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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06004687
Other study ID # zhhszjjh
Secondary ID
Status Recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date July 26, 2023
Est. completion date December 30, 2024

Study information

Verified date July 2023
Source Affiliated Hospital of Nantong University
Contact Hongsheng Chen
Phone +86 513 81160313
Email chenhongsheng8@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date December 30, 2024
Est. primary completion date May 30, 2024
Accepts healthy volunteers No
Gender All
Age group 16 Years to 88 Years
Eligibility Inclusion Criteria: - Patients undergoing gastrointestinal tumor surgery - American Society of Anesthesiologists(ASA)=? 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


Related Conditions & MeSH terms


Intervention

Drug:
acetaminophen mannitol
Intravenous acetaminophen was administered 30 minutes before anesthesia
Normal saline
Intravenous acetaminophen was administered 30 minutes before anesthesia

Locations

Country Name City State
China Affiliated Hospital of nantong University Nantong Jiangsu

Sponsors (1)

Lead Sponsor Collaborator
Affiliated Hospital of Nantong University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Other Neurotransmitters in the blood Neurotransmitters include epinephrine, norepinephrine, and so on 1/3/7 days after the surgery
Primary Postoperative delirium The confusion assessment method (CAM) was used to assess postoperative cognitive dysfunction 1/3/7 days after the surgery
Secondary Recovery time The postoperative recovery time was recorded immediately after the surgery
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