Clinical trial

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

Name

zhhszjjh

Description

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

Trial arms

Trial start

2023-07-26

Estimated PCD

2024-05-30

Trial end

2024-12-30

Status

Recruiting

Phase

Early phase I

Treatment

acetaminophen mannitol

Intravenous acetaminophen was administered 30 minutes before anesthesia

Arms:

By applying acetaminophen mannitol to patients with gastrointestinal tumors before surgery

Normal saline

Intravenous acetaminophen was administered 30 minutes before anesthesia

Arms:

By applying normal saline to patients with gastrointestinal tumors before surgery

Size

100

Primary endpoint

Postoperative delirium

1/3/7 days after the surgery

Eligibility criteria

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}}, 'enrollmentInfo': {'count': 100, 'type': 'ESTIMATED'}}

Updated at

2023-08-22

1 organization

1 product

1 drug

1 indication

Organization

Affiliated Hospital of Nantong University

Product

Acetaminophen

Indication

Cognitive Function

Drug

Varlilumab