General Anesthesia Using Endotracheal IntubationNCT06632067
Sugammadex and Time to Extubation in Ophthalmic Surgery
An observational study of General Anesthesia Using Endotracheal Intubation and Ophthalmologic Surgical Procedure, run by China Medical University Hospital at 1 site in Taiwan.
Trial summary
This study is to invastigate if patients treated with sugammadex compared to neostigmine/atropine would be extubate faster upon emergence of anesthesia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- General Anesthesia Using Endotracheal Intubation, Ophthalmologic Surgical Procedure, Sugammadex
- What is being tested?
- sugammadex and Neostigmine + Atropine
- How many people
- 262 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Aug 2023to 31 Aug 2023
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study included patients aged 18 years or older who underwent ophthalmic surgeries under general anesthesia with tracheal intubation between 2020 and 2022. Patients who received rocuronium as the sole neuromuscular blocking agent and were maintained with sevoflurane or desflurane and intravenous fentanyl were included. Based on the choice of reversal agent for neuromuscular blockade, patients were divided into two groups: the sugammadex group or the neostigmine group. Patients who underwent emergency surgery or combined surgeries with other specialties were excluded.
Who may be able to join
- aged 18 years or older ophthalmic surgeries under general anesthesia with tracheal intubation between 2020 and 2022 received rocuronium as the sole neuromuscular blocking agent maintained with sevoflurane or desflurane and intravenous fentanyl
Who cannot join
- emergency surgery combined surgeries with other specialties
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Sugammadex and Neostigmine for Time to Extubation in Adult Patients Undergoing Routine Ophthalmic Surgery Under General Anesthesia
This study is to invastigate if patients treated with sugammadex compared to neostigmine/atropine would be extubate faster upon emergence of anesthesia.
Read the detailed description
This is a retrospective case-control study including patients aged 18 years or older who underwent ophthalmic surgeries under general anesthesia with tracheal intubation between 2020 and 2022. Patients who received rocuronium as the sole neuromuscular blocking agent and were maintained with sevoflurane or desflurane and intravenous fentanyl were included. Based on the choice of reversal agent for neuromuscular blockade, patients were divided into two groups: the sugammadex group or the neostigmine group. Patients who underwent emergency surgery or combined surgeries with other specialties were excluded. Patient characteristics, including age, gender, ASA classification, weight, and height, were collected. Anesthesia-related medications were recorded. The time points of anesthesia induction, start and end of surgery, reversal agent administration, and tracheal extubation were documented.
- Conditions
- General Anesthesia Using Endotracheal Intubation, Ophthalmologic Surgical Procedure, Sugammadex, Neostigmine, Extubation Readiness
- Being tested
- sugammadex, Neostigmine + Atropine
- Keywords
- sugammadex, general anesthesia, ophthalmologic surgical procedures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sugammadexDrug
sugammadex used for neuromuscular reversal
Neostigmine + AtropineDrug
Neostigmine and Atropine used for neuromuscular reversal
| Study group | Role | What they receive |
|---|---|---|
| sugammadex | those who use sugammadex for reversal of neuromuscular blockade Receives: Drug: sugammadex | |
| neostigmine | those who use neostigmine/atroping for reversal of neuromuscular blockade Receives: Drug: Neostigmine + Atropine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time From reversal to extubation
Time From reversal to extubation
Measured: Time From reversal to extubation
Time From the end of surgery to reversal
Time From the end of surgery to reversal
Measured: Time From the end of surgery to reversal
Secondary outcomes (1)
Time From induction to the end of surgery
Time From induction to the end of surgery
Measured: Time From induction to the end of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study start1 Aug 2023
- Primary completion31 Aug 2023
- Study completion31 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for General Anesthesia Using Endotracheal IntubationStudies of the same condition, open and under way.
- More trials run by China Medical University HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 262 participants (actual)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yi-Ying Chiang, MD, Principal investigator, China Medical Univerity Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06632067
- Sponsor's protocol ID
- CMUH112-REC3-124
- Status last verified
- Oct 2024
- First submitted
- 6 Oct 2024
- Last updated
- 8 Oct 2024
- 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 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Sugammadex and Neostigmine for Time to Extubation in Adult Patients Undergoing Routine Ophthalmic Surgery Under General Anesthesia
- ClinicalTrials.gov ID
- NCT06632067
- Acronym / sponsor ID
- CMUH112-REC3-124
- Conditions
- General Anesthesia Using Endotracheal Intubation, Ophthalmologic Surgical Procedure, Sugammadex, Neostigmine, Extubation Readiness
- Keywords
- sugammadex, general anesthesia, ophthalmologic surgical procedures
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 262 participants (actual)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 8 Oct 2024 (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.
This study is to invastigate if patients treated with sugammadex compared to neostigmine/atropine would be extubate faster upon emergence of anesthesia.
Detailed description
This is a retrospective case-control study including patients aged 18 years or older who underwent ophthalmic surgeries under general anesthesia with tracheal intubation between 2020 and 2022. Patients who received rocuronium as the sole neuromuscular blocking agent and were maintained with sevoflurane or desflurane and intravenous fentanyl were included. Based on the choice of reversal agent for neuromuscular blockade, patients were divided into two groups: the sugammadex group or the neostigmine group. Patients who underwent emergency surgery or combined surgeries with other specialties were excluded. Patient characteristics, including age, gender, ASA classification, weight, and height, were collected. Anesthesia-related medications were recorded. The time points of anesthesia induction, start and end of surgery, reversal agent administration, and tracheal extubation were documented.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sugammadex | – | Drug: sugammadexthose who use sugammadex for reversal of neuromuscular blockade |
| neostigmine | – | Drug: Neostigmine + Atropinethose who use neostigmine/atroping for reversal of neuromuscular blockade |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study included patients aged 18 years or older who underwent ophthalmic surgeries under general anesthesia with tracheal intubation between 2020 and 2022. Patients who received rocuronium as the sole neuromuscular blocking agent and were maintained with sevoflurane or desflurane and intravenous fentanyl were included. Based on the choice of reversal agent for neuromuscular blockade, patients were divided into two groups: the sugammadex group or the neostigmine group. Patients who underwent emergency surgery or combined surgeries with other specialties were excluded.
Key inclusion criteria (1 listed)
- aged 18 years or older ophthalmic surgeries under general anesthesia with tracheal intubation between 2020 and 2022 received rocuronium as the sole neuromuscular blocking agent maintained with sevoflurane or desflurane and intravenous fentanyl
Key exclusion criteria (1 listed)
- emergency surgery combined surgeries with other specialties
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 |
|---|---|---|
| sugammadexsugammadex used for neuromuscular reversal | Drug | sugammadex |
| Neostigmine + AtropineNeostigmine and Atropine used for neuromuscular reversal | Drug | neostigmine |
Primary outcome
Time From reversal to extubation
Time frame: Time From reversal to extubation
Time From reversal to extubation
Time From the end of surgery to reversal
Time frame: Time From the end of surgery to reversal
Time From the end of surgery to reversal
1 secondary outcome
Time From induction to the end of surgery
Time frame: Time From induction to the end of surgery
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 8 Oct 2024.
- 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.
Yi-Ying Chiang, MD principal investigator
China Medical Univerity Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of General Anesthesia Using Endotracheal Intubation and Ophthalmologic Surgical Procedure, run by China Medical University Hospital at 1 site in Taiwan.
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 8 Oct 2024. 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 Taiwan. 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?
Time From reversal to extubation (time frame: Time From reversal to extubation). The study lists 2 primary outcomes in all. 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 8 Oct 2024; AzTrials last refreshed its copy on 7 Nov 2026.