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

NCT06304181 | Not Yet Recruiting

• 1 other identifier: KY-2023-195
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Postoperative Analgesia

Keywords

Paracetamol and Mannitol Injection; postoperative analgesia; thoracic surgery

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (8)

• 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

• Total analgesic pump drug use

  From the end of surgery until removal of the analgesic pump,assessed up to 3 days

• Postoperative liver enzyme level

  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)

• Postoperative creatinine level

  Time 1 (Within 5 minutes of the surgery), Time 2 (1 day post-surgery), Time 3 (2 days post-surgery)

Study Arms (2)

Paracetamol and Mannitol Injection group

EXPERIMENTAL

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

Drug: Paracetamol and Mannitol Injection

Parecoxib group

ACTIVE COMPARATOR

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

Drug: Parecoxib

Interventions

Paracetamol and Mannitol Injection DRUG

Paracetamol and Mannitol Injection 500mg

Also known as: Acetaminophen Mannitol Injection

Paracetamol and Mannitol Injection group

Parecoxib DRUG

40mg of parecoxib

Parecoxib group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Obtain informed consent；
• Patients scheduled for partial lobectomy under thoracoscopy with general anesthesia；
• Classified as American Society of Anesthesiologists (ASA) physical status I\~II；
• Age over 18 years；
• Patients voluntarily participate and sign the informed consent form

You may not qualify if:

• Systolic blood pressure ≥180 mm Hg or \<90 mm Hg, diastolic blood pressure ≥110 mm Hg or \<60 mmHg
• heart rate \<50 beats/min；
• 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
• severe kidney dysfunction: creatinine clearance \<60 ml/min)；
• Patients with diabetes and complications (diabetic ketoacidosis, hyperosmolar coma, various infections, major vascular changes, diabetic nephropathy, retinopathy, diabetic cardiomyopathy, diabetic neuropathy, diabetic foot, etc.)；
• Patients with severe pulmonary impairment, such as asthma or chronic obstructive pulmonary disease；
• History of psychiatric illness or long-term use of psychiatric drugs, chronic pain medication, or history of alcohol abuse；
• Neuromuscular diseases；
• Tendency towards malignant hyperthermia；
• Allergy to the study drug or other contraindications；
• Participation in another drug clinical trial within the past 30 days；
• Any cerebrovascular accidents such as stroke, transient ischemic attack (TIA) in the last 3 months；
• Unstable angina, myocardial infarction in the last 3 months；
• Undergone another surgery within the last 3 months；
• Coagulopathy

Sponsors & Collaborators

• The Fourth Affiliated Hospital of Zhejiang University School of Medicine: lead

MeSH Terms

Interventions

Acetaminophen; Mannitol; parecoxib

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Sugar Alcohols; Alcohols; Carbohydrates

Central Study Contacts

JianHong Xu

CONTACT

86-18867961109; xujh1969@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2024
• First Posted: March 12, 2024
• Study Start: March 15, 2024
• Primary Completion: August 1, 2024
• Study Completion: December 30, 2024
• Last Updated: March 12, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share