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

General Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03672734
• Other study ID #: 328/2561(EC3)
• Status: Enrolling by invitation
• Start date: September 20, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: September 2018
• Source: Siriraj Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. completion date: December 31, 2019
• Est. primary completion date: September 20, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• ASA class 1-2,

• 18-65 years old,

• Laparoscopic surgery,

• BMI<30kg/sq.m.

Exclusion Criteria:

• Difficult inserted orogastric tube.

Related Conditions & MeSH terms

• General Anesthesia

Locations

Country	Name	City	State
Thailand	Waerunee Boayam	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Siriraj Hospital

Country where clinical trial is conducted

Thailand, 

References & Publications (16)

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. — View Citation

Brocks K, Jensen JS, Schmidt JF, Jørgensen BC. Gastric contents and pH after oral premedication. Acta Anaesthesiol Scand. 1987 Jul;31(5):448-9. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Haavik PE, Søreide E, Hofstad B, Steen PA. Does preoperative anxiety influence gastric fluid volume and acidity? Anesth Analg. 1992 Jul;75(1):91-4. — View Citation

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. — View Citation

Noakes TD, Rehrer NJ, Maughan RJ. The importance of volume in regulating gastric emptying. Med Sci Sports Exerc. 1991 Mar;23(3):307-13. Review. — View Citation

Ong BY, Palahniuk RJ, Cumming M. Gastric volume and pH in out-patients. Can Anaesth Soc J. 1978 Jan;25(1):36-9. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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 children†. Br J Anaesth. 2015 Mar;114(3):477-82. doi: 10.1093/bja/aeu399. Epub 2014 Dec 13. — View Citation

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. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Volume of Gastric Content	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