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Mother Lactation in The Postpartum Period (lactation)

16 de dezembro de 2013 atualizado por: yavuz demiraran, Duzce University

Effects of Different Anesthesia Protocols on Mother Lactation in The Postpartum Period

In our study we aimed to compare the lactation process by mothers who were undergoing elective Caesarian section under general anesthesia, spinal anesthesia, epidural anesthesia and normal vaginal birth.

Visão geral do estudo

Status

Concluído

Descrição detalhada

Patients were randomly divided into 4 groups: group G (general anesthesia for Caesarean section, n=21), group S (spinal anesthesia for Caesarean section, n=21), group E (epidural anesthesia for Caesarean section, n=21), group V (normal vaginal birth without anesthesia, n=21). Blood sample of 3 mililiters was taken from all patients 2,5 hours before procedure and oxytocin and prolactin levels in this blood samples were determined. No patient received premedication. Group G (general anesthesia for Caesarean section) received preoxygenation with 100% oxygen for 3-5 minutes before intubation. In order to let fetus minimally affected by the anesthetic agents, induction was performed after the disinfection and covering up of surgery area. Induction was performed with propofol (2 mg/ kg) and rocuronium (0,6 mg/kg). After onset of neuromuscular block, patients were intubated with compression maneuver of cricoid cartilage. Controlled ventilation was provided with anesthesia machine Datex Ohmeda S/5 Avance with tidal volume of 8-10 ml/kg, respiration frequency of 10-12 min. Anesthesia was maintained with oxygen (50%) , air (50%), sevoflurane of 1 MAC. When necessary rocuronium 0,15 mg/kg was administered. After delivery of the newborn, fentanyl 1-1,5 mcg/ kg was administered.

Patients in group S (spinal anesthesia for Caesarean section) received 750-1000 mL of 0,9% NaCI solution (10-15 mL/kg) as infusion in 20-30 minutes. Under strict aseptic precautions a 25G Quincke spinal needle was introduced into L3-L4 or L4-L5 intervertebral space in midline approach in sitting posture, and, after confirming free flow of CSF, predetermined 10-11 mg of drug solution (hypertonic bupivacaine 0,5%) was injected. We let the operation begin when sensory and motor blockade were verified. Oxygen of 100% (3 L. min) was administered throughout the operation via nasal cannula.

Patients in group E (epidural anesthesia for Caesarean section) received 750-1000 mL of 0,9% NaCI solution (10-15 mL/kg) as infusion in 20-30 minutes. We conducted epidural anesthesia with 18-gauge Tuohy needle at L3-L4 or L4-L5 epidural space by midline approach at sitting position. 3 -5 minutes after injection of 3 ml lidocaine as test-dose, when the patient has no sign of subarachnoid injection like prickling in lower extremities or of intravascular injection like nausea, vomiting, tachicardia, tinnitus, a 20-gauge epidural catheter was inserted to cephalad. We injected 10 ml of 0.5% bupivacaine via epidural catheter. We let the operation begin when sensory and motor blockade were verified. Oxygen of 100% (3 L. min) was administered throughout the operation via nasal cannula.

Patients in all 3 groups were monitorised in the operation room with a monitor of Datex-Ohmeda and electrocardiogram (ECG), systolic blood pressure (SBP), diastolic blood pressure (DBP), mean blood pressure (MBP), heart rate (HR), peripheral oxygen saturation (SPO2) were recorded. Efedrin 5-10 mg and/or atropin 0,5 mg was administered when significant hypotension and bradicardia occurred. After delivery of the newborn 30 IU of oxytocin in a 1000cc solution of 0,9% NaCI was infused and if patient was not hypertensive, methylergonovine of 0,2 mg was administered intramuscular.

Patients in group V (spontaneous vaginal birth without anesthesia) were spectated by gynecologists in the Clinic of Gynecology and Obstetrics during the delivery. They received no anesthesia.

