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Mother Lactation in The Postpartum Period (lactation)

2013年12月16日 更新者: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.

調査の概要

状態

完了

条件

詳細な説明

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.

研究の種類

観察的

入学 (実際)

84

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

      • Duzce、七面鳥、81620
        • Anesthesiology Department

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年~40年 (大人)

健康ボランティアの受け入れ

はい

受講資格のある性別

女性

サンプリング方法

確率サンプル

調査対象母集団

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.

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

コホートと介入

グループ/コホート
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

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
onset time of lactation of mothers
時間枠:24 h
By all patients onset time of lactation was recorded postoperatively
24 h

二次結果の測定

結果測定
メジャーの説明
時間枠
hormon levels
時間枠: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

その他の成果指標

結果測定
メジャーの説明
時間枠
Apgar scores
時間枠:5 min
Neonate APGAR Scores 1st and 5th minutes were recorded
5 min

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

捜査官

  • スタディディレクター:Yavuz Demiraran、Duzce University School of Medicine

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

便利なリンク

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始

2011年1月1日

一次修了 (実際)

2012年1月1日

研究の完了 (実際)

2012年2月1日

試験登録日

最初に提出

2013年12月4日

QC基準を満たした最初の提出物

2013年12月16日

最初の投稿 (見積もり)

2013年12月20日

学習記録の更新

投稿された最後の更新 (見積もり)

2013年12月20日

QC基準を満たした最後の更新が送信されました

2013年12月16日

最終確認日

2013年12月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • leylakutlucan
  • Duzce University (その他の識別子:Duzce University scientific research projects department)

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