Spinal DiseasesNCT06123624
Desflurane and Sevoflurane on Remifentanil Requirement
A study testing Desflurane Inhalation Solution and Sevoflurane Inhalation Solution in people with Spinal Diseases, run by Ajou University School of Medicine.
Trial summary
The primary purpose of this study is to compare the desflurane and sevoflurane on remifentanil requirement using analgesia nociception index-guided anesthesia in patients undergoing spine surgery. Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Spinal Diseases
- What is being tested?
- Desflurane Inhalation Solution and Sevoflurane Inhalation Solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 78 participants
- Where
- No sites listed yet
- Study dates
- 27 Nov 2023to 30 Aug 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 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of herniated disc, injury of spinal cord, and neoplasm of spinal meninges
Who cannot join
- Hyperbilirubinemia
- Prior chronic pain
- Prior opioid abuse
- Cardiac arrythmia
About this study
Official title: Comparison of Desflurane and Sevoflurane on Remifentanil Requirement Using Analgesia Nociception Index-guided Anesthesia
The primary purpose of this study is to compare the desflurane and sevoflurane on remifentanil requirement using analgesia nociception index-guided anesthesia in patients undergoing spine surgery.
- Conditions
- Spinal Diseases
- Being tested
- Desflurane Inhalation Solution, Sevoflurane Inhalation Solution
- Medical subject headings
- Spinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Desflurane Inhalation SolutionDrug
Keeping the anesthesia using desflurane inhalation solution as 1 minimal alveolar concentration
Sevoflurane Inhalation SolutionDrug
Keeping the anesthesia using sevoflurane inhalation solution as 1 minimal alveolar concentration
| Study group | Role | What they receive |
|---|---|---|
| Desflurane group | Experimental | Not described Receives: Drug: Desflurane Inhalation Solution |
| Sevoflurane group | Placebo comparator | Not described Receives: Drug: Sevoflurane Inhalation Solution |
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 3 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 start27 Nov 2023 (estimated)
- Primary completion30 Aug 2024 (estimated)
- Study completion30 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal DiseasesStudies 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
- 78 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
- NCT06123624
- Sponsor's protocol ID
- AJOUIRB-IV-2023-380
- 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 Desflurane and Sevoflurane on Remifentanil Requirement Using Analgesia Nociception Index-guided Anesthesia
- ClinicalTrials.gov ID
- NCT06123624
- Acronym / sponsor ID
- AJOUIRB-IV-2023-380
- Conditions
- Spinal Diseases
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Ajou University School of MedicineUniversity, hospital or other
- Study start
- 27 Nov 2023 (estimated)
- Primary completion
- 30 Aug 2024 (estimated)
- Study completion
- 30 Aug 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 desflurane and sevoflurane on remifentanil requirement using analgesia nociception index-guided anesthesia in patients undergoing spine surgery.
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 |
|---|---|---|
| Desflurane group | Experimental | Drug: Desflurane Inhalation Solution |
| Sevoflurane group | Placebo comparator | Drug: Sevoflurane Inhalation Solution |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Clinical diagnosis of herniated disc, injury of spinal cord, and neoplasm of spinal meninges
Key exclusion criteria (4 listed)
- Hyperbilirubinemia
- Prior chronic pain
- Prior opioid abuse
- 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 |
|---|---|---|
| Desflurane Inhalation SolutionKeeping the anesthesia using desflurane inhalation solution as 1 minimal alveolar concentration | Drug | Desflurane group |
| Sevoflurane Inhalation SolutionKeeping the anesthesia using sevoflurane inhalation solution as 1 minimal alveolar concentration | Drug | Sevoflurane group |
Primary outcome
remifentanil requirement
Time frame: at time of the end of skin suture (up to 3 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 Desflurane Inhalation Solution and Sevoflurane Inhalation Solution in people with Spinal Diseases, 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 3 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.