Gallbladder DiseasesNCT03583021
Sugammadex on Remifentanil Ce for Preventing Emergence Cough in Male
A study testing Sugammadex Injectable Product and Neostigmine Injectable Product in people with Gallbladder Diseases, run by Ajou University School of Medicine at 1 site in South Korea.
Trial summary
The primary purpose of this study is to investigate the optimal Ce of remifentanil for preventing emergence cough following extubation during general anesthesia in male patients who are reversed with sugammadex or neostigmine. Read more about this study
- Who is it for?
- Ages 65 to 80 years, men only
- Conditions the study is for
- Gallbladder Diseases
- What is being tested?
- Sugammadex Injectable Product and Neostigmine Injectable Product
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteSouth Korea
- Study dates
- 25 Jun 2018to 31 Dec 2018
- 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 65 to 80 years
- Men only
- No healthy volunteers
- Older adult
Who may be able to join
- Laparoscopic cholecystectomy under general anesthesia
Who cannot join
- BMI > 30 kg/m2, respiratory infection, uncontrolled hypertension
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Anesthesiology and Pain Medicine, Ajou University School of Medicine
Suwon, Seoul
About this study
Official title: Department of Anesthesiology and Pain Medicine, Ajou University School of Medicine
The primary purpose of this study is to investigate the optimal Ce of remifentanil for preventing emergence cough following extubation during general anesthesia in male patients who are reversed with sugammadex or neostigmine.
Read the detailed description
Remifentanil is a potent ultrashort-acting opioid, with rapid onset and offset of drug effect. It allows rapid anesthetic emergence even after a prolonged infusion, and decreases the at-risk time during extubation. In addition, cough suppression of remifentanil enables smooth extubation with reduced complications. However, the infusion of remifentanil suppresses the emergence cough effectively in clinical practice, whereas it still delays the awakening from anesthesia, resulting in prolonged emergence time. Reduced Ce of remifentanil during emergence would decrease the adverse events that are associated with remifentanil infusion.
- Conditions
- Gallbladder Diseases
- Being tested
- Sugammadex Injectable Product, Neostigmine Injectable Product
- Medical subject headings
- Gallbladder Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sugammadex Injectable ProductDrug
Sugammadex of 3 mg/kg is injected.
Neostigmine Injectable ProductDrug
Neostigmine of 50 ug/kg and Glycopyrrolate of 10 ug/kg are injected.
| Study group | Role | What they receive |
|---|---|---|
| sugammadex group | Experimental | Sugammadex group receives the intravenous sugammadex of 3 mg/kg. Receives: Drug: Sugammadex Injectable Product |
| neostigmine group | Placebo comparator | Neostigmine group receives the intravenous neostigmine 50 ug/kg and glycopyrrolate 10 ug/kg. Receives: Drug: Neostigmine Injectable Product |
What is being measured
The primary outcome is the main question the study is designed to answer.
optimal Ce of remifentanil
Using Dixon methods, evaluating of optimal Ce of remifentanil for preventing emergence cough following extubation during general anesthesia
Measured: from the ene of surgery until endotracheal extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2018
- Study start25 Jun 2018
- Primary completion31 Oct 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gallbladder 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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 42 participants (actual)
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
- Investigators
- Ji Eun Kim, Principal investigator, Ajou University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03583021
- Sponsor's protocol ID
- AJIRB-MED-OBS-18-105
- Status last verified
- May 2020
- First submitted
- 28 Jun 2018
- Last updated
- 29 May 2020
- 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 29 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Department of Anesthesiology and Pain Medicine, Ajou University School of Medicine
- ClinicalTrials.gov ID
- NCT03583021
- Acronym / sponsor ID
- AJIRB-MED-OBS-18-105
- Conditions
- Gallbladder Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Ajou University School of MedicineUniversity, hospital or other
- Study start
- 25 Jun 2018 (actual)
- Primary completion
- 31 Oct 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 11 Jul 2018 (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 investigate the optimal Ce of remifentanil for preventing emergence cough following extubation during general anesthesia in male patients who are reversed with sugammadex or neostigmine.
Detailed description
Remifentanil is a potent ultrashort-acting opioid, with rapid onset and offset of drug effect. It allows rapid anesthetic emergence even after a prolonged infusion, and decreases the at-risk time during extubation. In addition, cough suppression of remifentanil enables smooth extubation with reduced complications. However, the infusion of remifentanil suppresses the emergence cough effectively in clinical practice, whereas it still delays the awakening from anesthesia, resulting in prolonged emergence time. Reduced Ce of remifentanil during emergence would decrease the adverse events that are associated with remifentanil infusion.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sugammadex group | Experimental | Drug: Sugammadex Injectable ProductSugammadex group receives the intravenous sugammadex of 3 mg/kg. |
| neostigmine group | Placebo comparator | Drug: Neostigmine Injectable ProductNeostigmine group receives the intravenous neostigmine 50 ug/kg and glycopyrrolate 10 ug/kg. |
Who may qualify
- Ages
- 65 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Laparoscopic cholecystectomy under general anesthesia
Key exclusion criteria (1 listed)
- BMI > 30 kg/m2, respiratory infection, uncontrolled hypertension
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 |
|---|---|---|
| Sugammadex Injectable ProductSugammadex of 3 mg/kg is injected. | Drug | sugammadex group |
| Neostigmine Injectable ProductNeostigmine of 50 ug/kg and Glycopyrrolate of 10 ug/kg are injected. | Drug | neostigmine group |
Primary outcome
optimal Ce of remifentanil
Time frame: from the ene of surgery until endotracheal extubation
Using Dixon methods, evaluating of optimal Ce of remifentanil for preventing emergence cough following extubation during general anesthesia
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 29 May 2020.
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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.
Ji Eun Kim principal investigator
Ajou University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sugammadex Injectable Product and Neostigmine Injectable Product in people with Gallbladder Diseases, run by Ajou University School of Medicine 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 1 inclusion and 1 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 29 May 2020. 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. 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?
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?
optimal Ce of remifentanil (time frame: from the ene of surgery until endotracheal extubation). 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 29 May 2020.