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Effect of Acetaminophen Preemptive Analgesia on Postoperative Cognitive Function

Sponsor
Affiliated Hospital of Nantong University (Other)
Overall Status
Recruiting
CT.gov ID
NCT06004687
Collaborator
(none)
100
Enrollment
1
Location
2
Arms
17.2
Anticipated Duration (Months)
5.8
Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease Intervention/Treatment Phase
  • Drug: acetaminophen mannitol
  • Drug: Normal saline
 Phase 1/Phase 2

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 Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Investigator)
Primary Purpose:
Prevention
Official Title:
Effects of Acetaminophen Preemptive Analgesia on Anesthesia Recovery Time and Postoperative Cognitive Function in Patients Undergoing Gastrointestinal Tumor Surgery
Actual Study Start Date :
Jul 26, 2023
Anticipated Primary Completion Date :
May 30, 2024
Anticipated Study Completion Date :
Dec 30, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Postoperative delirium [1/3/7 days after the surgery]

    The confusion assessment method (CAM) was used to assess postoperative cognitive dysfunction

Secondary Outcome Measures

  1. Recovery time [immediately after the surgery]

    The postoperative recovery time was recorded

Other Outcome Measures

  1. Neurotransmitters in the blood [1/3/7 days after the surgery]

    Neurotransmitters include epinephrine, norepinephrine, and so on

Eligibility Criteria

Criteria

Ages Eligible for Study:
16 Years to 88 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Affiliated Hospital of nantong University Nantong Jiangsu China 226001

Sponsors and Collaborators

  • Affiliated Hospital of Nantong University

Investigators

  • Study Chair: Hongsheng Chen, Chair

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Affiliated Hospital of Nantong University
ClinicalTrials.gov Identifier:
NCT06004687
Other Study ID Numbers:
  • zhhszjjh
First Posted:
Aug 22, 2023
Last Update Posted:
Aug 22, 2023
Last Verified:
Jul 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Affiliated Hospital of Nantong University
acetaminophen mannitol
cognitive function
anesthesia recovery time
gastrointestinal tumor surgery
Additional relevant MeSH terms:
Acetaminophen
Mannitol

Study Results

No Results Posted as of Aug 22, 2023