Volume and pH of Gastric Contents in Patients Undergoing Gynecologic Laparoscopic Surgery During Emergence From General Anesthesia

April 2, 2019 updated by: Warunee Boayam, Siriraj Hospital

Observed Volume and pH of Gastric Contents in Patients Undergoing Gynecologic Laparoscopic Surgery During Emergence From General Anesthesia

Complications during general anesthesia,induction 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, opioid.This can cause decrease consciousness, delayed gastric emptying time. Incidence of pulmonary aspiration was 1 : 900 - 1 : 10,000 of general of anesthesia (induction 20%, emergence 80%), Anesthesia Service in Siriraj Hospital (2017) 6: 25,000 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 (Mendelson's syndrome).

Gastric acid is a digestive fluid formed in the stomach and is composed of hydrochloric acid, potassium chloride, and sodium chloride.The highest concentration of gastric acid is 140-160 mEq/L. The pH of gastric acid is 1.5-3.5 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.

Study Overview

Status

Unknown

Conditions

Detailed Description

The study was approved from the Siriraj Institutional Review Board (Si-IRB), COA (Certificate of Analysis):Si437/2018 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 year,BMI<30kg/sq.m. 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 mcg/kg. or morphine 0.1-0.2 mg/kg., propofol 1.5-2.5 mg/kg.,nimbex 1-1.5 mg/kg or atracurium 0.6 mg/kg. 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 Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Bangkok, Thailand, 10700
        • Waerunee Boayam

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

All patients underwent gynecologic laparoscopic surgery.

Description

Inclusion Criteria:

  • ASA class 1-2,
  • 18-65 years old,
  • Laparoscopic surgery,
  • BMI<30kg/sq.m.

Exclusion Criteria:

  • Difficult inserted orogastric tube.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pH of Gastric Contents
Time Frame: 6 hours
After general anesthesia, the investigator will insert an orogastric tube to drain the all the gastric secretion until the end of surgery. The pH of the content will be measured at the end of the operation.
6 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Volume of Gastric Content
Time Frame: 6 hours
After general anesthesia, the investigator will insert an orogastric tube to drain the all the gastric secretion until the end of surgery. The volume of the content (mL.) will be measured at the end of the operation.
6 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Siriraj Hospital

Investigators

  • Study Director: Warunede Buayam, B.NS, Department of Anesthesiology, Faculty of Medicine, Siriraj Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 20, 2018

Primary Completion (ANTICIPATED)

September 20, 2019

Study Completion (ANTICIPATED)

December 31, 2019

Study Registration Dates

First Submitted

August 31, 2018

First Submitted That Met QC Criteria

September 13, 2018

First Posted (ACTUAL)

September 14, 2018

Study Record Updates

Last Update Posted (ACTUAL)

April 4, 2019

Last Update Submitted That Met QC Criteria

April 2, 2019

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 328/2561(EC3)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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