Ignite Creation Date:
2024-05-06 @ 12:06 PM
Last Modification Date:
2024-10-26 @ 12:54 PM
Study NCT ID:
NCT03672734
Status:
UNKNOWN
Last Update Posted:
2019-04-04
First Post:
2018-08-31
Brief Title:
Volume and pH of Gastric Contents in Patients Undergoing Gynecologic Laparoscopic Surgery During Emergence From General Anesthesia
Sponsor:
Siriraj Hospital
Organization:
Siriraj Hospital
Study Overview
Official Title:
Observed Volume and pH of Gastric Contents in Patients Undergoing Gynecologic Laparoscopic Surgery During Emergence From General Anesthesia
Status:
UNKNOWN
Status Verified Date:
2018-09
Last Known Status:
ENROLLING_BY_INVITATION
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:
Complications during general anesthesiainduction period difficult airway hypotension upper airway obstruction laryngospasm pulmonary aspiration Maintenance period hypotension hypertension awareness bronchospasm pulmonary aspiration
Emergence period delayed emergence upper airway obstruction pulmonary aspiration
Pulmonary aspiration occur all ranges of general anesthesia Because the patients can not protected themselves due to anesthetic medication example volatile agent opioidThis can cause decrease consciousness delayed gastric emptying time Incidence of pulmonary aspiration was 1 900 - 1 10000 of general of anesthesia induction 20 emergence 80 Anesthesia Service in Siriraj Hospital 2017 6 25000 case Pathophysiology of pulmonary aspiration
Pulmonary aspiration is defined as inhalation of oropharynx or stomach contents through the larynx to low respiratory tract Aspiration pneumonitis is the inflammation of the lung caused by aspirating or inhaling irritants Mendelsons syndrome
Gastric acid is a digestive fluid formed in the stomach and is composed of hydrochloric acid potassium chloride and sodium chlorideThe highest concentration of gastric acid is 140-160 mEqL The pH of gastric acid is 15-35 in the human stomach lumen
Risk factors for increased gastric contents full stomach delayed gastric emptying incompetent lower esophageal sphincter lithotomy position laparoscopy length of surgery more than 2 hr difficult airway
This study observed Volume and pH of Gastric Contents in Patients undergoing Gynecologic Laparoscopic Surgery during Emergence from General Anesthesia
Emergence period delayed emergence upper airway obstruction pulmonary aspiration
Pulmonary aspiration occur all ranges of general anesthesia Because the patients can not protected themselves due to anesthetic medication example volatile agent opioidThis can cause decrease consciousness delayed gastric emptying time Incidence of pulmonary aspiration was 1 900 - 1 10000 of general of anesthesia induction 20 emergence 80 Anesthesia Service in Siriraj Hospital 2017 6 25000 case Pathophysiology of pulmonary aspiration
Pulmonary aspiration is defined as inhalation of oropharynx or stomach contents through the larynx to low respiratory tract Aspiration pneumonitis is the inflammation of the lung caused by aspirating or inhaling irritants Mendelsons syndrome
Gastric acid is a digestive fluid formed in the stomach and is composed of hydrochloric acid potassium chloride and sodium chlorideThe highest concentration of gastric acid is 140-160 mEqL The pH of gastric acid is 15-35 in the human stomach lumen
Risk factors for increased gastric contents full stomach delayed gastric emptying incompetent lower esophageal sphincter lithotomy position laparoscopy length of surgery more than 2 hr difficult airway
This study observed Volume and pH of Gastric Contents in Patients undergoing Gynecologic Laparoscopic Surgery during Emergence from General Anesthesia
Detailed Description:
The study was approved from the Siriraj Institutional Review Board Si-IRB COA Certificate of AnalysisSi4372018 and was written informed consent was obtained from all subjects The study was conducted at the Department of Siriraj Obstetrics and Gynecology
A total of 100 patients were enrolled in the study between September 2018 and 2019 All patients underwent general anesthesia for elective gynecologic laparoscopic surgery Inclusion criteria were elective Cases laparoscopic surgery age 18-65 yearBMI30kgsqm Exclusion criteria were emergency Case full stomach Withdrawal or termination criterion was the difficult inserted orogastric tube
On the day of surgery participants signed the informed consent Record data consisted of NPO time premedication drug BMI having intravenous fluid All patients underwent general anesthesia after application of standard monitors anesthesia was induced with fentanyl 1-2 mcgkg or morphine 01-02 mgkg propofol 15-25 mgkgnimbex 1-15 mgkg or atracurium 06 mgkg Anesthesia was maintained with sevoflurane air o2
Gastric volume and PH were measured with PH meter measured at 1hr intervals until the end of surgery Intraoperative record medication for reduced gastric volume or PH
Postoperative data were record nausea or vomiting medication requirements
A total of 100 patients were enrolled in the study between September 2018 and 2019 All patients underwent general anesthesia for elective gynecologic laparoscopic surgery Inclusion criteria were elective Cases laparoscopic surgery age 18-65 yearBMI30kgsqm Exclusion criteria were emergency Case full stomach Withdrawal or termination criterion was the difficult inserted orogastric tube
On the day of surgery participants signed the informed consent Record data consisted of NPO time premedication drug BMI having intravenous fluid All patients underwent general anesthesia after application of standard monitors anesthesia was induced with fentanyl 1-2 mcgkg or morphine 01-02 mgkg propofol 15-25 mgkgnimbex 1-15 mgkg or atracurium 06 mgkg Anesthesia was maintained with sevoflurane air o2
Gastric volume and PH were measured with PH meter measured at 1hr intervals until the end of surgery Intraoperative record medication for reduced gastric volume or PH
Postoperative data were record nausea or vomiting medication requirements
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None