Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02703896 |
| Other study ID # |
06-546 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
Phase 4
|
| First received |
February 28, 2016 |
| Last updated |
March 8, 2016 |
| Start date |
January 2012 |
| Est. completion date |
December 2015 |
Study information
| Verified date |
March 2016 |
| Source |
King Saud University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
Saudi Arabia ':'King Saud University |
| Study type |
Interventional
|
Clinical Trial 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.
Description:
(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 fentanyl 1-2 mcg/kg, propofol 2-3 mg/kg and
rocuronium 0.6-0.9 mg/kg. Lungs were ventilated taking care not to inflate the stomach.
Maintaining cricoid pressure trachea was intubated with cuffed endotracheal tube. Placement
and position was confirmed with EtCO2 monitor and then secured properly. After establishing
stable anaesthesia, an endotracheal tube sized 8.5 internal diameter was passed via oral
route in the esophagus with anterior displacement of larynx. A predetermined length marked
with adhesive tape (xiphoid process to ear lobule- fro ear lobule to nasal tip) of stomach
tube sized 18 F was passed through the esophageally placed endotracheal tube. Placement of
this tube within the stomach was verified with auscultation over the epigastrium during
insufflation of 10-15 ml of air. Gastric contents were gently aspirated manually with 60 ml
syringe by an investigator who was blind of group assignment. Applying manual pressure over
the epigastrium while the patient was in supine and then left and right lateral positions,
gastric tube was then manipulated to ensure maximum emptying of gastric contents. The
stomach tube was then removed followed by esophageally placed endotracheal tube. Any problem
encountered during inserting or removing the oro-esophageally placed endotracheal tube or
gastric tube was also recorded. The volume of gastric contents was measured with graduated
syringe and pH using pH meter. The pH meter was calibrated using standard buffers at pH
values of 4, 7 and 9.20. This pH meter has a precision of 0.01 units over the entire pH
range. A minimum of one-millimeter volume of gastric contents was sufficient for pH
determination with pH meter. In case of very little amount of gastric contents, we cut the
stomach tube and aspirated gastric material with disposable plastic pipette. Samples less
than one-millimeter were considered as no gastric contents because a minimum of one-
millimeter of gastric contents was sufficient for pH- metry. Using bile salts as marker for
bile, we applied qualitative Hay's sulphur test for the presence of bile salts. A minimum
volume of one millimeter of gastric contents was adequate to perform Hay's sulphur test. In
this test finely powered sulphur is sprinkled on the surface of cool (17 OC or below)
liquid. If bile salts are present sulphur sinks down, sooner or later, in accordance with
their percentage. If bile salts are present in from 1:5,000 (0.02%or 200 mcg/ml to 1:10,000
(0.01% or 100 mcg/ml) sulphur at once begins to sink and all precipitated in two or three
minutes; even in dilution of 1:120,000 (0.0008% or 8.33 mcg/ml precipitation occurs. On the
other hand, if sulphur remains floating on the surface, bile salts are absent.
Anaesthesia was maintained with air, O2 and sevoflorane. Patients also received incremental
doses of fentanyl and rocuronium as required. At the end of surgery, injection atropine and
neostigmine were given to antagonize the residual effect of rocuronium. All patients were
extubated in lateral position and then transferred to recovery room.
Time since premedication T1 (time from evening dose till aspiration of gastric contents) and
Time since premedicationT2 (time from morning dose till aspiration of gastric contents), pH,
volume of gastric contents and results of Hay's sulphur test were also recorded for all
patients.
Statistical test were performed using GraphPad Software, Inc., San Diego, United States and
results are expressed as absolute values or mean ± standard deviation SD (SEM). Statistical
analysis between the groups were carried out using analysis of variance (ANOVA) for age,
BMI, time since premedication T1, time since NPO and T2 , pH and volume. Chi square test was
applied for sex, ASA physical status, Hay's test and risk of aspiration according to
criteria defined (pH ≤ 2.5 and volume ≥ 0.4ml/kg or 25 ml. Post hoc tests with Bonferrni
correction applied where p-value significant(p <0,05). A p-value of less than 0.05 was
considered statistically significant. Power analysis revealed that the sample size (n= 30)
in each group was of the study was sufficient to detect a difference of 0.7 among the groups
in gastric pH and volume at a significant level of 0.05 (=α 0 with a power of 0.85.
