Effect of Acetaminophen Preemptive Analgesia on Postoperative Cognitive Function

Effects of Acetaminophen Preemptive Analgesia on Anesthesia Recovery Time and Postoperative Cognitive Function in Patients Undergoing Gastrointestinal Tumor Surgery

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

Study Overview

• Status: Recruiting
• Conditions: Cognitive Function
• Intervention / Treatment: Drug: acetaminophen mannitol; Drug: Normal saline

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 Type: Interventional
• Enrollment (Estimated): 100
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Hongsheng Chen; Phone Number: +86 513 81160313; Email: chenhongsheng8@163.com
• Study Contact Backup: Name: Chaochao Zhong; Phone Number: +86 513 81160313

Study Locations

• China
  • Jiangsu
    • Nantong, Jiangsu, China, 226001
      • Recruiting
      • Affiliated Hospital of Nantong University
      • Contact: Hongsheng Chen; Phone Number: +86 513 8116 0313

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: By applying acetaminophen mannitol to patients with gastrointestinal tumors before surgery; Acetaminophen mannitol injection 50ml(500mg) intravenously pumped 30 minutes before surgery	Drug: acetaminophen mannitol; Intravenous acetaminophen was administered 30 minutes before anesthesia
Placebo Comparator: By applying normal saline to patients with gastrointestinal tumors before surgery; Normal saline injection 50ml intravenously pumped 30 minutes before surgery	Drug: Normal saline; Intravenous acetaminophen was administered 30 minutes before anesthesia

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recovery time	The postoperative recovery time was recorded	immediately after the surgery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neurotransmitters in the blood	Neurotransmitters include epinephrine, norepinephrine, and so on	1/3/7 days after the surgery

Collaborators and Investigators

• Sponsor: Affiliated Hospital of Nantong University
• Investigators: Study Chair: Hongsheng Chen, Chair

Study record dates

Study Major Dates

• Study Start (Actual): July 26, 2023
• Primary Completion (Estimated): May 30, 2024
• Study Completion (Estimated): December 30, 2024

Study Registration Dates

• First Submitted: August 9, 2023
• First Submitted That Met QC Criteria: August 20, 2023
• First Posted (Actual): August 22, 2023

Study Record Updates

• Last Update Posted (Actual): August 22, 2023
• Last Update Submitted That Met QC Criteria: August 20, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: cognitive function; acetaminophen mannitol; anesthesia recovery time; gastrointestinal tumor surgery
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Antipyretics; Natriuretic Agents; Diuretics, Osmotic; Diuretics; Mannitol; Acetaminophen
• Other Study ID Numbers: zhhszjjh

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No