NCT06004687

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jul 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 26, 2023

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

August 9, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

August 22, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2024

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
Last Updated

August 22, 2023

Status Verified

July 1, 2023

Enrollment Period

10 months

First QC Date

August 9, 2023

Last Update Submit

August 20, 2023

Conditions

Cognitive Function

Keywords

acetaminophen mannitolcognitive functionanesthesia recovery timegastrointestinal tumor surgery

Outcome Measures

Primary Outcomes (1)

  • Postoperative delirium

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

    1/3/7 days after the surgery

Secondary Outcomes (1)

  • Recovery time

    immediately after the surgery

Other Outcomes (1)

  • Neurotransmitters in the blood

    1/3/7 days after the surgery

Study Arms (2)

By applying acetaminophen mannitol to patients with gastrointestinal tumors before surgery

ACTIVE COMPARATOR

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

Drug: acetaminophen mannitol

By applying normal saline to patients with gastrointestinal tumors before surgery

PLACEBO COMPARATOR

Normal saline injection 50ml intravenously pumped 30 minutes before surgery

Drug: Normal saline

Interventions

acetaminophen mannitolDRUG

Intravenous acetaminophen was administered 30 minutes before anesthesia

By applying acetaminophen mannitol to patients with gastrointestinal tumors before surgery
Normal salineDRUG

Intravenous acetaminophen was administered 30 minutes before anesthesia

By applying normal saline to patients with gastrointestinal tumors before surgery

Eligibility Criteria

Age16 Years - 88 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing gastrointestinal tumor surgery
  • American Society of Anesthesiologists（ASA）≤Ⅲ

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Affiliated Hospital of nantong University

Nantong, Jiangsu, 226001, China

RECRUITING

MeSH Terms

Interventions

Saline Solution

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Hongsheng Chen

    Chair

    STUDY CHAIR

Central Study Contacts

Hongsheng Chen

CONTACT

+86 513 81160313chenhongsheng8@163.com

Chaochao Zhong

CONTACT

+86 513 81160313

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 9, 2023

First Posted

August 22, 2023

Study Start

July 26, 2023

Primary Completion

May 30, 2024

Study Completion

December 30, 2024

Last Updated

August 22, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)