Use of Remifentanil Associated with Lidocaine for Feticides in Late Terminations of Pregnancy: A Randomized Clinical Trial

2021 ◽  
pp. 1-7
Author(s):  
Romy Rayssiguier ◽  
Florent Fuchs ◽  
Eve Mousty ◽  
Estelle Morau ◽  
Tarik Hlioua ◽  
...  

<b><i>Introduction:</i></b> In France, performance of a termination of pregnancy is legally possible without any gestational age limit. After 22 weeks of gestation, a feticide is ethically performed using usually sufentanil and lidocaine. The aim of this study was to compare the use of remifentanil, a fast-acting morphine-derivating product, instead of sufentanil. <b><i>Methods:</i></b> This 2-center randomized, controlled, single-blinded phase-III treatment trial had 2 parallel arms: an experimental group using remifentanil with lidocaine versus a control group receiving sufentanil associated with lidocaine. This trial took place over a 40-month period. The primary outcome was time to fetal asystole after lidocaine injection. The secondary outcome measures were the procedure’s success rate, the rate of serious maternal side effects, and the presence of cellular or tissue modifications. <b><i>Results:</i></b> The study included 66 women, randomized into 2 groups of similar size and characteristics. Time to fetal asystole did not differ significantly between the groups, with a delay of 4 min (Q1−Q3, 2–11) in the sufentanil group and 4 min (Q1−Q3, 1–10) in the remifentanil group (<i>p</i> = 0.84). Similarly, the success rate of the procedure did not differ significantly. Fetal asystole was procured in &#x3c;2 min and persisted &#x3e;1 min for 16 (25.8%) women in our total population: 7 (22.5%) in the sufentanil group and 9 (29.0%) in the remifentanil group, <i>p</i> = 0.77. No severe maternal side effects were observed. Among the 49 fetopathological examinations performed, the few tissue and cell modifications observed did not cause any interpretation difficulties in either group. <b><i>Discussion/Conclusion:</i></b> Use of remifentanil instead of sufentanil for feticide procedure did not improve time to fetal asystole. No harmful effect was observed for either maternal tolerance or interpretation of the histologic slides.

2015 ◽  
Vol 1 (1) ◽  
pp. 16-19
Author(s):  
Sarada Duwal Shrestha ◽  
Alka Singh ◽  
Laxmi RC ◽  
Benita Pradhan ◽  
Wufei Shah ◽  
...  

Introductions: The termination of second trimester pregnancy is challenging due unfavorable cervix. This study evaluate the efficacy and maternal side effects of intravaginal misoprostol for termination of second trimester pregnancy. Methods: During one year period from 15th June 2011 to 14th June 2012, Department of Obstetrics and Gynaecology of Patan Hospital, women admitted for second trimester termination of pregnancy for fetal congenital anomalies and intrauterine fetal demise were studied using the International Federation of Gynaecology and Obstetrics recommended doses of vaginal misoprostol. For congenital anomalies, 400 mcg 3 hourly to a maximum of 5 doses were used. For fetal demise, gestational age of 13-17 weeks received 200 mcg every 6 hourly to a maximum of 4 doses, and 18-26 weeks dose was adjusted to 100 mcg. Main outcome measures included success rate of abortion within 48 hours, induction to delivery interval and maternal side effects. Results: There were 40 patients during study period. Success rate for termination of 2nd trimester pregnancy within 48 hours was 88.8% for congenital anomalies. For fetal demise, success of termination was 90.9% at 13-17 weeks and 100% at 18-26 weeks. Median time from induction to delivery was 26.8 hours for congenital anomalies. For fetal demise, it was 18 hours for 13-17 weeks was and 24 hours at 18 to 26 weeks respectively. Abdominal pain was seen in all doses of misoprostol. Conclusions: Vaginal misoprostol is an effective method for termination of second trimester pregnancy. Plain Language Summary: The study was conducted to see the effectiveness of vaginal misoprostol for termination of second trimester pregnancy. The success rate of termination for congenital abnormality and fetal demise was high. Vaginal misoprostol was an effective method for termination of second trimester pregnancy. DOI: http://dx.doi.org/10.3126/jpahs.v1i1.13010 Journal of Patan Academy of Health Sciences. 2014 Jun;1(1):16-19


