Ignite Creation Date:
2024-05-06 @ 7:56 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06192082
Status:
COMPLETED
Last Update Posted:
2024-02-20
First Post:
2023-11-27
Brief Title:
Adverse Cardiovascular Events During Painless Gastroscopy Diagnosis and Treatment in Elderly Frail Patients
Sponsor:
Beijing Friendship Hospital
Organization:
Beijing Friendship Hospital
Study Overview
Official Title:
Clinical Study About Impacts of Anesthesia Methods on Adverse Cardiovascular Events During Painless Gastroscopy Diagnosis and Treatment in Elderly Frail Patients
Status:
COMPLETED
Status Verified Date:
2023-11
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:
frail
Brief Summary:
This study aims to compare the effects of conscious sedation and intravenous general anesthesia on cardiovascular events in frail patients undergoing digestive endoscopy diagnosis and treatment
Detailed Description:
This study aims to compare the effects of conscious sedation and intravenous general anesthesia on cardiovascular events in frail patients undergoing digestive endoscopy diagnosis and treatment
Both sets of anesthesia plans completed preoperative evaluations including blood count coagulation function liver and kidney function and cardiopulmonary function Routine monitoring of electrocardiograms ECG non-invasive blood pressure NIBP pulse oximetry SpO2 open veins and administration of a balance solution of 3-5mlkg h The conscious sedation group Group A received sufentanil 005-01 5 minutes before examination μ Gkg administration time 30 seconds 1-2 mg of midazolam administered 2 minutes before examination Evaluate the patients MOAAS score insert a digestive endoscope at 2-3 minutes and add 1-2mg of midazolam if the patient is unable to tolerate coughing or movement during the examination Reevaluate the MOAAS score and continue the operation after 2-3 minutes Intravenous general anesthesia group Group B sufentanil 005-01 μ Gkg administration time 30 seconds 1mgkg of propofol administered 2 minutes before examination Depending on the patients sleep status 10mg of propofol can be administered every 30 seconds Evaluate the patients MOAAS score At 0-1 points a digestive endoscope is inserted If there is coughing or physical activity during the examination that the patient cannot tolerate propofol 10-20mg can be administered multiple times Evaluate the MOAAS score again and continue the operation after 0-1 points All anesthetics should be discontinued before the end of the surgery Since the examination blood pressure should be measured every 2 minutes while HR SpO2 and RR should be recorded to observe if there are any abnormalities in the electrocardiogram If there are any abnormalities please explain until the endoscope is removed from the dental pad Record the satisfaction of gastroenterologists anesthesiologists and patients after surgery Follow up patients by phone within three days after surgery to determine the incidence of adverse events dizziness headache palpitations wheezing mobility nausea and vomiting
Both sets of anesthesia plans completed preoperative evaluations including blood count coagulation function liver and kidney function and cardiopulmonary function Routine monitoring of electrocardiograms ECG non-invasive blood pressure NIBP pulse oximetry SpO2 open veins and administration of a balance solution of 3-5mlkg h The conscious sedation group Group A received sufentanil 005-01 5 minutes before examination μ Gkg administration time 30 seconds 1-2 mg of midazolam administered 2 minutes before examination Evaluate the patients MOAAS score insert a digestive endoscope at 2-3 minutes and add 1-2mg of midazolam if the patient is unable to tolerate coughing or movement during the examination Reevaluate the MOAAS score and continue the operation after 2-3 minutes Intravenous general anesthesia group Group B sufentanil 005-01 μ Gkg administration time 30 seconds 1mgkg of propofol administered 2 minutes before examination Depending on the patients sleep status 10mg of propofol can be administered every 30 seconds Evaluate the patients MOAAS score At 0-1 points a digestive endoscope is inserted If there is coughing or physical activity during the examination that the patient cannot tolerate propofol 10-20mg can be administered multiple times Evaluate the MOAAS score again and continue the operation after 0-1 points All anesthetics should be discontinued before the end of the surgery Since the examination blood pressure should be measured every 2 minutes while HR SpO2 and RR should be recorded to observe if there are any abnormalities in the electrocardiogram If there are any abnormalities please explain until the endoscope is removed from the dental pad Record the satisfaction of gastroenterologists anesthesiologists and patients after surgery Follow up patients by phone within three days after surgery to determine the incidence of adverse events dizziness headache palpitations wheezing mobility nausea and vomiting
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