutes and 24 hours after surgery
Secondary	Time of first use of remedial analgesics or analgesic pump	Time of first use of remedial analgesics or analgesic pump after surgery,assessed up to 3 days	From the end of surgery until the date of first use of remedial analgesics or analgesic pumps,assessed up to 3 days
Secondary	Total analgesic pump drug use	The total drug use of analgesic pump was recorded during follow-up	From the end of surgery until removal of the analgesic pump,assessed up to 3 days
Secondary	Postoperative liver enzyme level	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)	Time 1 (Within 5 minutes of the surgery), Time 2 (1 day post-surgery), Time 3 (2 days post-surgery)
Secondary	Postoperative bilirubin level	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)	Time 1 (Within 5 minutes of the surgery), Time 2 (1 day post-surgery), Time 3 (2 days post-surgery)
Secondary	Postoperative creatinine level	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)	Time 1 (Within 5 minutes of the surgery), Time 2 (1 day post-surgery), Time 3 (2 days post-surgery)
Secondary	Postoperative cortisol level	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)	Time 1 (Within 5 minutes of the surgery), Time 2 (1 day post-surgery), Time 3 (2 days post-surgery)
Secondary	Postoperative IL-6 level	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)	Time 1 (Within 5 minutes of the surgery), Time 2 (1 day post-surgery), Time 3 (2 days post-surgery)
Secondary	Postoperative IL-8 level	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)	Time 1 (Within 5 minutes of the surgery), Time 2 (1 day post-surgery), Time 3 (2 days post-surgery)