PEDIATRICS ◽  
1993 ◽  
Vol 91 (2) ◽  
pp. 379-382 ◽  
Author(s):  
Joaquim M.B. Pinheiro ◽  
Sue Furdon ◽  
Luis F. Ochoa

Local anesthesia decreases physiologic responses to pain in neonates but has not been used routinely during lumbar punctures in newborns, as it might obscure anatomical landmarks. However, local anesthesia may decrease newborns' struggling during lumbar puncture, thus facilitating the procedure and increasing its success rate. The success rate of lumbar punctures was compared in neonates allocated prospectively to 0.2 to 0.5 mL of 1% lidocaine anesthesia (n = 48) or a control group (n = 52). Newborns were held in a modified lateral recumbent postion (neck not flexed) and their struggling response to the various steps in the lumbar puncture was scored by the holder. The newborns' struggling motion score increased in response to lidocaine injection, but response to the subsequent spinal needle insertion was significantly decreased. Despite this decreased motion, no differences were noted in the number of attempts per lumbar puncture (1.9 ± 0.2 [SEM] in lidocaine and 2.1 ± 0.2 in control groups), rate of lumbar puncture failure (15% in lidocaine and 19% in control groups), or the number of traumatic lumbar punctures (46% in both groups). The success rate of lumbar puncture was not dependent on level of training of physicians performing the procedure. No acute complications, cerebrospinal fluid contamination, or subsequent meningitis was noted in either group. It is concluded that local anesthesia with lidocaine decreases the degree of struggling but does not alter the success rate of lumbar puncture in neonates. The practice of withholding lidocaine anesthesia from neonates undergoing lumbar punctures cannot be justified by arguing that it makes the procedure more difficult to perform.


2018 ◽  
Vol 36 (34_suppl) ◽  
pp. 219-219
Author(s):  
Myo Zaw ◽  
Anita Sultan ◽  
Sriman Swarup ◽  
Myat M. Han ◽  
Yin Mon Myat ◽  
...  

219 Background: Inhibition of poly adenosine diphosphate ribose polymerase (PARP) enzymes terminates an alternative DNA repair pathway, resulting in synthetic lethality in homologous recombination deficient tumors. Many PARP inhibitors have shown to improve survival in many solid tumors with noteworthy safety concerns. We undertook a systematic review and meta-analysis of randomized controlled trials (RCT) to determine the risk of gastrointestinal (GI) and hepatic toxicities. Methods: We conducted a comprehensive literature search using MEDLINE, EMBASE databases and meeting abstracts from inception through June 2018. Phase III RCTs that mention GI toxicities and elevation of aspartate aminotransferase (AST) or alanine aminotransferase (ALT) as adverse effects were incorporated in the analysis. Mantel-Haenszel (MH) method was used to calculate the estimated pooled risk ratio (RR) with 95% confidence interval (CI). Random effects model was applied. Results: 3188 patients from 7 phase III RCTs with breast, ovarian and gastric cancer were eligible. Studies compared olaparib or niraparib or rucaparib versus placebo, olaparib versus single agent chemotherapy, iniparib + gemcitabine / carboplatin (GC) versus GC, veliparib + C versus C and olaparib + paclitaxel versus paclitaxel. The RR of all-grade side effects were as follows: diarrhea, 1.24 (95% CI: 1.08 – 1.42, P = 0.002); nausea, 1.53 (95% CI: 1.16 – 2.02, P = 0.002); vomiting, 1.46 (95% CI: 1.02 – 2.08, P = 0.03); elevated AST, 1.25 (95% CI: 0.58 – 2.67, P = 0.55); and elevated ALT, 1.61 (95% CI: 0.81 – 3.20, P = 0.16). The RR of high-grade side effects were as follows: diarrhea, 1.08 (95% CI: 0.52 – 2.24, P = 0.82); nausea, 1.81 (95% CI: 0.79 – 4.12, P = 0.15); vomiting, 1.99 (95% CI: 1.06 – 3.73, P = 0.03); elevated AST, 1.86 (95% CI: 0.45 – 7.55, P = 0.38); and elevated ALT, 1.33 (95% CI: 0.42 – 4.18, P = 0.62). Conclusions: Our study showed that the risk of developing all grades of vomiting as well as any-grade nausea and diarrhea was high in PARP inhibitors arm, compared to control group. Timely recognition and prompt intervention with good supportive care are entailed.


