Cesarean SectionPhase 4NCT02111421
Postpartum Women's Dexmedetomidine Sedation
A Phase 4 study testing Dexmedetomidine 01 and Dexmetomidine 02 in people with Cesarean Section, run by Guangzhou General Hospital of Guangzhou Military Command at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 35 years, women only
- Conditions the study is for
- Cesarean Section
- What is being tested?
- Dexmedetomidine 01 and Dexmetomidine 02
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Jun 2015to Apr 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
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- Chronic renal failure
- Alcohol or drug abuse
- Already taking gabapentin, pregabalin, benzodiazepin or antidepression drug
Trial locations and contacts
1 site in 1 country.
China1 site
Guangzhou Military Region General Hospital, Department of Anesthesiology
Guangzhou, Guangdong, 510010
About this study
Official title: Optimal Dose of Dexmedetomidine Sedation Following Spinal Anesthesia: Postpartum Versus Nonpregnant Women
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.
Read the detailed description
Parturients undergo cesarean section and normal nonpregnant women undergo lower abdominal surgery were scheduled . All patients accepted spinal anesthesia first.And then an dose of dexmedetomidine would be performed after umbilical cord was clapped in the parturients and in non-pregnant women group the dose of dexmedetomidine would be performed after the spinal anesthesia was conducted.Initial doses was 1.0μg/kg,with dose adjustment intervals of 0.1μg/kg in first three turning points and 0.05μg/kg in the last four turning points. Each patient's sedation state was assessed using the modified observer's assessment of awareness /sedation (OAA/S) scale every 5 min after starting the dexmedetomidine infusion for 30 min. Adequate sedation was defined as an OAA/S≤3 at any assessment time point during the 30 min
- Conditions
- Cesarean Section
- Being tested
- Dexmedetomidine 01, Dexmetomidine 02
- Keywords
- dexmedetomidine, parturient, nonpregnant women, sedation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexmedetomidine 01Drug
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.
Dexmetomidine 02Drug
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Dexmetomidine 02 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: every 5 min after starting the dexmedetomidine infusion for 30 min
Secondary outcomes (1)
comparision of ED50
compare the ED50 between postpartum parturients and nonpregnant women
Measured: every 5 min after starting the dexmedetomidine infusion for 30 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2014 (estimated)
- Study startJun 2015
- Primary completionMar 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cesarean SectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangzhou General Hospital of Guangzhou Military Command
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, bo xu, Guangzhou General Hospital of Guangzhou Military Command
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02111421
- Sponsor's protocol ID
- Cesarean Surgery
- Status last verified
- Nov 2017
- First submitted
- 7 Apr 2014
- Last updated
- 28 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 32802051
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Dose of Dexmedetomidine Sedation Following Spinal Anesthesia: Postpartum Versus Nonpregnant Women
- ClinicalTrials.gov ID
- NCT02111421
- Acronym / sponsor ID
- Cesarean Surgery
- Conditions
- Cesarean Section
- Keywords
- dexmedetomidine, parturient, nonpregnant women, sedation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Guangzhou General Hospital of Guangzhou Military CommandUniversity, hospital or other
- Study start
- Jun 2015 (actual)
- Primary completion
- Mar 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 11 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Parturients undergo cesarean section and normal nonpregnant women undergo lower abdominal surgery were scheduled . All patients accepted spinal anesthesia first.And then an dose of dexmedetomidine would be performed after umbilical cord was clapped in the parturients and in non-pregnant women group the dose of dexmedetomidine would be performed after the spinal anesthesia was conducted.Initial doses was 1.0μg/kg,with dose adjustment intervals of 0.1μg/kg in first three turning points and 0.05μg/kg in the last four turning points. Each patient's sedation state was assessed using the modified observer's assessment of awareness /sedation (OAA/S) scale every 5 min after starting the dexmedetomidine infusion for 30 min. Adequate sedation was defined as an OAA/S≤3 at any assessment time point during the 30 min
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| parturients | Experimental | Drug: Dexmedetomidine 01Parturients 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. |
| nonpregnant women | Experimental | Drug: Dexmetomidine 02Nonpregnant 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. |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexmedetomidine 01Initial 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. | Drug | parturients |
| Dexmetomidine 02Initial 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 | Drug | nonpregnant women |
Primary outcome
The assessment of sedation
Time frame: every 5 min after starting the dexmedetomidine infusion for 30 min
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.
1 secondary outcome
comparision of ED50
Time frame: every 5 min after starting the dexmedetomidine infusion for 30 min
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2017.
- Derived from this study: PubMed 32802051Xiong 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexmedetomidine 01 and Dexmetomidine 02 in people with Cesarean Section, run by Guangzhou General Hospital of Guangzhou Military Command at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The assessment of sedation (time frame: every 5 min after starting the dexmedetomidine infusion for 30 min). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02111421, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2017.