Gastroesophageal Regurgitation Under General Anesthesia

NCT ID: NCT02810912

Last Updated: 2016-06-23

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-06-30

Brief Summary

Gastric regurgitation increases the risk of pulmonary aspiration in surgical patients receiving general anesthesia because of depression of gastro-esophageal reflux. In addition, some patients may have higher risk of aspiration as a result of reduced gastric emptying and gastroesophageal reflux, prolonged surgical time, and laparoscopic surgery. Second-generation supraglottic airway device (SAD) provides an additional channel to facilitate the drainage the gastric content to prevent from aspiration, which was routinely used in surgeries. Currently, multichannel intraluminal impedance-pH (MII-pH) monitoring, which combines multiple impedance channels to conventional pH catheters, is regarded as the most sensitive technique for detecting reflux events. Therefore, application of MII-pH monitoring on the SAD-based general anesthesia may help to detect ongoing reflux/regurgitation in the esophagus of patients during perioperative period. The hypothesis of the present study is that the occurrences of gastroesophageal regurgitation during general anesthesia may be influenced by the several factors, such as abdominal insufflation during laparoscopy, longer surgical time, Trendelenburg position, higher body weight, etc.

Detailed Description

Investigators aim to observe the occurrences of gastroesophageal regurgitation through the continuous monitoring with the novel technique of MII-pH during the perioperative period of a variety of common surgical procedures under SAD-based general anesthesia in this pilot study. Furthermore, investigators will also determine the factors associated with the occurrence of gastroesophageal regurgitation during these various surgical procedures under general anesthesia.

Investigators include the patients who will receive scheduled surgery under SAD-based general anesthesia and aged >= 20 will be enrolled. All subjects provide basic demographic data and fill in standard symptom questionnaire for evaluation of baseline severity of gastroesophageal reflux and other associated gastrointestinal and sleep symptoms. Supraglottic airway device with i-gel will be inserted to establish airway, and the gastric content will be suctioned out through the esophageal vent of i-gel. MII-pH catheter will be inserted though the esophageal vent of i-gel to detect and characterize gastroesophageal reflux events in the perioperative period. After removal of SAD, the patients were follow the saturation, sore throat or hoarseness in the postoperative care unit, as well as the possible complications.

Investigators will not only elucidate the clinical characteristics and risk factors in patients receiving elective surgeries, but also determine the severity of gastric regurgitation during the intraoperative period.

Investigators will correlate the reflux pattern, frequency, content and proximal extent of all reflux events and symptom correlation with clinical features in the intraoperative period. The study results could help us study more in the gastric regurgitation in perioperative period.

Conditions

The Episodes of Gastric Regurgitation

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Supraglottic airway device-based anesthesia

Investigators planned to enroll 200 cases who will receive scheduled surgery under supraglottic airway device-based general anesthesia.

the effect of surgical position

Intervention Type: OTHER

Investigators do not have intervention in the observation study. Investigators only use the MII-pH catheter to observe the episodes of gastric regurgitation in patients receiving supraglottic airway device under general anesthesia. Thus, investigators are going to observe the effect of surgical position change, body weight, surgical time. And investigators will have a control group, which patients undergo elective surgeries without surgical position change, no longer surgical time, and normal range of body weight.

Interventions

the effect of surgical position

Investigators do not have intervention in the observation study. Investigators only use the MII-pH catheter to observe the episodes of gastric regurgitation in patients receiving supraglottic airway device under general anesthesia. Thus, investigators are going to observe the effect of surgical position change, body weight, surgical time. And investigators will have a control group, which patients undergo elective surgeries without surgical position change, no longer surgical time, and normal range of body weight.

Intervention Type: OTHER

Other Intervention Names

the effect of body weight; The effect of surgical time; The standard elective surgery as control group

Eligibility Criteria

Inclusion Criteria

1. Patients who will receive scheduled surgery under SAD-based general anesthesia

2. Aged >= 20

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. prior nasal surgery or trauma

5. current use anticoagulant or antiplatelet agents

6. coagulopathy

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Shouzen Fan, MD,PhD

Role: CONTACT

shouzen@gmail.com

+886-972651601

Other Identifiers

201603012RIND

Identifier Type: -

Identifier Source: org_study_id