Effect of Acetaminophen Preemptive Analgesia on Postoperative Cognitive Function

Affiliated Hospital of Nantong University

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Cognitive Function

Treatments: Drug: acetaminophen mannitol; Drug: Normal saline

Study type: Interventional

Funder types: Other

Identifiers

NCT06004687

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Details and patient eligibility

About

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

Full 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

Enrollment: 100 estimated patients

Sex: All

Ages: 16 to 88 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups, including a placebo group

By applying acetaminophen mannitol to patients with gastrointestinal tumors before surgery

Active Comparator group

Description:

Acetaminophen mannitol injection 50ml(500mg) intravenously pumped 30 minutes before surgery

Treatment:

Drug: acetaminophen mannitol

By applying normal saline to patients with gastrointestinal tumors before surgery

Placebo Comparator group

Description:

Normal saline injection 50ml intravenously pumped 30 minutes before surgery

Treatment:

Drug: Normal saline