Pregnancy Clinical Trial
Official title:
Comparison Between Dexmedetomidine and Remifentanil on the Maternal Responses to Tracheal Intubation in Severe Pre-eclamptic Patients During Caesarean Delivery
Preeclampsia is a pregnancy-specific, multisystem disorder that complicates approximately 5
% of pregnancies.
Tracheal intubation in the women with severe pre-eclampsia is usually associated with
exaggerated transient increases in blood pressure, heart rate and maternal plasma
catecholamine concentrations. These changes may lead to maternal cerebral oedema,
haemorrhage, left ventricular failure, pulmonary oedema or mortality, and reduce uterine
blood flow which may adversely affect the neonatal wellbeing. Therefore, the attenuation of
the haemodynamic responses to tracheal intubation in this unique group of patients is
demanding for the best of both mother and foetus.
The use of single remifentanil boluses of 0.5 to 1 µg/kg reduces effectively the
haemodynamic and catecholamine responses to laryngoscopy and tracheal intubation in severe
pre-eclamptics during Cesarean delivery under general anesthesia. Unfortunately, the use of
1 µg/kg doses are associated with more maternal hypotension and neonatal respiratory
depression requiring resuscitation. Moreover, the use of preinduction remifentanil bolus of
0.5 µg/kg followed by a continuous infusion at 0.15-0.2 µg/kg/min is associated with
significant attenuation of the maternal stress response to tracheal intubation with variable
degree of neonatal depression in non-pre-eclamptic women. Whereas, the use of infusion rates
of 0.1 µg/kg/min or less is less likely to produce neonatal depression.
In our previous study, we demonstrated that the preoperative administration of
dexmedetomidine 0.4 and 0.6 µg/kg/h, a specific alpha 2-adrenoceptor agonist, blunts the
maternal haemodynamic and hormonal responses to Caesarean delivery under sevoflurane
anaesthesia without adverse neonatal effects. However the use of 0.6 µg/kg/h doses is
associated with higher postoperative sedation scores.
We hypothesize that the preoperative intravenous dexmedetomidine (0.4 µg/kg/h) and
remifentanil (0.1 µg/kg/min) infusions will have comparable maternal haemodynamic responses
to tracheal intubation, surgical stimulation and extubation after uncomplicated Caesarean
delivery under general anesthesia in parturients with severe pre-eclampsia, without adverse
neonatal effects.
Anaesthetic management will be standardized in all studied patients. Oral ranitidine 150 mg
and metoclopramide 10 mg will be given the night before and on the morning of surgery, with
0.3 mol/L sodium citrate 30 mL given 15 min before induction. Magnesium sulphate will be
given as a loading dose of 4 g intravenously, followed by i.v. infusion of 1g/hour for
seizures prophylaxis.
Intravenous boluses of hydralazine 5 mg at 20-min intervals will be used if SAP increases
above 160 mm Hg or DAP above 110 mm Hg, to keep the diastolic blood pressure at
approximately 90 mmHg and the doses used will be recorded.
The studied population will be allocated randomly to one of two groups, (n = 18, in each),
by drawing sequentially numbered sealed opaque envelopes containing a software-generated
randomization code (Random Allocation Software, version 1.0.0, Isfahan University of Medical
Sciences, Isfahan, Iran), to receive either dexmedetomidine (0.4 µg/kg/h) or remifentanil
(0.1 µg/kg/min) starting 20 and 5 min before induction of anaesthesia, respectively, and
will be discontinued after peritoneal closure. The dexmedetomidine and remifentanil
solutions looked identical.
One anaesthesiologist who is not otherwise involved in the study, will prepare the study
solutions, install them in the infusion pumps, set up the dose according to the assigned
randomized dose, and will mask the infusion pumps with an opaque sheet throughout the
procedure to ensure the blindness of the assessors. Another anaesthesiologist who will be
blinded to treatment regimen provided perioperative care. A third anaesthesiologist will
collect perioperative data. All staff in the operating room will be unaware of patient
allocation.
Maternal monitoring will include three lead-electrocardiography, non-invasive blood
pressure, and pulse oximetry. Left uterine displacement will be maintained.
After preoxygenation for 3 min, rapid sequence induction will be performed using propofol
1.5-2.5 mg/kg and suxamethonium 1 mg/kg with the application of cricoid pressure from the
time of loss of the consciousness until the inflation of the cuff of the endotracheal tube.
Laryngoscopy will be performed after the 1-min blood pressure recording, and tracheal
intubation will be completed before the 2-min reading. Correct placement of the endotracheal
tube will be confirmed with direct visualization of the passage of its tip between the vocal
cords, auscultation of equal breath sounds on both sides of the chest and capnography
waveform. The patient's lungs will be mechanically ventilated to maintain (ETCO2) at
30-35mmHg. Anaesthesia will be maintained with a 0.5-0.7% minimum alveolar concentration of
sevoflurane in oxygen. Atracurium 0.5 mg/kg will be given for muscle relaxation to maintain
suppression of the second twitch using a train-of-four stimulation. The
Induction-to-delivery time will be recorded using a stopwatch.
After the umbilical cord is clamped, a 5-10 IU infusion of oxytocin in 500 mL of lactated
Ringer's solution will be started and morphine 0.1 mg/kg will be given. After peritoneal
closure, study solution will be discontinued.At the end of surgery, sevoflurane will be
discontinued, residual neuromuscular block will be antagonized and the trachea will be
extubated.
Postoperative analgesia will be achieved according to the authors' hospital protocol with
12-hourly IM diclofenac (75 mg), 6-hourly IVI paracetamol (1 g), and rescue doses of IV
meperidine (25 mg).
Statistical analysis:
Data will be tested for normality using the Kolmogorov-Smirnov test. X2 test will be used
for categorical data. Repeated-measures analysis of variance will be done to test the serial
changes in hemodynamic and cortisol data. Student-t- and Mann Whitney U tests will be used
to compare the parametric and nonparametric data between the two studied groups. Data will
be expressed as mean (SD), number (%), or median [range]. p < 0.05 will be considered to
represent statistical significance.
In a previous study, Yoo et al have demonstrated that the mean (SD) values of MAP at 1 min
after tracheal intubation in those received remifentanil bolus were 118 (20) mm Hg. A priori
power analysis revealed that 16 patients would be needed in each group to detect a 20%
difference in MAP values, 1 min after intubation, after the administration of remifentanil
with a type I error of 0.05 and a power of 90%. We assumed that the detection of 20%
differences in the mean MAP would be of clinically importance. We increased the sample size
by 10% to compensate for patients dropping out during the study.
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