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Trial Title:
Effect of Acetaminophen Preemptive Analgesia on Postoperative Cognitive Function
NCT ID:
NCT06004687
Condition:
Cognitive Function
Conditions: Official terms:
Acetaminophen
Mannitol
Conditions: Keywords:
acetaminophen mannitol
cognitive function
anesthesia recovery time
gastrointestinal tumor surgery
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Prevention
Masking:
Single (Investigator)
Intervention:
Intervention type:
Drug
Intervention name:
acetaminophen mannitol
Description:
Intravenous acetaminophen was administered 30 minutes before anesthesia
Arm group label:
By applying acetaminophen mannitol to patients with gastrointestinal tumors before surgery
Intervention type:
Drug
Intervention name:
Normal saline
Description:
Intravenous acetaminophen was administered 30 minutes before anesthesia
Arm group label:
By applying normal saline to patients with gastrointestinal tumors before surgery
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
Criteria for 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
Gender:
All
Minimum age:
16 Years
Maximum age:
88 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Affiliated Hospital of nantong University
Address:
City:
Nantong
Zip:
226001
Country:
China
Status:
Recruiting
Contact:
Last name:
Hongsheng Chen
Phone:
+86 513 8116 0313
Start date:
July 26, 2023
Completion date:
December 30, 2024
Lead sponsor:
Agency:
Affiliated Hospital of Nantong University
Agency class:
Other
Source:
Affiliated Hospital of Nantong University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06004687
