Gastric CancerNCT06123637
Analgesia Nociception Index-guided Anesthesia and Standard Anesthesia
A study testing Analgesia nociception index-guided anesthesia and Standard anesthesia in people with Gastric Cancer, run by Ajou University School of Medicine.
Trial summary
The primary purpose of this study is to compare the analgesia nociception index-guided anesthesia and standard anesthesia on remifentanil requirement in desflurane anesthesia. Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- Analgesia nociception index-guided anesthesia and Standard anesthesia
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- No sites listed yet
- Study dates
- 2 Jan 2024to 30 Dec 2024
- Phase
- Interventional
- 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 20 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of gastric cancer
Who cannot join
- Conversion to open laparotomy
- Prior opioid abuse
- Prior infection
- Cardiac arrythmia
About this study
Official title: Comparison of Analgesia Nociception Index-guided Anesthesia and Standard Anesthesia on Remifentanil Requirement in Desflurane Anesthesia
The primary purpose of this study is to compare the analgesia nociception index-guided anesthesia and standard anesthesia on remifentanil requirement in desflurane anesthesia.
- Conditions
- Gastric Cancer
- Being tested
- Analgesia nociception index-guided anesthesia, Standard anesthesia
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Analgesia nociception index-guided anesthesiaBehavioural
Maintaining the blood pressure based on analgesia nociception index of >50 value
Standard anesthesiaBehavioural
Maintaining the blood pressure based on anesthesiologist's decision
| Study group | Role | What they receive |
|---|---|---|
| Analgesia nociception index group | Experimental | Not described Receives: Behavioral: Analgesia nociception index-guided anesthesia |
| Standard group | Placebo comparator | Not described Receives: Behavioral: Standard anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Remifentanil requirement
Assessing the total dose of remifentanil administered from skin incision until skin suture
Measured: at time of the end of skin suture (up to 4 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2023
- Study start2 Jan 2024 (estimated)
- Primary completion30 Dec 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 Gastric CancerStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ajou University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ji Eun Kim, Ajou University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06123637
- Sponsor's protocol ID
- AJOUIRB-IV-2023-389
- Status last verified
- Nov 2023
- First submitted
- 1 Nov 2023
- Last updated
- 9 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Analgesia Nociception Index-guided Anesthesia and Standard Anesthesia on Remifentanil Requirement in Desflurane Anesthesia
- ClinicalTrials.gov ID
- NCT06123637
- Acronym / sponsor ID
- AJOUIRB-IV-2023-389
- Conditions
- Gastric Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Ajou University School of MedicineUniversity, hospital or other
- Study start
- 2 Jan 2024 (estimated)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 9 Nov 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.
The primary purpose of this study is to compare the analgesia nociception index-guided anesthesia and standard anesthesia on remifentanil requirement in desflurane anesthesia.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Analgesia nociception index group | Experimental | Behavioral: Analgesia nociception index-guided anesthesia |
| Standard group | Placebo comparator | Behavioral: Standard anesthesia |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Clinical diagnosis of gastric cancer
Key exclusion criteria (4 listed)
- Conversion to open laparotomy
- Prior opioid abuse
- Prior infection
- Cardiac arrythmia
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 |
|---|---|---|
| Analgesia nociception index-guided anesthesiaMaintaining the blood pressure based on analgesia nociception index of >50 value | Behavioural | Analgesia nociception index group |
| Standard anesthesiaMaintaining the blood pressure based on anesthesiologist's decision | Behavioural | Standard group |
Primary outcome
Remifentanil requirement
Time frame: at time of the end of skin suture (up to 4 hours)
Assessing the total dose of remifentanil administered from skin incision until skin suture
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Analgesia nociception index-guided anesthesia and Standard anesthesia in people with Gastric Cancer, run by Ajou University School of Medicine.
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 1 inclusion and 4 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 9 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Remifentanil requirement (time frame: at time of the end of skin suture (up to 4 hours)). 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 9 Nov 2023.