Anterior Cervical Discectomy and Fusion (ACDF) SurgeryNCT05019222
Comparison of Postoperative QoR-15 Scores Between Sevoflurane and Remimazolam
A study testing Sevoflurane based inhalation anesthesia and Remimazolam based total intravenous anesthesia in people with Anterior Cervical Discectomy and Fusion (ACDF) Surgery, run by Gangnam Severance Hospital at 1 site in South Korea.
Trial summary
The purpose of the study is to compare the quality of recovery (QoR)-15 scores according to the use of maintenance anesthetics in the cervical spine surgery. Total intravenous anesthesia (TIVA) have been known to help reducing risks of postoperative nausea/vomiting and malignant hyperthermia. Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Anterior Cervical Discectomy and Fusion (ACDF) Surgery
- What is being tested?
- Sevoflurane based inhalation anesthesia and Remimazolam based total intravenous anesthesia
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteSouth Korea
- Study dates
- 26 Sep 2021to 14 Aug 2022
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult patients who aged 20-70 years
- ASA-PS: 1-3
- BMI < 30
- Anterior cervical discectomy and fusion surgery
Who cannot join
- Tolerance or hypersensitivity to benzodiazepine
- Dependence or addiction to psychotropic drugs or alcohol
- Pregnant women, subjects who lack the ability to make decisions and susceptible to voluntary participation decisions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Quality of Recovery (QoR)-15 Scores According to the Use of Anesthetics During General Anesthesia in the Cervical Spine Surgery Patients: Sevoflurane vs. Remimazolam
The purpose of the study is to compare the quality of recovery (QoR)-15 scores according to the use of maintenance anesthetics in the cervical spine surgery. Total intravenous anesthesia (TIVA) have been known to help reducing risks of postoperative nausea/vomiting and malignant hyperthermia. However, it is still not enough to explain which is better between TIVA or inhalation anesthesia. In particular, there is no study to investigate overall postoperative functional recovery via QoR-15 in patients receiving TIVA with remimazolam. The hypothesis of the investigators study is that, in patients with cervical spine surgery, total intravenous anesthesia based on remimazolam can improve the the quality of recovery compared to inhalation anesthesia based on sevoflurane.
- Being tested
- Sevoflurane based inhalation anesthesia, Remimazolam based total intravenous anesthesia
- Keywords
- Cervical surgery, Quality of Recovery, Remimazolam, sevoflurane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sevoflurane based inhalation anesthesiaDrug
Sevoflurane group will be inducted with bolus of propofol 1% and maintained with sevofulrane as inhalation and TCI Minto model of remifentanil for general anesthesia.
Remimazolam based total intravenous anesthesiaDrug
Remimazolam group will be inducted with remiamazolam at 6 mg/kg/h and maintained with remimazolam at 0.5-1.5 mg/kg/h and TCI Minto model of remifentanil for general anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1) Sevoflurane group | Experimental | Sevoflurane based inhalation anesthesia Receives: Drug: Sevoflurane based inhalation anesthesia |
| Arm 2) Remimazolam group | Active comparator | Remimazolam based total intravenous anesthesia Receives: Drug: Remimazolam based total intravenous anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference between two groups (sevoflurane vs. remimazolam) in QoR-15 scores
The difference of scores in the Quality of Recovery (QoR)-15 survey on POD 1 Total 0-150, 0 (minimum), 150 (maximum), Higher scores means better.
Measured: postoperative day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2021
- Study start26 Sep 2021
- Primary completion14 Aug 2022
- Study completion14 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Cervical Discectomy and Fusion (ACDF) SurgeryStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gangnam Severance Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Myoung Hwa Kim, Gangnam Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05019222
- Sponsor's protocol ID
- 3-2021- 0257
- Status last verified
- Apr 2023
- First submitted
- 19 Aug 2021
- Last updated
- 25 Apr 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 25 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Quality of Recovery (QoR)-15 Scores According to the Use of Anesthetics During General Anesthesia in the Cervical Spine Surgery Patients: Sevoflurane vs. Remimazolam
- ClinicalTrials.gov ID
- NCT05019222
- Acronym / sponsor ID
- 3-2021- 0257
- Keywords
- Cervical surgery, Quality of Recovery, Remimazolam, sevoflurane
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Gangnam Severance HospitalUniversity, hospital or other
- Study start
- 26 Sep 2021 (actual)
- Primary completion
- 14 Aug 2022 (actual)
- Study completion
- 14 Aug 2022 (actual)
- First posted
- 24 Aug 2021 (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 purpose of the study is to compare the quality of recovery (QoR)-15 scores according to the use of maintenance anesthetics in the cervical spine surgery. Total intravenous anesthesia (TIVA) have been known to help reducing risks of postoperative nausea/vomiting and malignant hyperthermia. However, it is still not enough to explain which is better between TIVA or inhalation anesthesia. In particular, there is no study to investigate overall postoperative functional recovery via QoR-15 in patients receiving TIVA with remimazolam. The hypothesis of the investigators study is that, in patients with cervical spine surgery, total intravenous anesthesia based on remimazolam can improve the the quality of recovery compared to inhalation anesthesia based on sevoflurane.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1) Sevoflurane group | Experimental | Drug: Sevoflurane based inhalation anesthesiaSevoflurane based inhalation anesthesia |
| Arm 2) Remimazolam group | Active comparator | Drug: Remimazolam based total intravenous anesthesiaRemimazolam based total intravenous anesthesia |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients who aged 20-70 years
- ASA-PS: 1-3
- BMI < 30
- Anterior cervical discectomy and fusion surgery
Key exclusion criteria (3 listed)
- Tolerance or hypersensitivity to benzodiazepine
- Dependence or addiction to psychotropic drugs or alcohol
- Pregnant women, subjects who lack the ability to make decisions and susceptible to voluntary participation decisions
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 |
|---|---|---|
| Sevoflurane based inhalation anesthesiaSevoflurane group will be inducted with bolus of propofol 1% and maintained with sevofulrane as inhalation and TCI Minto model of remifentanil for general anesthesia. | Drug | Arm 1) Sevoflurane group |
| Remimazolam based total intravenous anesthesiaRemimazolam group will be inducted with remiamazolam at 6 mg/kg/h and maintained with remimazolam at 0.5-1.5 mg/kg/h and TCI Minto model of remifentanil for general anesthesia. | Drug | Arm 2) Remimazolam group |
Primary outcome
The difference between two groups (sevoflurane vs. remimazolam) in QoR-15 scores
Time frame: postoperative day 1
The difference of scores in the Quality of Recovery (QoR)-15 survey on POD 1 Total 0-150, 0 (minimum), 150 (maximum), Higher scores means better.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sevoflurane based inhalation anesthesia and Remimazolam based total intravenous anesthesia in people with Anterior Cervical Discectomy and Fusion (ACDF) Surgery, run by Gangnam Severance Hospital at 1 site in South Korea.
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 4 inclusion and 3 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: finished, as of the sponsor's last update on 25 Apr 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 South Korea. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The difference between two groups (sevoflurane vs. remimazolam) in QoR-15 scores (time frame: postoperative day 1). 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 25 Apr 2023.