Effect of Dexmedetomidine on Parturient Undergoing Elective Cesarean Section.

Cesarean Section Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03805945
• Other study ID #: XYFY2019-KL054-02
• Status: Completed
• Phase: Phase 4
• Start date: June 1, 2019
• Est. completion date: December 2, 2019

Study information

• Verified date: January 2019
• Source: The Affiliated Hospital of Xuzhou Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: December 2, 2019
• Est. primary completion date: December 2, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

Inclusion Criteria:

1. ASA class I or II

2. BMI?35kg/m2

3. Greater than 37 weeks gestation

4. Expressed a desire to breastfeed for a least 3 months postpartum

5. Elective cesarean section

Exclusion Criteria:

1. Intraspinal anesthesia contraindication

2. Twin or fetal Intrauterine distress

3. Preoperative history of application of analgesia or sedative drug

4. Severe cardiac and pulmonary dysfunction

5. History of neurological and psychiatric diseases

Related Conditions & MeSH terms

• Cesarean Section

Intervention

Drug:
• dexmedetomidine group
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).
• control group
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.

Locations

Country	Name	City	State
China	The Affiliated Hospital of Xuzhou Medical University	Xuzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
The Affiliated Hospital of Xuzhou Medical University

Country where clinical trial is conducted

China, 

References & Publications (10)

Ciechanowicz S, Setty T, Robson E, Sathasivam C, Chazapis M, Dick J, Carvalho B, Sultan P. Development and evaluation of an obstetric quality-of-recovery score (ObsQoR-11) after elective Caesarean delivery. Br J Anaesth. 2019 Jan;122(1):69-78. doi: 10.101 — View Citation

Funai Y, Pickering AE, Uta D, Nishikawa K, Mori T, Asada A, Imoto K, Furue H. Systemic dexmedetomidine augments inhibitory synaptic transmission in the superficial dorsal horn through activation of descending noradrenergic control: an in vivo patch-clamp — View Citation

Hobbs AJ, Mannion CA, McDonald SW, Brockway M, Tough SC. The impact of caesarean section on breastfeeding initiation, duration and difficulties in the first four months postpartum. BMC Pregnancy Childbirth. 2016 Apr 26;16:90. doi: 10.1186/s12884-016-0876- — View Citation

Lau Y, Wang Y, Yin L, Chan KS, Guo X. Validation of the Mainland Chinese version of the Edinburgh Postnatal Depression Scale in Chengdu mothers. Int J Nurs Stud. 2010 Sep;47(9):1139-51. doi: 10.1016/j.ijnurstu.2010.02.005. Epub 2010 Mar 12. — View Citation

Nie Y, Liu Y, Luo Q, Huang S. Effect of dexmedetomidine combined with sufentanil for post-caesarean section intravenous analgesia: a randomised, placebo-controlled study. Eur J Anaesthesiol. 2014 Apr;31(4):197-203. doi: 10.1097/EJA.0000000000000011. — View Citation

Schnabel A, Meyer-Frießem CH, Reichl SU, Zahn PK, Pogatzki-Zahn EM. Is intraoperative dexmedetomidine a new option for postoperative pain treatment? A meta-analysis of randomized controlled trials. Pain. 2013 Jul;154(7):1140-9. doi: 10.1016/j.pain.2013.03 — View Citation

Silva CS, Lima MC, Sequeira-de-Andrade LAS, Oliveira JS, Monteiro JS, Lima NMS, Santos RMAB, Lira PIC. Association between postpartum depression and the practice of exclusive breastfeeding in the first three months of life. J Pediatr (Rio J). 2017 Jul - A — View Citation

Victora CG, Bahl R, Barros AJ, França GV, Horton S, Krasevec J, Murch S, Sankar MJ, Walker N, Rollins NC; Lancet Breastfeeding Series Group. Breastfeeding in the 21st century: epidemiology, mechanisms, and lifelong effect. Lancet. 2016 Jan 30;387(10017):4 — View Citation

Xu H, Ding Y, Ma Y, Xin X, Zhang D. Cesarean section and risk of postpartum depression: A meta-analysis. J Psychosom Res. 2017 Jun;97:118-126. doi: 10.1016/j.jpsychores.2017.04.016. Epub 2017 Apr 24. Review. — View Citation

Yoshimura M, Kunisawa T, Suno M, Sugawara A, Kurosawa A, Nakanishi R, Aoki K, Toriumi T. Intravenous dexmedetomidine for cesarean delivery and its concentration in colostrum. Int J Obstet Anesth. 2017 Nov;32:28-32. doi: 10.1016/j.ijoa.2017.05.002. Epub 20 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	LATCH breastfeeding assessments	Day-1 LATCH (Latch, Audible swallowing, Type of nipple, Comfort, and Hold/help) breastfeeding assessments.	1st day postpartum
Secondary	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
Secondary	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