Clinical trial NCT03332901: Gastroesophageal Function During Anesthesia
Official title: To Monitor the Effect on the Laparoscopic Pneumoperitoneum of Gastroesophageal Function During Anesthesia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gastroesophageal Function During General Anesthesia
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2017-11-06
Enrollment: 15
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who will receive scheduled laparoscopic surgery under general anesthesia; Aged from 20-80 years old

Brief 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 ®AutoValve®IAP Monitoring Device before and after laparoscopic condition.

Detailed 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 ®AutoValve®IAP 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 ®AutoValve®IAP 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 ®AutoValve®IAP 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 ®AutoValve®IAP 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 ®AutoValve®IAP 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

- 1. 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

Primary outcomes:
measure: lower esophaegal sphincter pressure
timeFrame: during the anesthesia
Secondary outcomes:
measure: episodes of reflux
timeFrame: duirng the anesthesia
Other outcomes:
Locations:
city: Taipei, Taiwan
country: Taiwan
facility: Ya-Jung, Cheng
Study officials:
affiliation: anesthesiology of department, National Taiwan university hospital
name: Ya-Jung Cheng, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lai CJ, Chang WC, Huang CH, Liu CM, Lo YC, Cheng YJ. Detecting intraoperative gastric regurgitation by using preattached esophageal multichannel intraluminal impedance and pH monitoring on a solid-state manometry: a case series study. J Clin Monit Comput. 2020 Aug;34(4):853-859. doi: 10.1007/s10877-019-00380-2. Epub 2019 Aug 29.