Effect of Acetaminophen Preemptive Analgesia on Postopera... | NCT06004687

Studies
Effect of Acetaminophen Preemptive Analgesia on Postoperative Cognitive Function

NCT06004687

Sponsor

Affiliated Hospital of Nantong University

Status

Unknown status

Last Update Posted

Aug 22, 2023Actual

Enrollment

100Estimated

Phase

Phase 1Phase 2

Conditions

Cognitive Function

Interventions

acetaminophen mannitol
Normal saline

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 26, 2023Actual

Primary Completion Date

May 30, 2024Estimated

Completion Date

Dec 30, 2024Estimated

First Submitted Date

Aug 9, 2023

First Submission Date that Met QC Criteria

Aug 20, 2023

First Posted Date

Aug 22, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 20, 2023

Last Update Posted Date

Aug 22, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
acetaminophen mannitol	Drug	Intravenous acetaminophen was administered 30 minutes before anesthesia	By applying acetaminophen mannitol to patients with gastrointestinal tumors before surgery

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Postoperative delirium	The confusion assessment method (CAM) was used to assess postoperative cognitive dysfunction	1/3/7 days after the surgery

Secondary Outcomes

Measure	Description	Time Frame
Recovery time	The postoperative recovery time was recorded	immediately after the surgery

Other Outcomes

Measure	Description	Time Frame
Neurotransmitters in the blood	Neurotransmitters include epinephrine, norepinephrine, and so on	1/3/7 days after the surgery

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

88 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Hongsheng Chen	Contact	+86 513 81160313		chenhongsheng8@163.com
Chaochao Zhong	Contact	+86 513 81160313

Overall Officials

Name	Affiliation	Role
Hongsheng Chen	Chair	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Affiliated Hospital of nantong University	Recruiting	Nantong	Jiangsu	226001	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077330	Saline Solution

Ancestor Terms

ID	Term
D000077324	Crystalloid Solutions
D007552	Isotonic Solutions
D012996	Solutions
D004364	Pharmaceutical Preparations

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Browse Branches

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