PRILOZI ◽  
2019 ◽  
Vol 40 (3) ◽  
pp. 99-108
Author(s):  
Dafina Karadjova ◽  
Mirjana Shosholcheva ◽  
Еmilija Ivanov ◽  
Аtanas Sivevski ◽  
Ivo Kjaev ◽  
...  

Abstract Introduction: Epidural analgesia is considered a gold standard in obstetric anaesthesia and analgesia. However, in situation when it is contraindicated, unwanted by the patient or simply unavailable, remifentanil can be an excellent alternative. The goal of our study is to analyse the side effects of intravenous patient-controlled analgesia (IV PCA) with remifentanil compared with epidural analgesia during delivery. Material and methods: This study included 155 pregnant women in term for birth, divided into 2 groups: a remifentanil group (RG), and an epidural group (EG). Patients in the RG received intravenous PCA with remifentanil, while patients in the ЕG received epidural analgesia with programmed intermittent bolus dosing. Our primary outcome was maternal safety; the secondary outcome was neonatal safety. Results: The results present a significantly lower SaO2 value of the parturients in the RG (96.95 ± 1.4 vs 98.22 ± 0.6), and a significantly higher respiratory rate per minute in the EG at all time points after the onset of analgesia (20.85 ± 1.4 vs 18.67 ± 0.9). There was more frequent sedation, nausea and vomiting in the RG, while in the EG there was a more elevated temperature, itching and irregularities in the CTG record. Regarding the newborn, there was no significant difference between the two groups in the Apgar scores, pH, pCO2, pO2, and bicarbonate, while there was a significantly lower value of the base excess in the RG group. Conclusion: PCA with remifentanil is safe for the mother, foetus and the newborn, with minimal side effects. Continuous respiratory monitoring, oxygen supply and following of all consensus recommendations are mandatory.


BMJ Open ◽  
2021 ◽  
Vol 11 (9) ◽  
pp. e046113
Author(s):  
Elizabeth Osei ◽  
Adrienne Zandbergen ◽  
Paul J A M Brouwers ◽  
Laus J M M Mulder ◽  
Peter Koudstaal ◽  
...  

IntroductionImpaired glucose tolerance (IGT) is highly prevalent after stroke and is associated with recurrent stroke and unfavourable outcome.ObjectivesWe aimed to assess the feasibility, safety and effects on glucose metabolism of metformin or sitagliptin in patients with transient ischaemic attack (TIA) or minor ischaemic stroke and IGT.DesignWe performed a multicentre, randomised, controlled, open-label phase II trial with blinded outcome assessment.InterventionsPatients were randomised in a 2:1:1 ratio to ‘no medication’, sitagliptin or metformin.Primary and secondary outcome measuresPrimary outcome measures were baseline adjusted differences of 2-hour postload glucose; secondary outcome measures fasting glucose, glycosylated haemoglobin 1c (HbA1c) levels, tolerability and safety of metformin and sitagliptin at 6 months. Patients on metformin or sitagliptin were contacted by telephone for recording of possible adverse events and to support continuation of treatment at 2 weeks, 6 weeks and 3 months after inclusion. These events were not analysed as outcome measures.ResultsFifty-three patients were randomised to control group, 26 to metformin and 22 to sitagliptin. We found no significant differences in 2-hour postload glucose between patients on antidiabetic drugs and controls ((−0.04 mmol/L (95% CI −0.53 to 0.45)). Patients in the treatment arms had reduced fasting glucose: ((−0.21 mmol/L (95% CI −0.36 to −0.06)) and HbA1c levels ((−1.16 mmol/mol (95% CI −1.84 to −0.49)). Thirteen patients (50%) on metformin and 7 (32%) on sitagliptin experienced side effects. Sixteen patients (61%) in the metformin and 13 (59%) in the sitagliptin group were still on treatment after 6 months.ConclusionsMetformin and sitagliptin were both effective in reducing fasting glucose and HbA1c levels in patients with recent TIA or minor ischaemic stroke and IGT. However, the reduction of glucose levels and sample size was relatively small. The clinical relevance, therefore, needs to be tempered. A phase III trial is needed to investigate whether medical treatment, compared with lifestyle intervention or a combination of both, not only improves glucose metabolism in IGT, but also leads to reduction of recurrent TIA or ischaemic stroke in these patients.Trial registration numberNL3048.


