NCT03672734

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 31, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 14, 2018

Completed
6 days until next milestone

Study Start

First participant enrolled

September 20, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

April 4, 2019

Status Verified

September 1, 2018

Enrollment Period

1 year

First QC Date

August 31, 2018

Last Update Submit

April 2, 2019

Conditions

Keywords

pH gastric contentslaparoscopic surgerypH stomachvolume gastric content

Outcome Measures

Primary Outcomes (1)

  • pH of Gastric Contents

    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 Outcomes (1)

  • Volume of Gastric Content

    6 hours

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients underwent gynecologic laparoscopic surgery.

You may qualify if:

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

You may not qualify if:

  • Difficult inserted orogastric tube.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Waerunee Boayam

Bangkok, 10700, Thailand

Location

Related Publications (16)

  • Perlas A, Chan VW, Lupu CM, Mitsakakis N, Hanbidge A. Ultrasound assessment of gastric content and volume. Anesthesiology. 2009 Jul;111(1):82-9. doi: 10.1097/ALN.0b013e3181a97250.

    PMID: 19512861BACKGROUND
  • Ouanes JP, Bicket MC, Togioka B, Tomas VG, Wu CL, Murphy JD. The role of perioperative chewing gum on gastric fluid volume and gastric pH: a meta-analysis. J Clin Anesth. 2015 Mar;27(2):146-52. doi: 10.1016/j.jclinane.2014.07.005. Epub 2014 Nov 28.

    PMID: 25442242BACKGROUND
  • Schmidt AR, Buehler P, Seglias L, Stark T, Brotschi B, Renner T, Sabandal C, Klaghofer R, Weiss M, Schmitz A. Gastric pH and residual volume after 1 and 2 h fasting time for clear fluids in childrendagger. Br J Anaesth. 2015 Mar;114(3):477-82. doi: 10.1093/bja/aeu399. Epub 2014 Dec 13.

    PMID: 25501720BACKGROUND
  • Phillips S, Liang SS, Formaz-Preston A, Stewart PA. High-risk residual gastric content in fasted patients undergoing gastrointestinal endoscopy: a prospective cohort study of prevalence and predictors. Anaesth Intensive Care. 2015 Nov;43(6):728-33. doi: 10.1177/0310057X1504300610.

    PMID: 26603797BACKGROUND
  • Splinter WM. From the Journal archives: gastric fluid volume and pH in elective patients following unrestricted oral fluid until three hours before surgery. Can J Anaesth. 2014 Dec;61(12):1126-9. doi: 10.1007/s12630-014-0220-z. Epub 2014 Aug 15. No abstract available.

    PMID: 25125250BACKGROUND
  • Goudra BG, Singh PM, Carlin A, Manjunath AK, Reihmer J, Gouda GB, Ginsberg GG. Effect of Gum Chewing on the Volume and pH of Gastric Contents: A Prospective Randomized Study. Dig Dis Sci. 2015 Apr;60(4):979-83. doi: 10.1007/s10620-014-3404-z. Epub 2014 Nov 2.

    PMID: 25362513BACKGROUND
  • Ong BY, Palahniuk RJ, Cumming M. Gastric volume and pH in out-patients. Can Anaesth Soc J. 1978 Jan;25(1):36-9. doi: 10.1007/BF03006781.

    PMID: 23891BACKGROUND
  • Gouda BB, Lydon AM, Badhe A, Shorten GD. A comparison of the effects of ranitidine and omeprazole on volume and pH of gastric contents in elective surgical patients. Eur J Anaesthesiol. 2004 Apr;21(4):260-4. doi: 10.1017/s0265021504004028.

    PMID: 15109187BACKGROUND
  • Gombar S, Kiran S, Gupta M, Gombar K, Chhabra B. Preanaesthetic oral ranitidine, omeprazole and metoclopramide for modifying gastric fluid volume and pH. Can J Anaesth. 1994 Sep;41(9):879-80. doi: 10.1007/BF03011614. No abstract available.

    PMID: 7955016BACKGROUND
  • Boulay K, Blanloeil Y, Bourveau M, Geay G, Malinovsky JM. Effects of oral ranitidine, famotidine and omeprazole on gastric volume and pH at induction and recovery from general anaesthesia. Br J Anaesth. 1994 Oct;73(4):475-8. doi: 10.1093/bja/73.4.475.

    PMID: 7999487BACKGROUND
  • Chang KK, Jawan B, Fung ST, Lee JH. Effect of preoperative fasting time on gastric volume and pH. Ma Zui Xue Za Zhi. 1989 Jun;27(2):149-52.

    PMID: 2796624BACKGROUND
  • Haavik PE, Soreide E, Hofstad B, Steen PA. Does preoperative anxiety influence gastric fluid volume and acidity? Anesth Analg. 1992 Jul;75(1):91-4. doi: 10.1213/00000539-199207000-00017.

    PMID: 1535490BACKGROUND
  • Maltby JR, Lewis P, Martin A, Sutheriand LR. Gastric fluid volume and pH in elective patients following unrestricted oral fluid until three hours before surgery. Can J Anaesth. 1991 May;38(4 Pt 1):425-9. doi: 10.1007/BF03007577.

    PMID: 2065409BACKGROUND
  • Noakes TD, Rehrer NJ, Maughan RJ. The importance of volume in regulating gastric emptying. Med Sci Sports Exerc. 1991 Mar;23(3):307-13.

    PMID: 1875801BACKGROUND
  • Goetze O, Treier R, Fox M, Steingoetter A, Fried M, Boesiger P, Schwizer W. The effect of gastric secretion on gastric physiology and emptying in the fasted and fed state assessed by magnetic resonance imaging. Neurogastroenterol Motil. 2009 Jul;21(7):725-e42. doi: 10.1111/j.1365-2982.2009.01293.x. Epub 2009 Apr 1.

    PMID: 19344341BACKGROUND
  • Brocks K, Jensen JS, Schmidt JF, Jorgensen BC. Gastric contents and pH after oral premedication. Acta Anaesthesiol Scand. 1987 Jul;31(5):448-9. doi: 10.1111/j.1399-6576.1987.tb02600.x.

    PMID: 3630589BACKGROUND

Study Officials

  • Warunede Buayam, B.NS

    Department of Anesthesiology, Faculty of Medicine, Siriraj hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department of Anesthesiology, Faculty of Medicine Siriraj Hospital, Mahidol university

Study Record Dates

First Submitted

August 31, 2018

First Posted

September 14, 2018

Study Start

September 20, 2018

Primary Completion

September 20, 2019

Study Completion

December 31, 2019

Last Updated

April 4, 2019

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share

Locations