Vitamin D Deficiency Clinical Trial
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.
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.
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.
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