Vitamin D DeficiencyNCT03734250
D Vitamin Effects on Neuromuscular Blocker Reverse Time
An observational study of Vitamin D Deficiency and Neuromuscular Block, run by Duzce University.
Trial summary
Background/aim: Investigators aimed to investigate the effect of D vitamin levels on Sugammadex and Neostigmine reverse durations in the study. Materials and methods: Eighty patients between 18 and 65 years, with ASA I-III status who were undergoing surgery under general anaesthesia were included the study. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Vitamin D Deficiency, Neuromuscular Block, Neuromuscular Block Problem
- How many people
- 84 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2014to 1 Mar 2018
- How long will I take part?
- 1 Day
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Eighty four patients with ASA I-III status undergoing surgery under general anesthesia between the ages of 18 and 65 years were included the study
Who may be able to join
- undergoing surgery under general anesthesia
- ASA I-III
- between the ages of 18 and 65 years old.
Who cannot join
- diabetes
- kidney
- muscle
- hepatic diseases
- metabolic diseases
About this study
Official title: The Effect of D Vitamin Status on Different Neuromuscular Blocker Agents Reverse Time
Background/aim: Investigators aimed to investigate the effect of D vitamin levels on Sugammadex and Neostigmine reverse durations in the study.
Materials and methods: Eighty patients between 18 and 65 years, with ASA I-III status who were undergoing surgery under general anaesthesia were included the study. All patients were randomly divided into two groups with double blindness and 1.25 (OH) 2 vitamin D, 25 (OH) 2 vitamin D, and calcium levels were measured. At the end of the operation, 2 mg/kg of Sugammadex was administered to one group and Atropine + Neostigmine to the other group. The patients were also divided into two groups as to whether their vitamin D levels were ≥ 30 ng/mL or below.
Read more
A train of four values was recorded after a hypnotic agent was given at the beginning and throughout the operation. The time to complete the disappearance of response to TOF stimulation was recorded as T0.
End of the operation: When 2 responses to TOF stimulation were taken, the following times were recorded until the extubation phase by administering at least 2 mg/kg of Sugammadex or 0.05 mg/kg of Neostigmine 0.05 mg/kg of Atropine per kg of body weight. The time until the TOF value reached 50,70,90% and extubation were recorded.
Read the detailed description
Prospective observational study was carried out in the same centre after the approval of the University Hospital by the ethical committee of non-invasive research (Duzce University, School of Medicine, Ethics Committee of Non-invasive clinical research approval for application Date: 11.10.2013, Decision Number: 2013/439) and done by Anaesthesiology Department in the same centre. This research was also funded by our University Scientific Research Project Coordinating Department (2014.04.02.221).
Eighty-four patients with ASA I-III status, undergoing surgery under general anaesthesia between the ages of 18 and 65 years were included the study. Twenty millilitre blood samples were taken from the antecubital ven before the operation, after taken the approval of all patients. 1.25 (OH) 2 vitamin D, 25 (OH) 2 vitamin D, calcium, magnesium, phosphorus and parathormone levels were measured in the blood samples. All patients were randomly divided into two groups with double blindness. At the end of the operation, a 2 mg/kg dose of Sugammadex (Group Sugammadex n = 40) and 0.55 mg/kg + 0.015 mg/kg atropine Neostigmine (to the other group) were administered intravenously. The patients were also divided into two groups, having vitamin D levels above 30 ng/mL and below 30 ng/mL.
All patients were connected to a kinemyograph, which placed the neuromuscular transmission (NMT) module (GE Health Care) on the patients' adductor pollicis muscle before the anaesthesia induction. Patients body temperature were monitored and maintained within 35-37 0 C. Subsequently, the hypnotic agent was given at the beginning of the operation and Train of Four (TOF) values were recorded as % values throughout the operation. All patients received 2 mg of Midazolam intravenously for premedication. All patients were monitored by standard monitoring and received 2 mg / kg Propofol and 1 mcg/kg Fentanyl. Train of Four (TOF) stimulation started at 1 Hz intervals at a frequency of 2 Hz in 1-minute intervals. The initial values determined were recorded as the baseline TOF values and 0.5 mg / kg Rocuronium (Esmeron amp, Organon, Holland) was administered intravenously, which was calculated on ideal body weight. The time to complete disappearance of response to TOF stimulation was recorded as T0 and endotracheal intubation was performed.
Anaesthetic maintenance was proven by 50% oxygen + 50% air + 2% volume Sevoflurane via endotracheal tube. Remifentanil was administered intravenously at 0.05-1 mcgr /kg /h. When a 2-point response to TOF was received, the muscle relaxant was administered in repeated doses as 10 mg of Rocuronium.
The total muscle relaxant quantities were recorded. At the end of the operation: when 2 responses to TOF stimulation were taken, the following times were recorded until the extubation phase by administering at least 2 mg/kg of Sugammadex (Bridion flk, Merck Sharp \& Dohme) or 0.05 mg/kg of Neostigmine (Neostigmin amp, Adeka, Turkey) and 0.05 mg/kg of Atropine per kg body weight.
