Effect of Dexmedetomidine on Parturient Undergoing Elective Cesarean Section.
NCT ID: NCT03805945
Last Updated: 2019-12-03
Study Results
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Basic Information
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COMPLETED
PHASE4
160 participants
INTERVENTIONAL
2019-06-01
2019-12-02
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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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).
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
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).
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
20 Years
40 Years
FEMALE
No
Sponsors
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The Affiliated Hospital of Xuzhou Medical University
OTHER
Responsible Party
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Principal Investigators
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Ming Yan, M.D/Ph.D
Role: STUDY_DIRECTOR
The Affiliated Hospital of Xuzhou Medical University
Locations
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The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China
Countries
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References
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Victora CG, Bahl R, Barros AJ, Franca 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):475-90. doi: 10.1016/S0140-6736(15)01024-7.
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.
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-Aug;93(4):356-364. doi: 10.1016/j.jped.2016.08.005. Epub 2016 Dec 26.
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/s12884-016-0876-1.
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.
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 2017 May 10.
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.2013.03.029. Epub 2013 Mar 27.
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: 10.1016/j.bja.2018.06.011. Epub 2018 Jul 31.
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 analysis of analgesic mechanisms. Pain. 2014 Mar;155(3):617-628. doi: 10.1016/j.pain.2013.12.018. Epub 2013 Dec 16.
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.
Wang Y, Fang X, Liu C, Ma X, Song Y, Yan M. Impact of Intraoperative Infusion and Postoperative PCIA of Dexmedetomidine on Early Breastfeeding After Elective Cesarean Section: A Randomized Double-Blind Controlled Trial. Drug Des Devel Ther. 2020 Mar 11;14:1083-1093. doi: 10.2147/DDDT.S241153. eCollection 2020.
Other Identifiers
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XYFY2019-KL054-02
Identifier Type: -
Identifier Source: org_study_id
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