Effect of Dexmedetomidine on Parturient Undergoing Elective Cesarean Section.
- Conditions
- Cesarean Section
- Interventions
- Drug: dexmedetomidine groupDrug: control group
- Registration Number
- NCT03805945
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 160
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description dexmedetomidine group dexmedetomidine group 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). control group control group 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).
- Primary Outcome Measures
Name Time Method Self-reported exclusive breastfeeding at sixth week after caesarean section 6th week postpartum Self-reported exclusive breastfeeding at sixth week postpartum by telephone follow-up.If exclusive breastfeeding is discontinued, obtain the point of discontinuation.
Postpartum depression at sixth week after caesarean section 6th week postpartum 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.
- Secondary Outcome Measures
Name Time Method VAS score after cesarean section 6,12,24 and 48 hours 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.
Quality-of-recovery score Preoperative, 1st day and 2nd day postpartum 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.Hospital Anxiety and Depression Scale(HADS) score Preoperative, 1st day and 2nd day postpartum 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.LATCH breastfeeding assessments 1st day postpartum Day-1 LATCH (Latch, Audible swallowing, Type of nipple, Comfort, and Hold/help) breastfeeding assessments.
Trial Locations
- Locations (1)
The Affiliated Hospital of Xuzhou Medical University
🇨🇳Xuzhou, Jiangsu, China