Postpartum Women's Dexmedetomidine Sedation

NCT02111421 | Completed Phase 4

• 1 other identifier: Cesarean Surgery
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Currently, spinal anesthesia is most commonly used for cesarean section.But spinal anesthesia can not block the visceral vagus nerve, and the patients are prone to nausea, vomiting, chest tightness or other discomfort when the uterus is stretched .For parturients who have poor uterine contractions and are bleeding larger, obstetricians often use oxytocin to strengthen the contraction of the uterine,which also would increase the parturients' discomfort.Anesthesiologists often intravenous sedative hypnotics (eg.propofol or midazolam) to alleviate the fear of the parturients after the baby is delivered.One of the side effects of propofol or midazolam is that they would lead to the respiratory depression.For the poor respiratory reserve of the parturients, functional residual capacity(FRC) of this group could be reduced by up to 20%, and the oxygen consumption was also increased.The SPO2 could decline quickly intraoperatively.Dexmedetomidine is a novel , highly selective α2 adrenergic receptor agonists , and its selectivity for α2 receptor is 1600 times higher than α1.It also could provide dose-dependent sedation , analgesia , anti-anxiety and inhibition of sympathetic nerves and other effects.Because of its minimal impact on the respiratory , it could safely and effectively used to sedate patients undergoing cesarean section.But the change of endocrine system and hemodynamic of the parturients may affect the pharmacokinetics and pharmacodynamics of some anesthetic drugs.Currently studies have demonstrated the increased sensitivity of some anesthetic drug in parturients, such as lidocaine and isoflurane.The study is aim to explore the optimal dexmedetomidine dose to produce suitable sedation in parturients ,and compared with norman nonpregnant women.

Conditions

Cesarean Section

Keywords

dexmedetomidine; parturient; nonpregnant women; sedation

Outcome Measures

Primary Outcomes (1)

• The assessment of sedation

  The aim of our study is to define the median effective sedative dose (ED50) of dexmedetomidine for providing adequate sedation in cesarean surgery,using the Dixon up-and-down method. Adequate sedation was defined as an OAA/S≤3 at any assessment time point during the 30 min after dexmedetomidine infusion.

  every 5 min after starting the dexmedetomidine infusion for 30 min

Secondary Outcomes (1)

• comparision of ED50

  every 5 min after starting the dexmedetomidine infusion for 30 min

Study Arms (2)

parturients

EXPERIMENTAL

Parturients after the umbilical cord was clapped in cesarean section were accepted an initial dose of 1.0 μg/kg dexmedetomidine, with dose adjustment intervals of 0.1μg/kg in first three turning points and 0.05μg/kg in the last four turning points.

Drug: Dexmedetomidine 01

nonpregnant women

EXPERIMENTAL

Nonpregnant women were accepted an initial dose of 1.0 μg/kg dexmedetomidine, with dose adjustment intervals of 0.1μg/kg in first three turning points and 0.05μg/kg in the last four turning points.

Drug: Dexmetomidine 02

Interventions

Dexmedetomidine 01 DRUG

Initial dose of dexmedetomidine was 1.0 μg/kg, with dose adjustment intervals of 0.1μg/kg in first three turning points and 0.05μg/kg in the last four turning points,after the umbilical cord was clapped.The wight used to calculate the dose of dexmedetomidine would be that the total weight of the mother minus the weight of the placenta, amniotic fluid and fetal.

parturients

Dexmetomidine 02 DRUG

Initial dose of dexmedetomidine was 1.0 μg/kg, with dose adjustment intervals of 0.1μg/kg in first three turning points and 0.05μg/kg in the last four turning points,as soon as the spinal anesthesia

nonpregnant women

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• ASA Ⅰ \~ Ⅱ women undergoing cesarean surgery under spinal anesthesia
• ASA Ⅰ \~ Ⅱ nonpregnancy women undergoing lower abdominal surgery under spinal anesthesia
• Written informed consent from the patient or the relatives of the participating patient
• nonpregnancy women BMI:18～25 kg/m2 , parturients BMI \<35kg/m2

You may not qualify if:

• Mental illness can not match
• Spinal anesthesia contraindicated
• People who have Slow-type arrhythmias
• People who were language or hearing impaired
• Sensory block reached to T6 or higher.
• People who had lung infection or sleep apnea syndrome.
• Chronic renal failure
• Alcohol or drug abuse
• Already taking gabapentin, pregabalin, benzodiazepin or antidepression drug

Sponsors & Collaborators

• Guangzhou General Hospital of Guangzhou Military Command: lead

Study Sites (1)

Guangzhou Military Region General Hospital, Department of Anesthesiology

Guangzhou, Guangdong, 510010, China

Location

Related Publications (1)

• Xiong M, Chen B, Hu Z, Gupta S, Li Z, Liu J, He J, Patel S, Eloy JD, Xu B. Dose Comparison of Dexmedetomidine Sedation following Spinal Anesthesia: Parturient versus Nonpregnant Women-A Randomized Trial. Anesthesiol Res Pract. 2020 Jul 27;2020:1059807. doi: 10.1155/2020/1059807. eCollection 2020.

  PMID: 32802051 DERIVED

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate chief physician

Study Record Dates

• First Submitted: April 7, 2014
• First Posted: April 11, 2014
• Study Start: June 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: April 1, 2016
• Last Updated: November 28, 2017

Record last verified: 2017-11

Locations

CN (1)