Ignite Creation Date:
2024-05-06 @ 3:55 PM
Last Modification Date:
2024-10-26 @ 1:59 PM
Study NCT ID:
NCT04801277
Status:
UNKNOWN
Last Update Posted:
2021-03-16
First Post:
2020-12-07
Brief Title:
Efficacy of PC6 Electroacupuncture in the Prevention of Nausea Vomiting in Caesarean Patient Under Spinal Anaesthesia
Sponsor:
Clinical Research Centre Malaysia
Organization:
Clinical Research Centre Malaysia
Study Overview
Official Title:
Efficacy of PC6 Electroacupuncture in the Prevention of Nausea Vomiting in Caesarean Patient Under Spinal Anaesthesia
Status:
UNKNOWN
Status Verified Date:
2021-03
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To determine the ability of electroacupuncture on PC6 versus sham acupuncture in reducing incidence of intraoperative and postoperative nausea vomiting in parturients who underwent Caesarean delivery under spinal anaesthesia
Detailed Description:
Caesarean rate in most countries are increasing year by year A report shows that the caesarean section rate for government hospitals in Malaysia was 105 in 2000 and 110 in 20011 and it rises to 25 of total delivery in Hospital Raja Permaisuri Bainun Malaysia in year 2018 Nowadays about 7 of all surgical procedures worldwide are caesarean section and the majority of them are performed with neuraxial blockade ie epidural anesthesia spinal anesthesia or a combined spinal-epidural anesthesia CSE
Nausea and vomiting are common intraoperative and postoperative complications in women having caesarean section under neuraxial anesthesiaCompared to the plethora of literatures about PONV little attention has been paid to nausea vomiting occurring during or after regional anesthesia These techniques gain increasing attention
Current literature review indicates a high incidence of IONV during CS under spinal anesthesia up to 804 The etiology of intraoperative and postoperative nausea and vomiting IONV and PONV is multifactorial Pregnant women are already likely to suffer from nausea and vomiting because of the pregnancy itself According to Apfels score predictive of PONV score that consists of four ascertained risk factors female non-smoker opioid use previous PONV events or motion sickness parturients often meet at least two of these criteria with their gender and non-smoker status
Despite the practice of prescribing antiemetic prophylaxis medication the incidence of nausea and vomiting in CS patient is still up to 30-506 The efficacy of antiemetic drugs is limited and their administration is not free from side effects Nausea and vomiting not only causes dehydration electrolyte imbalance and adversely affects wound healing but also leads to increased wound pain discomfort and anxiety among post partum patient This may further lead to increased medical expenses and extended hospital stay leaving patient with the overall negative surgical experience Hence the idea of multimodal therapy in prophylaxis of IONV and PONV arises
Non-pharmacological techiniques such as acupuncture acupressureand transcutaneous acupoint electrical stimulation of the pericardium 6PC6 Neiguan point have been studied for the prevention of PONV The increasing popularity of these modalities is in part due to their low cost simplicity and in obstetrics concern about placental transfer and secretion in breast milk of drugs
It is hypothesized that PC6 electroacupunture stimulation will reduce the incidence of IONV and PONV and reduce the usage of antiemetic drugs in post partum patient
Nausea and vomiting are common intraoperative and postoperative complications in women having caesarean section under neuraxial anesthesiaCompared to the plethora of literatures about PONV little attention has been paid to nausea vomiting occurring during or after regional anesthesia These techniques gain increasing attention
Current literature review indicates a high incidence of IONV during CS under spinal anesthesia up to 804 The etiology of intraoperative and postoperative nausea and vomiting IONV and PONV is multifactorial Pregnant women are already likely to suffer from nausea and vomiting because of the pregnancy itself According to Apfels score predictive of PONV score that consists of four ascertained risk factors female non-smoker opioid use previous PONV events or motion sickness parturients often meet at least two of these criteria with their gender and non-smoker status
Despite the practice of prescribing antiemetic prophylaxis medication the incidence of nausea and vomiting in CS patient is still up to 30-506 The efficacy of antiemetic drugs is limited and their administration is not free from side effects Nausea and vomiting not only causes dehydration electrolyte imbalance and adversely affects wound healing but also leads to increased wound pain discomfort and anxiety among post partum patient This may further lead to increased medical expenses and extended hospital stay leaving patient with the overall negative surgical experience Hence the idea of multimodal therapy in prophylaxis of IONV and PONV arises
Non-pharmacological techiniques such as acupuncture acupressureand transcutaneous acupoint electrical stimulation of the pericardium 6PC6 Neiguan point have been studied for the prevention of PONV The increasing popularity of these modalities is in part due to their low cost simplicity and in obstetrics concern about placental transfer and secretion in breast milk of drugs
It is hypothesized that PC6 electroacupunture stimulation will reduce the incidence of IONV and PONV and reduce the usage of antiemetic drugs in post partum patient
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None