In all groups blood samples were taken at the 24th hour after delivery and oxytocin and prolactin levels were measured. Plasma of blood samples taken before and after delivery were stored at a temperature of -80°C. Prolactin levels were determined with chemiluminescense immunoassay technique Cobas e 601 (Roche® Diagnostics, Mannheim, Germany) using a commercial kit (Roche®). Oxytocin levels were determined with a commercial ELISA kit (Cusabio Biotech CO. Ltd). By all patients onset time of lactation was recorded.

Tipo de estudo

Observacional

Inscrição (Real)

84

Contactos e Locais

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Locais de estudo

      • Duzce, Peru, 81620
        • Anesthesiology Department

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos a 40 anos (Adulto)

Aceita Voluntários Saudáveis

Sim

Gêneros Elegíveis para o Estudo

Fêmea

Método de amostragem

Amostra de Probabilidade

População do estudo

84 patients were included. 63 of them were undergoing elective caesarian section and 21 patients had normal vaginal delivery in the Clinic of Gynecology and Obstetrics. All patients were between 18-40 years old and with the risk of ASA II.

Descrição

Inclusion Criteria:

  • elective caesarian section
  • normal vaginal delivery.
  • between 18-40 years old
  • risk of American society of anesthesiology grade-2

Exclusion criteria :

  • Non-elective cases, plural pregnancies,
  • Preterm pregnancies,
  • Fetal anomalies,
  • Retardation of fetal development,
  • Newborns with birthweight under 2500 grams,
  • Infants with risk of aspiration of meconium or amnios,
  • Pathologies affecting acid-base balance,
  • Diabetes mellitus,
  • Hypertension,
  • Antepartum hemorrhage,
  • COPD (chronic obstructive pulmonary disease),
  • Rhesus incompatibility,
  • Obstetric complications like congenital malformations,
  • History of malignant hypertermia,
  • Morbid obesity, opioid sensitivity,
  • Alcohol or drug addiction,
  • Diseases of coronary arteria,
  • Congestive heart failure,
  • Serious anemia,
  • History of liver or kidney diseases,
  • Hypovolemia, hypotension,
  • Systemic inflammatory response syndrome,
  • Sepsis,
  • History of allergic reactions to drugs used in the study,
  • History of drugs affecting lactation.

Plano de estudo

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Como o estudo é projetado?

Detalhes do projeto

Coortes e Intervenções

Grupo / Coorte
group g
general anesthesia, n: 21
group S
spinal anesthesia, n: 21
group E
epidural anesthesia, n: 21
group V
vaginal birth, without anesthesia, n: 21

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
onset time of lactation of mothers
Prazo: 24 h
By all patients onset time of lactation was recorded postoperatively
24 h

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
hormon levels
Prazo: 24 h
In all groups blood samples were taken at the 24th hour after delivery and oxytocin and prolactin levels were measured. Plasma of blood samples taken before and after delivery were stored at a temperature of -80°C. Prolactin levels were determined with chemiluminescense immunoassay technique Cobas e 601 (Roche® Diagnostics, Mannheim, Germany) using a commercial kit (Roche®). Oxytocin levels were determined with a commercial ELISA kit (Cusabio Biotech CO. Ltd).
24 h

Outras medidas de resultado

Medida de resultado
Descrição da medida
Prazo
Apgar scores
Prazo: 5 min
Neonate APGAR Scores 1st and 5th minutes were recorded
5 min

Colaboradores e Investigadores

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Patrocinador

Investigadores

  • Diretor de estudo: Yavuz Demiraran, Duzce University School of Medicine

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo

1 de janeiro de 2011

Conclusão Primária (Real)

1 de janeiro de 2012

Conclusão do estudo (Real)

1 de fevereiro de 2012

Datas de inscrição no estudo

Enviado pela primeira vez

4 de dezembro de 2013

Enviado pela primeira vez que atendeu aos critérios de CQ

16 de dezembro de 2013

Primeira postagem (Estimativa)

20 de dezembro de 2013

Atualizações de registro de estudo

Última Atualização Postada (Estimativa)

20 de dezembro de 2013

Última atualização enviada que atendeu aos critérios de controle de qualidade

16 de dezembro de 2013

Última verificação

1 de dezembro de 2013

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • leylakutlucan
  • Duzce University (Outro identificador: Duzce University scientific research projects department)

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