Ignite Creation Date:
2024-05-06 @ 3:21 PM
Last Modification Date:
2024-10-26 @ 1:48 PM
Study NCT ID:
NCT04609124
Status:
COMPLETED
Last Update Posted:
2022-03-08
First Post:
2020-09-03
Brief Title:
Effect of Intravenous Metochlopramide Prophylaxis on Gastric Volume
Sponsor:
Assiut University
Organization:
Assiut University
Study Overview
Official Title:
the Effect of Intravenous Metochlopramide Prophylaxis on Gastric Volume and Antral Cross Sectional Area in Patients Awaiting for Caesarean Section a Randomized Double Blind Study
Status:
COMPLETED
Status Verified Date:
2022-02
Last Known Status:
None
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:
Gastric fluid volume and pH in patients undergoing cesarean section are essential considerations for general anesthesia GA Increased gastric volume and low pH of gastric contents could predispose the risk of aspiration pneumonitis The present study explored the research question whether prophylaxis with intravenous metoclopramide significantly reduces gastric volume and antral cross-sectional area in patients awaiting cesarean section under GA
Detailed Description:
Since regional anaesthesia has largely replaced general anaesthesia the risk of aspiration pneumonitis during caesarean sections has significantly decreased Nevertheless prophylaxis against gastric aspiration is still important in patients in whom regional anaesthesia is contraindicated or in whom general anaesthesia has to be administered for example during emergency caesarean delivery The administration of intravenous anaesthetics reduces the level of consciousness of a patient that compromises the protective reflexes of the upper airways Moreover a high level of sedation also reduces the tone of the LES lower oesophageal sphincter Both these situations predispose the risk of aspiration pneumonia in patients awaiting surgical interventions in supine position under general anaesthesia
The risk of aspiration increases in outpatients if the volume of the gastric contents increases beyond 25 ml and its pH falls below 25 However the risk of aspiration significantly decreases in fasted outpatients Since most patients awaiting elective surgery remains fasted routine prophylaxis for preventing aspiration pneumonitis is not recommended anymore
the administration of intravenous metoclopramide and cimetidine across patients n20 awaiting laparoscopic gynaecological surgery significantly increased the pH of the gastric contents in the intervention group compared to their control counterparts 61 versus 27 p005 The mean aspirated volumes were also significantly lower in the intervention group compared to their age-matched controls 69ml versus 153ml p005 Hong 2006 further showed that the percentage of individuals with high-risk gastric volume 25 ml and low pH 25 was higher in individuals who did not receive intravenous metoclopramide and cimetidine prior to surgery compared to their counterparts who received such interventions 20 versus 5 p005
The risk of aspiration increases in outpatients if the volume of the gastric contents increases beyond 25 ml and its pH falls below 25 However the risk of aspiration significantly decreases in fasted outpatients Since most patients awaiting elective surgery remains fasted routine prophylaxis for preventing aspiration pneumonitis is not recommended anymore
the administration of intravenous metoclopramide and cimetidine across patients n20 awaiting laparoscopic gynaecological surgery significantly increased the pH of the gastric contents in the intervention group compared to their control counterparts 61 versus 27 p005 The mean aspirated volumes were also significantly lower in the intervention group compared to their age-matched controls 69ml versus 153ml p005 Hong 2006 further showed that the percentage of individuals with high-risk gastric volume 25 ml and low pH 25 was higher in individuals who did not receive intravenous metoclopramide and cimetidine prior to surgery compared to their counterparts who received such interventions 20 versus 5 p005
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