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

NCT ID: NCT06304181

Last Updated: 2024-03-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-15

Study Completion Date

2024-12-30

Brief Summary

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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

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Conditions

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Postoperative Analgesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Paracetamol and Mannitol Injection group

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

Group Type EXPERIMENTAL

Paracetamol and Mannitol Injection

Intervention Type DRUG

Paracetamol and Mannitol Injection 500mg

Parecoxib group

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

Group Type ACTIVE_COMPARATOR

Parecoxib

Intervention Type DRUG

40mg of parecoxib

Interventions

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Paracetamol and Mannitol Injection

Paracetamol and Mannitol Injection 500mg

Intervention Type DRUG

Parecoxib

40mg of parecoxib

Intervention Type DRUG

Other Intervention Names

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Acetaminophen Mannitol Injection

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The Fourth Affiliated Hospital of Zhejiang University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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JianHong Xu

Role: CONTACT

86-18867961109

Other Identifiers

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KY-2023-195

Identifier Type: -

Identifier Source: org_study_id

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