SugammadexPhase 4NCT06081738
Neostigmine Versus Sugammadex on Renal Functions
A Phase 4 study testing Neostigmine and Sugammadex in people with Sugammadex and Neostigmine, run by Menoufia University at 1 site in Egypt.
Trial summary
The study will assess the acute effects of sugammadex or neostigmine on renal function as determined with more specific and sensitive tests in laparoscopic cholecystectomy Read more about this study
- Who is it for?
- Ages 20 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Sugammadex, Neostigmine
- What is being tested?
- Neostigmine and Sugammadex
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2023to 31 Dec 2023
- Phase
- Phase 4
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- normal renal function (serum Cr 0.4- 1.4 g/dL)
- American Society of Anesthesiologists (ASA) Class I-II
Who cannot join
- Incapacity to consent.
- Pre-existing impaired kidney functions.
- Severe neuromuscular disease, as: myasthenia gravis \& muscular dystrophy.
- Intra-operative bleeding
- Lengthy operations that exceed 2 hours.
- Hemodynamic changes more than 20% of the base line
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of The Effects of Neostigmine Versus Sugammadex on Renal Functions in Laparoscopic Cholecystecomy A Randomized Controlled Study
The study will assess the acute effects of sugammadex or neostigmine on renal function as determined with more specific and sensitive tests in laparoscopic cholecystectomy
- Conditions
- Sugammadex, Neostigmine
- Being tested
- Neostigmine, Sugammadex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeostigmineDrug
a combination of 0.04 mg/kg neostigmine with 0.01 mg/kg atropine intravenously at the reappearance of a second twitch of TOF after the last dose of rocuronium
SugammadexDrug
2-4 mg/kg sugammadex intravenously upon the reappearance of a post-tetanic count 1-2 or a second twitch of TOF after the last dose of rocuronium
| Study group | Role | What they receive |
|---|---|---|
| Neostigmine Group | Active comparator | Not described Receives: Drug: Neostigmine |
| Sugammadex Group | Active comparator | Not described Receives: Drug: Sugammadex |
What is being measured
The primary outcome is the main question the study is designed to answer.
neutrophil gelatinase associated lipocalin (NGAL) values
normal overall unisex value 47-55 ng/ml
Measured: baseline ( 2 days preoperative) and 12 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2023
- Study start1 Mar 2023
- Primary completion1 Sep 2023
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SugammadexStudies of the same condition, open and under way.
- More trials run by Menoufia UniversityThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Menoufia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, mostafa saieed fahim mansour, Menoufia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06081738
- Sponsor's protocol ID
- 2/2023ANSTH49
- Status last verified
- Oct 2023
- First submitted
- 23 Sep 2023
- Last updated
- 13 Oct 2023
- Results posted
- 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 13 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of The Effects of Neostigmine Versus Sugammadex on Renal Functions in Laparoscopic Cholecystecomy A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06081738
- Acronym / sponsor ID
- 2/2023ANSTH49
- Conditions
- Sugammadex, Neostigmine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Menoufia UniversityUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 13 Oct 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 study will assess the acute effects of sugammadex or neostigmine on renal function as determined with more specific and sensitive tests in laparoscopic cholecystectomy
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neostigmine Group | Active comparator | Drug: Neostigmine |
| Sugammadex Group | Active comparator | Drug: Sugammadex |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- normal renal function (serum Cr 0.4- 1.4 g/dL)
- American Society of Anesthesiologists (ASA) Class I-II
Key exclusion criteria (6 listed)
- Incapacity to consent.
- Pre-existing impaired kidney functions.
- Severe neuromuscular disease, as: myasthenia gravis \& muscular dystrophy.
- Intra-operative bleeding
- Lengthy operations that exceed 2 hours.
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 |
|---|---|---|
| Neostigminea combination of 0.04 mg/kg neostigmine with 0.01 mg/kg atropine intravenously at the reappearance of a second twitch of TOF after the last dose of rocuronium | Drug | Neostigmine Group |
| Sugammadex2-4 mg/kg sugammadex intravenously upon the reappearance of a post-tetanic count 1-2 or a second twitch of TOF after the last dose of rocuronium | Drug | Sugammadex Group |
Primary outcome
neutrophil gelatinase associated lipocalin (NGAL) values
Time frame: baseline ( 2 days preoperative) and 12 hours after surgery
normal overall unisex value 47-55 ng/ml
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 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 Phase 4 study testing Neostigmine and Sugammadex in people with Sugammadex and Neostigmine, run by Menoufia University at 1 site in Egypt.
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 2 inclusion and 6 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 13 Oct 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 Egypt. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
neutrophil gelatinase associated lipocalin (NGAL) values (time frame: baseline ( 2 days preoperative) and 12 hours after surgery). 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 13 Oct 2023.