Effect of Dexmedetomidine on Parturient Undergoing Elective Cesarean Section.

Study Overview
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Brief Summary
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The purpose of this study was to investigate whether dexmedetomidine used in the perioperative period of elective cesarean section can improve maternal mood, improve analgesic effect, improve maternal recovery quality, and then make the breastfeeding better.At the same time, this experiment attempts to explore the optimal dose of dexmedetomidine to produce the above effect.

Detailed Description
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After obtaining the informed consent, parturients were randomly divided into two groups according to the computer-generated random number table, namely, dexmedetomidine group and the control group.Spinal anesthesia is administered to all maternal women undergoing elective cesarean delivery. Immediately after the umbilicus is cut, the infusion of the experimental drug was started until the end of the operation, and the PCIA pump with the study medication is used during 2 days postoperatively.Continuous follow-up for three days after surgery.Follow-up personnel recorded LATCH score, VAS score, quality-of-recovery score and other indicators.In the 6th week after caesarean section, the outcome indicators were collected by electronic questionnaire and telephone follow-up.This randomized controlled trial is aims to prove that dexmedetomidine, used in parturient with elective cesarean section, can improve maternal mood and prolong the duration of breastfeeding.

Official Title
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Effects of Dexmedetomidine on Mood and Breastfeeding in Parturient Undergoing Elective Cesarean Section.

Conditions
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Cesarean Section

Intervention / Treatment
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* Drug: dexmedetomidine group
* Drug: control group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASA class I or II BMI≦35kg/m2 Greater than 37 weeks gestation Expressed a desire to breastfeed for a least 3 months postpartum Elective cesarean section Exclusion Criteria: Intraspinal anesthesia contraindication Twin or fetal Intrauterine distress Preoperative history of application of analgesia or sedative drug Severe cardiac and pulmonary dysfunction History of neurological and psychiatric diseases

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: dexmedetomidine group<br>After umbilical cord was cut, a loading dose of dexmedetomidine was pumped at 0.5ug/kg within 10min, followed by a further infusion of dexmedetomidine at 0.5ug /kg/h until the end of the surgery.Then connected with patient-controlled intravenous analgesia pump (dexmedetomidine 2ug/kg + sufentanil 1.5ug/kg + dolasetron 25mg/100ml saline). | Drug: dexmedetomidine group<br>* After the fetus was delivered, low-dose dexmedetomidine intraoperative infusion, postoperative low-dose dexmedetomidine patient-controlled intravenous analgesia pump(the background infusion is 2 ml/h, the bolus dose is 0.5 ml, the lock time is 15 min).<br>* Other names: D group;|
| Placebo Comparator: control group<br>Continuous infusion of saline after the umbilical cord was cut until the end of the operation.Then connected with patient-controlled intravenous analgesia pump (sufentanil 1.5ug/kg + dolasetron 25mg/100ml saline). | Drug: control group<br>* After the fetus was delivered, saline intraoperative infusion, postoperative patient-controlled intravenous analgesia pump(the background infusion is 2 ml/h, the bolus dose is 0.5 ml, the lock time is 15 min) without dexmedetomidine.<br>* Other names: C group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postpartum depression at sixth week after caesarean section | The Edinburgh Postnatal Depression Scale(EPDS) was used to determine the presence of postpartum depression through an electronic questionnaire in the sixth week after delivery. The Edinburgh Postnatal Depression Scale(EPDS) consists of 10 items. According to the severity of the symptoms, each item is scored in 4 levels (0, 1, 2, 3 points) with a cumulative maximum score of 30 points.In order to reduce the rate of missed diagnosis, we refer to the previous literature and use 10 points as the diagnostic threshold for postpartum depression. A score of 10 or more is considered as postpartum depression. | 6th week postpartum | 
| Self-reported exclusive breastfeeding at sixth week after caesarean section | Self-reported exclusive breastfeeding at sixth week postpartum by telephone follow-up.If exclusive breastfeeding is discontinued, obtain the point of discontinuation. | 6th week postpartum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital Anxiety and Depression Scale(HADS) score | Referring to the preoperative HADS score, the HADS on the second day after caesarean section were analyzed to judge the maternal emotional changes. The Hospital Anxiety and Depression Scale (HADS) includes two subscales of anxiety and depression, 7 questions per subscale, and 14 questions in total.Each question is divided into 4 score levels according to the severity (0, 1, 2, 3 points). The anxiety and depression subscales all use 8 points as the diagnostic threshold, and 8 or more points are considered to have anxiety or depression. The statistical analysis of this outcome indicator is mainly to regard the scale score as a continuous variable rather than a binary variable. | Preoperative, 1st day and 2nd day postpartum | 
| LATCH breastfeeding assessments | Day-1 LATCH (Latch, Audible swallowing, Type of nipple, Comfort, and Hold/help) breastfeeding assessments. | 1st day postpartum | 
| VAS score after cesarean section | The basic method of Visual Analogue Scale(VAS) is to use a ruler with a length of about 10 cm, the ruler is marked with 10 scales, and the ends are 0 and 10 respectively. 0 indicate no pain, and 10 indicate unbearable pain. Ask the parturient to mark the position on the ruler that represents her pain level. Follow-up personnel record pain scores based on the location of the marker. | 6,12,24 and 48 hours after cesarean section | 
| Quality-of-recovery score | Recovery quality assessment on the second day after delivery via the ObsQoR-11 scale. The ObsQoR-11 scale focuses on the following 11 items: nausea or vomiting, shivering, dizzy, in control, comfortable, able to hold baby, mobilising alone, personal hygiene, able to feed/nurse baby, moderate pain and severe pain. According to different degrees, each item can be divided into 0-10 points. | Preoperative, 1st day and 2nd day postpartum | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cesarean Section, Dexmedetomidine, Breast Feeding, Recovery quality