Neuromuscular BlockadePhase 4NCT05313100
Sugammadex and Smoker's Neuromuscular Block
A Phase 4 study testing sugammadex in people with Neuromuscular Blockade and Smoking, run by Duzce University.
Trial summary
We compared the durations of antagonizing and of the severity of effect of sugammadex used in antagonizing the rocuronium in smoker and non-smoker total 40 patients with using Train of Four(TOF) neuromuscular monitorization. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Neuromuscular Blockade, Smoking
- What is being tested?
- sugammadex
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Apr 2012to Aug 2013
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Elective surgery,
- 1-2 according to the ASA ( American Society of Anesthesiologist ) physical status classification.
- Patients who have smoked at least 10 packs or have been smoking for 10 years and currently smoking
- Or never smoked patients
Who cannot join
- neuromuscular diseases
- radiotherapy and/or chemotherapy anamnesis,
- liver and/or renal disease,
- electrolyte balance,
- history of drug use which affects neuromuscular transmission,
- Body Mass Index (BMI) of more than 27,
- use alcohol
About this study
Official title: The Evaluation of the Effects of the Use of Rocuronium and Sugammadex on Neuromuscular Block in Smoker
We compared the durations of antagonizing and of the severity of effect of sugammadex used in antagonizing the rocuronium in smoker and non-smoker total 40 patients with using Train of Four(TOF) neuromuscular monitorization.
Read the detailed description
40 patients from American Society of Anesthesiologist (ASA) I- II class, being smokers for at least 10 years or non-smokers, who will undergo elective surgery were included in this randomized prospective study. Patients underwent routine monitoring and neuromuscular monitoring. Propofol 2 mg/kg and intravenous fentanyl 1 mcg/kg were applied at induction. After the loss of eyelash reflex, intravenous rocuronium 0,6 mg/kg was administered. The patient was intubated at a Train of Four count of 2. Anesthesia was continued with 50% O2 + 50% air and sevoflurane 2 % . Rocuronium 0,15 mg/kg was administered when TOF (Train of Four) counter reached 2 during the operation. Sugammadex 2 mg/kg was administered at the end of the operation. The time to reach Train of Four values of 0,7-0,8-0,9 were recorded.
- Conditions
- Neuromuscular Blockade, Smoking
- Being tested
- sugammadex
- Keywords
- sugammadex, smoking, neuromuscular blockade
- Medical subject headings
- Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sugammadexDrug
Also called bridion
At the end of the operation, at least 15 minutes after the last dose of rocuronium, sugammadex 2 mg / kg was administered both of groups
| Study group | Role | What they receive |
|---|---|---|
| Smokers | Active comparator | The patients who have smoked at least 10 packs or have been smoking for 10 years and currently smoking were included in the smoker group At the end of operation for reversal of neuromuscular blockade sugammadex used. Receives: Drug: sugammadex |
| Nonsmokers | Sham comparator | The patients who never smoked were included in the non-smoker group At the end of operation for reversal of neuromuscular blockade sugammadex used. Receives: Drug: sugammadex |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neuromuscular block recovery time
Time to reach TOF %90 measurement after given neuromuscular blocker reverse agent
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2022
- Study startApr 2012
- Primary completionJan 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuromuscular BlockadeStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duzce University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gulbin Sezen, Study director, Duzce University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05313100
- Sponsor's protocol ID
- 2012.04.HD.067
- Status last verified
- Apr 2022
- First submitted
- 6 Aug 2015
- Last updated
- 18 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Evaluation of the Effects of the Use of Rocuronium and Sugammadex on Neuromuscular Block in Smoker
- ClinicalTrials.gov ID
- NCT05313100
- Acronym / sponsor ID
- 2012.04.HD.067
- Conditions
- Neuromuscular Blockade, Smoking
- Keywords
- sugammadex, smoking, neuromuscular blockade
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Duzce UniversityUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Jan 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 6 Apr 2022 (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.
We compared the durations of antagonizing and of the severity of effect of sugammadex used in antagonizing the rocuronium in smoker and non-smoker total 40 patients with using Train of Four(TOF) neuromuscular monitorization.
Detailed description
40 patients from American Society of Anesthesiologist (ASA) I- II class, being smokers for at least 10 years or non-smokers, who will undergo elective surgery were included in this randomized prospective study. Patients underwent routine monitoring and neuromuscular monitoring. Propofol 2 mg/kg and intravenous fentanyl 1 mcg/kg were applied at induction. After the loss of eyelash reflex, intravenous rocuronium 0,6 mg/kg was administered. The patient was intubated at a Train of Four count of 2. Anesthesia was continued with 50% O2 + 50% air and sevoflurane 2 % . Rocuronium 0,15 mg/kg was administered when TOF (Train of Four) counter reached 2 during the operation. Sugammadex 2 mg/kg was administered at the end of the operation. The time to reach Train of Four values of 0,7-0,8-0,9 were recorded.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Smokers | Active comparator | Drug: sugammadexThe patients who have smoked at least 10 packs or have been smoking for 10 years and currently smoking were included in the smoker group At the end of operation for reversal of neuromuscular blockade sugammadex used. |
| Nonsmokers | Sham comparator | Drug: sugammadexThe patients who never smoked were included in the non-smoker group At the end of operation for reversal of neuromuscular blockade sugammadex used. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Elective surgery,
- 1-2 according to the ASA ( American Society of Anesthesiologist ) physical status classification.
- Patients who have smoked at least 10 packs or have been smoking for 10 years and currently smoking
- Or never smoked patients
Key exclusion criteria (7 listed)
- neuromuscular diseases
- radiotherapy and/or chemotherapy anamnesis,
- liver and/or renal disease,
- electrolyte balance,
- history of drug use which affects neuromuscular transmission,
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 |
|---|---|---|
| sugammadexAlso: bridionAt the end of the operation, at least 15 minutes after the last dose of rocuronium, sugammadex 2 mg / kg was administered both of groups | Drug | Nonsmokers, Smokers |
Primary outcome
Neuromuscular block recovery time
Time frame: six months
Time to reach TOF %90 measurement after given neuromuscular blocker reverse agent
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 18 Apr 2022.
- 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.
Gulbin Sezen study director
Duzce University
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing sugammadex in people with Neuromuscular Blockade and Smoking, run by Duzce University.
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 7 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 18 Apr 2022. 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.
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?
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?
Neuromuscular block recovery time (time frame: six months). 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 18 Apr 2022.