T0.5: The time until the TOF value reached 50% T0.7: The time until the TOF value reached 70% T0.9: The time until the TOF value reached 90% Teks: Time to extubation.
Patients, who were able to open their eyes with spontaneous breathing, had a tidal volume of 10 ml/kg, according to ideal body weight during spontaneous breathing, pulse oximetry values above 95%, headache for 5 seconds, and TOF values above 90%.
Statistical analysis
Investigators used the independent samples t-test for two variables, continuous variables for comparison, and the Pearson Chi-square test for categorical variables. Repeated measures ANOVA was used to examine the interaction between drug groups and TOF measurement time. Co-effects of drug groups and vitamin D subgroups were examined by two-way analysis of variance (ANOVA). Repeated measures ANOVA, one of the three-factor differentials, were used to examine the TOF measurement time interaction of drug effects and vitamin D subgroups' concerted effects. Statistical analyses were performed with the SPSS v.22 packet program and the significance level was taken as 0.05.
- Keywords
- Sugammadex, Neostigmine, Anesthesia, Neuromuscular blockers, Reverse time, Vitamin D
- Medical subject headings
- Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group Sugammadex HD | Sugammadex used as neuromuscular blocker reverse agent with Vitamin D status equal or above 30ng/ml | |
| Group neostigmine HD | Neostigmine used as neuromuscular blocker reverse agent with Vitamin D status equal or above 30 ng/ml | |
| Group Sugammadex LD | Sugammadex used as neuromuscular reverse agent with Vitamin D status under 30 ng/ml | |
| Group Neostigmine LD | Neostigmine used as neuromuscular reverse agent with Vitamin D status under 30ng/ml |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reverse times
The time until the TOF value reaches 50,70,90% and extubation were recorded.
Measured: 10 minute
Secondary outcomes (1)
Rocuronium effect unset time
Time to complete disappearance of response to TOF stimulation was recorded as T0
Measured: 4 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2018
- Study start1 Nov 2014
- Primary completion1 Mar 2018
- Study completion1 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vitamin D DeficiencyStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 84 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Duzce University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- İlknur S Yorulmaz, Dr, Principal investigator, Duzce University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03734250
- Sponsor's protocol ID
- 2014.04.02.221
- Status last verified
- Nov 2018
- First submitted
- 6 Oct 2018
- Last updated
- 7 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Holick MF. Vitamin D status: measurement, interpretation, and clinical application. Ann Epidemiol. 2009 Feb;19(2):73-8. doi: 10.1016/j.annepidem.2007.12.001. Epub 2008 Mar 10.
PubMed 18329892
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of D Vitamin Status on Different Neuromuscular Blocker Agents Reverse Time
- ClinicalTrials.gov ID
- NCT03734250
- Acronym / sponsor ID
- 2014.04.02.221
- Keywords
- Sugammadex, Neostigmine, Anesthesia, Neuromuscular blockers, Reverse time, Vitamin D
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Duzce UniversityUniversity, hospital or other
- Study start
- 1 Nov 2014 (actual)
- Primary completion
- 1 Mar 2018 (actual)
- Study completion
- 1 Mar 2018 (actual)
- First posted
- 7 Nov 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.
Background/aim: Investigators aimed to investigate the effect of D vitamin levels on Sugammadex and Neostigmine reverse durations in the study.
Materials and methods: Eighty patients between 18 and 65 years, with ASA I-III status who were undergoing surgery under general anaesthesia were included the study. All patients were randomly divided into two groups with double blindness and 1.25 (OH) 2 vitamin D, 25 (OH) 2 vitamin D, and calcium levels were measured. At the end of the operation, 2 mg/kg of Sugammadex was administered to one group and Atropine + Neostigmine to the other group. The patients were also divided into two groups as to whether their vitamin D levels were ≥ 30 ng/mL or below.
A train of four values was recorded after a hypnotic agent was given at the beginning and throughout the operation. The time to complete the disappearance of response to TOF stimulation was recorded as T0.
End of the operation: When 2 responses to TOF stimulation were taken, the following times were recorded until the extubation phase by administering at least 2 mg/kg of Sugammadex or 0.05 mg/kg of Neostigmine 0.05 mg/kg of Atropine per kg of body weight. The time until the TOF value reached 50,70,90% and extubation were recorded.
Detailed description
Prospective observational study was carried out in the same centre after the approval of the University Hospital by the ethical committee of non-invasive research (Duzce University, School of Medicine, Ethics Committee of Non-invasive clinical research approval for application Date: 11.10.2013, Decision Number: 2013/439) and done by Anaesthesiology Department in the same centre. This research was also funded by our University Scientific Research Project Coordinating Department (2014.04.02.221).
