Gastroesophageal Function During Anesthesia

  • STATUS
    Recruiting
  • End date
    Dec 31, 2022
  • participants needed
    15
  • sponsor
    National Taiwan University Hospital
Updated on 1 March 2022

Summary

General anesthesia may predispose patients to aspiration of gastroesophageal contents because of depression of protective reflexes during loss of consciousness. The laparoscopy would increase the intra-abdominal pressure, which is regarded as a predisposing factor of gastroesophageal reflux during the anesthesia. The lower esophageal sphincter is the important physiological mechanisms that prevent regurgitation and aspiration. However, the change of LES pressure and gastroesophageal reflux before and after laparoscopic physiological condition is still unknown because the prospective evaluation of gastroesophageal function in human is limited. In addition, the relationship between the change of intra-abdominal pressure and the LES pressure were still unknown, too. In this study, we aimed to observe the changes of gastroesophgeal function parameters by esophageal manometry, pH impedance, and intra-abdominal pressure measured by AbViser AutoValveIAP Monitoring Device before and after laparoscopic condition.

Description

Background: General anesthesia may predispose patients to aspiration of gastroesophageal contents because of depression of protective reflexes during loss of consciousness. The laparoscopy would increase the intra-abdominal pressure, which is regarded as a predisposing factor of gastroesophageal reflux during the anesthesia. The lower esophageal sphincter is the important physiological mechanisms that prevent regurgitation and aspiration. However, the change of LES pressure and gastroesophageal reflux before and after laparoscopic physiological condition is still unknown because the prospective evaluation of gastroesophageal function in human is limited. In addition, the relationship between the change of intra-abdominal pressure and the LES pressure were still unknown, too.

The esophageal manometry has pressure sensor to measure the LES pressure. The AbViser AutoValveIAP Monitoring Device is a sterile non-invasive disposable monitoring device, that is routinely used to measure intra-abdominal pressure (IAP) in the intensive care unit. Therefore, application of esophageal manometry and pH impedance via second-generation SADs may help to detect gastroesophageal functional change and ongoing gastroesophageal regurgitation during perioperative period. We also used the AbViser AutoValveIAP Monitoring Device to monitor the change of IAP before and after laparoscopic condition. In this study, we aimed to observe the changes of gastroesophgeal function parameters by esophageal manometry and intra-abdominal pressure measured by AbViser AutoValveIAP Monitoring Device before and after laparoscopic condition.

Objectives: we aimed to observe the changes of gastroesophgeal function parameters by esophageal manometry, pH impedance, and intra-abdominal pressure measured by AbViser AutoValveIAP Monitoring Device before and after laparoscopic condition.

Patients and methods: Consecutive patients who will receive scheduled laparoscopic surgery under general anesthesia and aged >= 20 will be enrolled. All subjects provide basic demographic data and fill in standard symptom questionnaire for evaluation of baseline upper gastrointestinal symptoms. After induction, the endotracheal tube (ETT) will be inserted to establish airway. Then, the esophageal manometry would be inserted to monitor the LES, and the AbViser AutoValveIAP Monitoring Device will be inserted to monitor the IAP before and after the laparoscopic condition. After the surgery and removal of ETT, the patients will be followed for the oxygen saturation, sore throat or hoarseness in the postoperative care unit, as well as the possible complications.

Expected result: We will observe the changes of LES function, gastroesophageal reflux and the relationship between the IAP and the LES function before and after the laparoscopic condition.

Details
Condition Gastroesophageal Function During General Anesthesia
Treatment this is an observational study, no intervention required
Clinical Study IdentifierNCT03332901
SponsorNational Taiwan University Hospital
Last Modified on1 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

\. Patients who will receive scheduled laparoscopic surgery under general anesthesia 2\. Aged from 20-80 years old

Exclusion Criteria

\. Major systemic disease, such as congestive heart failure, liver cirrhosis, end stage renal disease and malignancy. 2. Patients who have the risk of difficult ventilation or intubation. 3. pregnant women 4. coagulopathy
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note