2015 ◽  
Vol 1 (1) ◽  
Author(s):  
Judit Martinez-Abreu ◽  
Nelia Guerra-Fonten ◽  
Antonio Blanco-Garcia ◽  
Sandra Naranjo-Rodrigo ◽  
Eduardo Llanes-Llanes ◽  
...  

Alveolitis is a reversible infection of alveolar process after tooth extraction. Its etiology is unknown, but there are factors increasing its incidence such as traumatisms, infections, decrease of vascular supply of surrounding bone and general systemic status. Aimed at comparing the efficacy of OLEOZON® (ozonated sunflower oil) with Alvogil, treating alveolitis clinically and microbiologically and determining the degree of patients´ satisfaction and side effects. A controlled, randomized, single.blind, phase III clinical trial was conducted at “Reynold García” Polyclinic, Matanzas municipality (Cuba), between January 2007 and May 2010. The sample included 100 adult patients, aging from 20 to 59 years, with diagnostic criterion of alveolitis; 50 patients in the experimental group, to which were applied OLEOZON® and in the other 50 patients, Alvogil, a conventionally used medication of well-known efficacy. Cures were made every 72 hours as well as many visits as necessary to the dentist’s office. Healing criterion was formation of granulation tissue and pain relief. Patients were recovered with OLEOZON® by 92% and with Alvogil, by 78%, in the third visit, with significant differences between both groups. The majority of patients needed from 2 to 3 visits to the dentist’s office in both groups, though it was observed that there was a greater number of patients recovered in the group treated with OLEOZON® in the second visit, with significant differences regarding the control group. OLEOZON® proved better efficacy than Alvogil. No side effects against the medication under study were observed.


2020 ◽  
Vol 46 (Supplement_1) ◽  
pp. S229-S229
Author(s):  
Han Rong

Abstract Background Electroconvulsive therapy (ECT) is an rapid and effective treatment for schizophrenia patients, ECT may achieve significant antipsychotic effects in the several initial sessions, but significant side effects limit its use. However, our low-charge electrotherapy (LCE) pilot trial demonstrated antipsychotic effects with significantly fewer side effects. The aim of this trial is to propose a novel two-step charge set strategy for ECT treatment, referred to as Hybrid-ECT, try to decrease side effects by using a lower charge while preserving treatment efficacy. Methods A randomized, double-blinded, standard-controlled, parallel-group design will be used. We plan to enroll 62 inpatients diagnosed with acute schizophrenia and randomly assign them to routine ECT (control group) or to Hybrid-ECT (treatment group, 3 ECT sessions followed by LCE sessions (approximately half of seizure threshold per session)). The primary outcome measure is the change in total PANSS score after the last ECT/LCE session. The secondary outcome measures include the response rate, remission rate, CGI, auditory hallucination rating scale, and everyday memory questionnaire (EMQ) scales. Neuropsychological metrics include the repeatable battery for the assessments of neuropsychological status (RBANS) and the stroop test, and detailed side effects will be evaluated. Structure and functional magnetic resonance imaging (MRI) assessments during treatment will be performed to explore brain changes between ECT and hybrid-ECT groups. The follow-up phase is set at the one-month after the last ECT/LCE session Results No results. Discussion This research will propose a simple but completely novel ECT strategy that aims to rapidly relieve psychosis symptoms and minimize side effects. If Hybrid-ECT is found to have the potentiality mentioned above, this could have important implications for future ECT strategies in treating schizophrenia patients in the acute phase. In addition, by using the detailed neuropsychological assessments and MRI scanning, this study may improve the knowledge of ECT-related antipsychotic mechanisms.


