Clinical trial NCT00482573: Dental Anesthesia in Pregnant Women With Rheumatic Heart Disease
Official title: Maternal-Fetal Monitoring of Patients With Rheumatic Heart Disease During Dental Procedure Under Local Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Rheumatic Heart Disease
Pregnancy
Dental Caries
Keywords: Electrocardiography, ambulatory/methods
Blood Pressure monitoring, ambulatory/methods
Cardiotocography/methods
Dental restoration, permanent
Anesthesia, local /methods
Lidocaine
Vasoconstrictor Agents
Epinephrine
Pregnancy
Rheumatic Heart Disease
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2007-06-05
Enrollment: 31
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The hemodynamic parameters of 31 pregnant women with rheumatic valve disease, undergoing restorative dentistry under local anesthesia with 2% solution of lidocaine, divided in two groups, with (Group LE) and without 1:100,000 epinephrine solution (Group LNE), were studied by 24-hour ambulatory electrocardiographic monitoring, intermittent blood pressure monitoring and continuous cardiotocography, during three standard time periods. A significant decrease in the values of maternal heart rate was seen during the procedure, in comparison with the other two time periods in the two groups, as well as, the occurrence of cardiac arrhythmia in 9 (29.1%) patients, being 7 (41.8%) of them in the group receiving epinephrine anesthesia. We conclude the use of 2% lidocaine in association with epinephrine proved safe during dental procedure in pregnant women with rheumatic valve disease.

Detailed description: During pregnancy, the organic systems of a woman are subjected to physiological modifications consequential to hormonal, anatomic and metabolical alterations. The most significant modification in the circulatory system is an increased cardiac output from the first three months of gestation. Women with heart disease may present with severe complications during the gestational period, because of inappropriate adaptation of her body to this hemodynamic overload, even those patients who are thought to have an appropriate functional capacity during early pregnancy. There are scant studies in the literature on the effects of local anesthetics, with and without vasoconstrictor, used in dental procedures on the cardiovascular variables of pregnant women with valvar disease, as well as on their concepti. Driven by this shortage, we decided to have this subject studied, by assessing and analyzing cardiotocographic parameters, such as fetal heart rate (FHR), fetal motility(FM) and uterine contractions (UC), in addition to blood pressure (BP) and electrocardiographic variables, such as heart rate (HR) and extrasystoles (ES), in pregnant women with rheumatic valvar disease who undergo local anesthesia with lidocaine, with and without vasoconstrictor, during restorative dental procedure. For this, 31 rheumatic heart disease patients who were in their 28th to 37th week of gestation, had 24-hour ambulatory monitoring of their BP and Holter electrocardiography (Holter-ECG), and cardiotocography (CTG), performed during: (1) baseline - 60 minutes before the procedure for BP and Holter-ECG monitoring, and 20 minutes before the procedure for CTG; (2) procedure - 56±15.5 minutes (mean±SD); (3) post-procedure - 20 minutes; and (4) mean 24-hour HR and ES measurement, and mean wake and sleeping periods BP monitoring. Variation of the above variables was analyzed in two groups, one with infusion of a 2% solution of lidocaine without vasoconstrictor (Group LNE) composed of 14 patients, and the other with infusion of a 2% solution of lidocaine with epinephrine 1:100,000 (Group LE) composed of 17 patients, randomized drawing and single blind. The investigator wise person which solution of lidocaine was being used, therefore the proper local vasoconstriction denounced if it was infiltrated or not epinephrine. The used technique was of the modified periodontal ligament (PDLm injection), by means of the equipment The Wand, infusing 1.8 ml (one cartridge) in six minutes. We use the technique of analysis of variance (ANOVA) with repeated measures to calculate the size of the sample and for the analysis and multiple interpretation of the variable in three distinct periods, on the basis of the table of Vonesh and Shork (15 patients in each group, considering a correlation enters the measures of next value the 0,4, a level of significance of 5% and to be able of test of 80%). All the variable had been initially analyzed descriptive. For the quantitative variable this analysis was made through the comment of the minimum and maximum values, and of the calculation of medium averages and shunting line-standard and. For the qualitative variable we calculate absolute and relative frequencies. The level of significance used for the tests was of 5% (p\<0,05).The maternal HR values obtained during the procedure showed a significant reduction only in comparison with the other time periods (P\<0.001)in the two groups. The comparison of the groups LE e LNE did not reveal any significant difference (P\>0.05). ES was detected in 9 (29.0%) patients, being 7 of them (41.8%) from the Group LE. BP did not show any significant difference neither between time periods, nor between groups (P\>0.05). The same occurred in the comparative analysis of the fetal parameters obtained during CTG - number of UC, level and variability from baseline of the FHR, number of accelerations of the FHR and fetal reactivity pattern. Our conclusion was that the use of 2% solution of lidocaine in association with epinephrine proved safe during dental procedure in pregnant women with rheumatic valvar cardiopathy.

Eligibility criteria: Inclusion Criteria:

* Clinical criteria: women with rheumatic valvar disease as diagnosed by the clinical history and physical examination, and documented by Doppler echocardiography, either having undergone surgical or percutaneous intervention before becoming pregnant or not, in functional class (FC) I or II, according to classification of the New York Heart Association (NYHA).
* Obstetrical criteria: one fetus pregnancy, gestational age (GA) between 28 and 37 weeks.
* Odontological criteria: total or partial dentition, with the presence of lower premolar and/or molar teeth in need of restorative dentistry due to development of dental caries (Black Class I, II and/or V), or due to the presence of restorations with edge infiltration clinically and/or radiographically diagnosed recurrent caries.

Exclusion Criteria:

* Clinical criteria: heart failure, uncontrolled chronic arterial hypertension, or complex and/or symptomatic ventricular arrhythmia.
* Obstetrical criteria: preeclampsia, uterine growth restriction, and labor.
* Odontological criteria: dental caries in lower premolar or molar tooth with clinical and/or radiographic diagnosis of pulpal exposure, pulpitis, or pulpal necrosis, fracture or destruction of the tooth crown with prognostic of endodontic treatment or rehabilitation by prosthesis, or indication for extraction.
* Psychiatric criteria: patients with anxiety disorders such as panic, agoraphobia, social or specific phobias and obsessive-compulsive disorders, posttraumatic stress, or chemically-induced anxiety, according to the classification of the American Psychiatric Association (APA).

Primary outcomes:
measure: Maternal: Blood Pressure, Heart Rate and Extrasystoles; Maternal-Fetal: Fetal Heart Rate, number of uterine contractions, motility and fetal reactivity pattern, in function of presence or not of epinephrine 1:100000 in the 2% solution.of lidocaine
timeFrame: 4 periods Maternal: (1) Baseline - 60 minutes before the procedure, (2) Procedure, (3) Post-Procedure - 20 minutes, and (4) mean 24-hour; 3 periods Maternal-Fetal: (1) Baseline: 20 minutes before, (2) Procedure, and (3) Post-Procedure - idem maternal
Secondary outcomes:
measure: They had been the same analyses used for the Primary Outcome Measures, in function of the gestational age (GA): sub-group GA1 (15 pregnant women between 28 and 31 weeks) and sub-group GA2 (16 pregnant women between 28 and 31 weeks).
timeFrame: They had been the same periods established for the Time Frame of Primary Outcome Measure
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Heart Institute (InCor) of University of São Paulo Medical School
Study officials:
affiliation: Heart Institute (InCor) of University of São Paulo Medical School - Sao Paulo, Brazil
name: Itamara LI Neves, PhD
role: PRINCIPAL_INVESTIGATOR
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