Clinical Trial: Prophylaxis for Aspiration of Gastric Contents.

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: "Effect of Orally Administered Two Successive Doses of PPIs and/ or H2RAs Without or With a Prokinetic Drug, on the Intragastric pH and Volume and Bile Refluxate in Adults Patients Undergoing Ele

Brief Summary: Effect of orally administered two equal and consecutive doses of proton pump inhibitors, omeprazole, lansoprazole, esomeprazole , rabeprazole and pantoprazole and Histamine 2 receptor antagonists cimetidine, ranitidine,famotidine,nizatidine and lafutidine without and with a prokinetic agents domperidone, metoclopramide and erythromycin on intragastric pH, volume and bile refluxate.

Detailed Summary:

(This description is for one drug and similar for other drugs) We repacked the placebo, lansoprazole 15 mg and lansoprazole 15 mg plus domperidone 10 mg in 180 envelopes (times two) and then two envelope in one envelope each for evening and morning of the same size, shape and color and their name were changed as drug one, drug two and drug three by a person who was not taking part in the study to the patients (single-blind) and investigators (double-blind) blinded of it. The group assign paper was sealed in another envelope that was opened to know which drug corresponds to either drug one or drug two or drug three after the statistical analysis(triple-blind).

On the preoperative anaesthesia visit, a day before surgery, the nature and purpose of the study was explained to each patient. We asked each patient to pick up on one envelop from the envelopes (randomization). Thus the patients were allocated to either Group C (control), Group L lansoprazole 15 mg or Group LD lansoprazole 15 mg with domperidone 10 mg randomly by sealed envelope method. Age, sex, ASA physical status, weight, height, BMI and the study drug given were recorded for each patient. All patients also received tablet diazepam 5 mg with study drugs. These drugs were given orally with 20 ml of drinking water at 8:00 p.m. in the evening day before surgery and 6:00 a.m. morning on the day of surgery. According to the hospital policy, all patients were fasted from 12:00 midnight. Upon arrival in the receiving area of the operating room. All patients were asked if they had been aware of any unusual feeling (side effect) after taking the study drug.

In the operating room, routine monitors were attached to the patients and turned on. After pre-oxygenation with 100% O2 by face mask using eight breaths vital capacity method, anaesthesia was induced with injection fent
Sponsor: King Saud University

Current Primary Outcome: pH of gastric contents [ Time Frame: Immediate after induction of general anaesthesia ]

pH was measured with pH meter. Unit whole digit with two decimal point for example, 4.24


Original Primary Outcome: Same as current

Current Secondary Outcome: volume of gastric contents [ Time Frame: Immediate after induction of general anesthesia. ]

Measured with graduated syringe. Units milliliters (ml)


Original Secondary Outcome: Same as current

Information By: King Saud University

Dates:
Date Received: February 28, 2016
Date Started: January 2012
Date Completion:
Last Updated: March 8, 2016
Last Verified: March 2016