VASA ◽  
2011 ◽  
Vol 40 (3) ◽  
pp. 235-240 ◽  
Author(s):  
Krnic ◽  
Sucic

Background: The aim of this study is to report our results in main stem vein closure using the bipolar radiofrequency induced thermotherapy (RFITT) system and the 1064nm Nd:Yag laser. Patients and methods: 44 incompetent main stem veins (37 great saphenous veins, one lesser saphenous vein, and 6 anterior accessory saphenous veins) in 29 patients were treated using RFITT. 53 incompetent main stem veins (45 great saphenous veins, 4 lesser saphenous veins, and 4 anterior accessory saphenous veins) in 43 patients were treated endovenously with 1064 nm Nd:Yag laser. All patients underwent postoperative duplex scanning within a month after procedure, as well as a short interview regarding postoperative discomfort. Results: In main stem veins treated with RFITT, the success rate within the first month was 86,4 % (38 out of 44 veins). Complete failure rate was 13,6 % (6 out of 44 veins). In 53 main stem veins treated by 1064 nm Nd:Yag laser, the success rate was 100 %, consisting of 98,1 % complete success (52/53 veins), and 1,9 % partial success (1/53 veins). None of the patients treated with RFITT experienced postoperative adverse effects, whereas 13/43 (30,2 %) patients treated with laser had to use oral analgesics after the treatment, and 21/43 (48,8 %) patients reported transient skin changes, such as bruising or skin redness. Conclusions: RFITT system was fairly efficient in the short term for closure of main trunk veins, whereas longer term results are still scarce. Postoperative side effects of RFITT were minimal. 1064nm Nd:Yag laser, according to short term results, proved to be very effective for main stem vein closure. Postoperative side effects related to 1064 nm Nd:Yag endovenous laser treatment proved to be minor, transient, and acceptable.


2016 ◽  
Vol 1 (1) ◽  
pp. 22
Author(s):  
Nazli Zainuddin ◽  
Nurul Azira Mohd Shah ◽  
Rosdan Salim

Introduction: The role of virgin coconut oil in the treatment of allergic rhinitis is controversial. Thus, the aim of the present study is to determine the effects of virgin coconut oil ingestion, in addition to standard medications, on allergic rhinitis. We also studied the side effects of consumption of virgin coconut oil. Methods: Fifty two subjects were equally divided into test and control groups. All subjects received a daily dose of 10mg of loratadine for 28 days. The test group was given 10ml of virgin coconut oil three times a day in addition to loratadine. The symptoms of allergic rhinitis were scored at the beginning and end of the study. Results:, the symptom score were divided into nasal and non-nasal symptom scores. Sneezing score showed a significant difference, however the score was more in control group than test group, indicating that improvement in symptom was more in control group. The rest of the nasal symptom and non-nasal symptom score showed no significant difference between test and control groups. Approximately 58% of the test subjects developed side effects from consumption of virgin coconut oil, mainly gastrointestinal side effects. Conclusion: In the present study, ingestion of virgin coconut oil does not improve the overall and individual symptoms of allergic rhinitis, furthermore it has side effects.


2020 ◽  
Vol 2 (1) ◽  
pp. 36-44
Author(s):  
Satyawan G. Damle ◽  
Ritika Bansal ◽  
Dhanashree D. Sakhare

Objective: To compare the success rate of different obturation procedures in primary mandibular second molars clinically and also by digital radiovisiography. Methods: A total of 40 children aged between 4-8 years with deeply carious mandibular second primary molars indicated for single session pulpectomy were selected. Canals were obturated with Metapex. The 3 study groups (Endodontic plugger, Handheld lentulospiral, Navi Tip syringe) were compared with the control group (reamer) both clinically and radiovisiographically. The data collected were statistically analyzed using Pearson’s Chi-square and Fisher’s exact test. Results: The use of Navi tip syringe led to the least number of voids followed by Endodontic plugger and Reamer and the highest number of voids was reported with Lentulospiral. Navitip presented maximum number of optimally filled cases followed by Endodontic plugger and Lentulospiral and least number of optimally filled cases with reamer. However, there was no statistically significant difference (p>0.05) in any of the groups with clinical (pain and tenderness to percussion) and radiographic parameters (presence or absence of voids and length of obturation). Conclusion: Within the limitations of the present study, though the clinical outcome was statistically insignificant, Navitip syringe exhibited encouraging results and is a promising option for obturation in primary teeth.


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