Eighty-four patients with ASA I-III status, undergoing surgery under general anaesthesia between the ages of 18 and 65 years were included the study. Twenty millilitre blood samples were taken from the antecubital ven before the operation, after taken the approval of all patients. 1.25 (OH) 2 vitamin D, 25 (OH) 2 vitamin D, calcium, magnesium, phosphorus and parathormone levels were measured in the blood samples. All patients were randomly divided into two groups with double blindness. At the end of the operation, a 2 mg/kg dose of Sugammadex (Group Sugammadex n = 40) and 0.55 mg/kg + 0.015 mg/kg atropine Neostigmine (to the other group) were administered intravenously. The patients were also divided into two groups, having vitamin D levels above 30 ng/mL and below 30 ng/mL.
All patients were connected to a kinemyograph, which placed the neuromuscular transmission (NMT) module (GE Health Care) on the patients' adductor pollicis muscle before the anaesthesia induction. Patients body temperature were monitored and maintained within 35-37 0 C. Subsequently, the hypnotic agent was given at the beginning of the operation and Train of Four (TOF) values were recorded as % values throughout the operation. All patients received 2 mg of Midazolam intravenously for premedication. All patients were monitored by standard monitoring and received 2 mg / kg Propofol and 1 mcg/kg Fentanyl. Train of Four (TOF) stimulation started at 1 Hz intervals at a frequency of 2 Hz in 1-minute intervals. The initial values determined were recorded as the baseline TOF values and 0.5 mg / kg Rocuronium (Esmeron amp, Organon, Holland) was administered intravenously, which was calculated on ideal body weight. The time to complete disappearance of response to TOF stimulation was recorded as T0 and endotracheal intubation was performed.
Anaesthetic maintenance was proven by 50% oxygen + 50% air + 2% volume Sevoflurane via endotracheal tube. Remifentanil was administered intravenously at 0.05-1 mcgr /kg /h. When a 2-point response to TOF was received, the muscle relaxant was administered in repeated doses as 10 mg of Rocuronium.
The total muscle relaxant quantities were recorded. At the end of the operation: when 2 responses to TOF stimulation were taken, the following times were recorded until the extubation phase by administering at least 2 mg/kg of Sugammadex (Bridion flk, Merck Sharp \& Dohme) or 0.05 mg/kg of Neostigmine (Neostigmin amp, Adeka, Turkey) and 0.05 mg/kg of Atropine per kg body weight.
T0.5: The time until the TOF value reached 50% T0.7: The time until the TOF value reached 70% T0.9: The time until the TOF value reached 90% Teks: Time to extubation.
Patients, who were able to open their eyes with spontaneous breathing, had a tidal volume of 10 ml/kg, according to ideal body weight during spontaneous breathing, pulse oximetry values above 95%, headache for 5 seconds, and TOF values above 90%.
Statistical analysis
Investigators used the independent samples t-test for two variables, continuous variables for comparison, and the Pearson Chi-square test for categorical variables. Repeated measures ANOVA was used to examine the interaction between drug groups and TOF measurement time. Co-effects of drug groups and vitamin D subgroups were examined by two-way analysis of variance (ANOVA). Repeated measures ANOVA, one of the three-factor differentials, were used to examine the TOF measurement time interaction of drug effects and vitamin D subgroups' concerted effects. Statistical analyses were performed with the SPSS v.22 packet program and the significance level was taken as 0.05.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group Sugammadex HD | – | –Sugammadex used as neuromuscular blocker reverse agent with Vitamin D status equal or above 30ng/ml |
| Group neostigmine HD | – | –Neostigmine used as neuromuscular blocker reverse agent with Vitamin D status equal or above 30 ng/ml |
| Group Sugammadex LD | – | –Sugammadex used as neuromuscular reverse agent with Vitamin D status under 30 ng/ml |
| Group Neostigmine LD | – | –Neostigmine used as neuromuscular reverse agent with Vitamin D status under 30ng/ml |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Eighty four patients with ASA I-III status undergoing surgery under general anesthesia between the ages of 18 and 65 years were included the study
Key inclusion criteria (3 listed)
- undergoing surgery under general anesthesia
- ASA I-III
- between the ages of 18 and 65 years old.
Key exclusion criteria (5 listed)
- diabetes
- kidney
- muscle
- hepatic diseases
- metabolic diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Reverse times
Time frame: 10 minute
The time until the TOF value reaches 50,70,90% and extubation were recorded.
1 secondary outcome
Rocuronium effect unset time
Time frame: 4 minute
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 7 Nov 2018.
- Background: PubMed 18329892Holick MF. Vitamin D status: measurement, interpretation, and clinical application. Ann Epidemiol. 2009 Feb;19(2):73-8. doi: 10.1016/j.annepidem.2007.12.001. Epub 2008 Mar 10.
- PubmedLink provided by the sponsor.
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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.
İlknur S Yorulmaz, Dr principal investigator
Duzce University
Questions about this trial
What is this clinical trial studying?
An observational study of Vitamin D Deficiency and Neuromuscular Block, 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 3 inclusion and 5 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 7 Nov 2018. 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. 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?
Reverse times (time frame: 10 minute). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03734250, which also lists 1 linked publication.
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 7 Nov 2018.