Cognitive FunctionPhase 1/2NCT06004687
Effect of Acetaminophen Preemptive Analgesia on Postoperative Cognitive Function
A Phase 1/2 study testing acetaminophen mannitol and Normal saline in people with Cognitive Function, run by Affiliated Hospital of Nantong University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 16 to 88 years
- Conditions the study is for
- Cognitive Function
- What is being tested?
- acetaminophen mannitol and Normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 26 Jul 2023to 30 Dec 2024
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 88 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients undergoing gastrointestinal tumor surgery
- American Society of Anesthesiologists（ASA）≤Ⅲ
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Chaochao Zhong contact
China1 site, 1 recruiting
- Recruiting
Affiliated Hospital of nantong University
Nantong, Jiangsu, 226001
Hongsheng Chen, +86 513 8116 0313
About this study
Official title: Effects of Acetaminophen Preemptive Analgesia on Anesthesia Recovery Time and Postoperative Cognitive Function in Patients Undergoing Gastrointestinal Tumor Surgery
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
Read the 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
- Conditions
- Cognitive Function
- Being tested
- acetaminophen mannitol, Normal saline
- Keywords
- acetaminophen mannitol, cognitive function, anesthesia recovery time, gastrointestinal tumor surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acetaminophen mannitolDrug
Intravenous acetaminophen was administered 30 minutes before anesthesia
Normal salineDrug
Intravenous acetaminophen was administered 30 minutes before anesthesia
| Study group | Role | What they receive |
|---|---|---|
| By applying acetaminophen mannitol to patients with gastrointestinal tumors before surgery | Active comparator | Acetaminophen mannitol injection 50ml(500mg) intravenously pumped 30 minutes before surgery Receives: 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 Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative delirium
The confusion assessment method (CAM) was used to assess postoperative cognitive dysfunction
Measured: 1/3/7 days after the surgery
Secondary outcomes (1)
Recovery time
The postoperative recovery time was recorded
Measured: immediately after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2023
- Study start26 Jul 2023
- Primary completion30 May 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive FunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Affiliated Hospital of Nantong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hongsheng Chen, Study chair, Chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06004687
- Sponsor's protocol ID
- zhhszjjh
- Status last verified
- Jul 2023
- First submitted
- 9 Aug 2023
- Last updated
- 22 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Acetaminophen Preemptive Analgesia on Anesthesia Recovery Time and Postoperative Cognitive Function in Patients Undergoing Gastrointestinal Tumor Surgery
- ClinicalTrials.gov ID
- NCT06004687
- Acronym / sponsor ID
- zhhszjjh
- Conditions
- Cognitive Function
- Keywords
- acetaminophen mannitol, cognitive function, anesthesia recovery time, gastrointestinal tumor surgery
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Affiliated Hospital of Nantong UniversityUniversity, hospital or other
- Study start
- 26 Jul 2023 (actual)
- Primary completion
- 30 May 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 22 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| By applying acetaminophen mannitol to patients with gastrointestinal tumors before surgery | Active comparator | Drug: acetaminophen mannitolAcetaminophen mannitol injection 50ml(500mg) intravenously pumped 30 minutes before surgery |
| By applying normal saline to patients with gastrointestinal tumors before surgery | Placebo comparator | Drug: Normal salineNormal saline injection 50ml intravenously pumped 30 minutes before surgery |
Who may qualify
- Ages
- 16 to 88 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients undergoing gastrointestinal tumor surgery
- American Society of Anesthesiologists（ASA）≤Ⅲ
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| acetaminophen mannitolIntravenous acetaminophen was administered 30 minutes before anesthesia | Drug | By applying acetaminophen mannitol to patients with gastrointestinal tumors before surgery |
| Normal salineIntravenous acetaminophen was administered 30 minutes before anesthesia | Drug | By applying normal saline to patients with gastrointestinal tumors before surgery |
Primary outcome
Postoperative delirium
Time frame: 1/3/7 days after the surgery
The confusion assessment method (CAM) was used to assess postoperative cognitive dysfunction
1 secondary outcome
Recovery time
Time frame: immediately after the surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chaochao Zhong contact
Hongsheng Chen study chair
Chair
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing acetaminophen mannitol and Normal saline in people with Cognitive Function, run by Affiliated Hospital of Nantong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hongsheng Chen (+86 513 81160313, chenhongsheng8@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative delirium (time frame: 1/3/7 days after the surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2023.