Effect of Acetaminophen Preemptive Analgesia on Postoperative Cognitive Function

Phase 1

Recruiting

• Conditions: Cognitive Function
• Interventions: Drug: acetaminophen mannitol; Drug: Normal saline

• Registration Number: NCT06004687
• Lead Sponsor: Affiliated Hospital of Nantong University

Brief Summary

Patients undergoing gastrointestinal tumor surgery are prone to delayed recovery and postoperative cognitive dysfunction due to greater trauma and longer operation time. Pre-analgesia can reverse the effects of nociceptive stimulation on recovery from general anesthesia and postoperative cognitive function. Intravenous injection of non-steroidal drugs can effectively reduce postoperative pain and the use of opioids. Therefore, This study selected acetaminophen mannitol injection for preemptive analgesia to observe the effects on anesthesia recovery time and postoperative cognitive function of patients undergoing gastrointestinal tumor surgery, providing new ideas for reducing cognitive dysfunction in patients undergoing gastrointestinal tumor surgery

Detailed Description

By administering acetaminophen to patients with gastrointestinal tumors before surgery, recording the time to recovery from anesthesia, and assessing cognitive function status by CAM on the first, third, and seventh day after surgery

Study Timeline

• Status Verified: 2023-07
• Study Start: 2023-07-26
• Study First Submitted: 2023-08-09
• Study First Submitted QC: 2023-08-20
• Last Update Submitted: 2023-08-20
• Study First Posted: 2023-08-22
• Last Update Posted: 2023-08-22
• Primary Completion: 2024-05-30
• Study Completion: 2024-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Patients undergoing gastrointestinal tumor surgery
• American Society of Anesthesiologists（ASA）≤Ⅲ

Exclusion Criteria

• History of severe adverse reactions to oral acetaminophen
• Dysfunction of heart, liver, kidney and other important organs
• History of chronic pain
• Oral non-steroidal or opioid drugs
• Patients who do not accept clinical trials

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
By applying acetaminophen mannitol to patients with gastrointestinal tumors before surgery	acetaminophen mannitol	Acetaminophen mannitol injection 50ml(500mg) intravenously pumped 30 minutes before surgery
By applying normal saline to patients with gastrointestinal tumors before surgery	Normal saline	Normal saline injection 50ml intravenously pumped 30 minutes before surgery

Primary Outcome Measures

Name	Time	Method
Postoperative delirium	1/3/7 days after the surgery	The confusion assessment method (CAM) was used to assess postoperative cognitive dysfunction

Secondary Outcome Measures

Name	Time	Method
Recovery time	immediately after the surgery	The postoperative recovery time was recorded

Trial Locations

Locations (1)

Affiliated Hospital of nantong University; 🇨🇳 Nantong, Jiangsu, China