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IRCT20210406050864N1 IRCT 2021-11-07 Shahid Beheshti University of Medical Sciences The effect of intravenous metoclopramide on gastric emptying ندارد Evaluation of the effect of intravenous metoclopramide on gastric emptying in drug-using patients based on ultrasound criteria 2021-09-18 anticipated 135 Complete https://irct.ir/trial/57465 interventional Randomization: Not randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Blinding description: In this study, participants and the clinical caregiver who is the assistant in charge of the patient will be fully aware of the type of prescription. But the researcher himself, as well as the outcome assessor and data analyst, will be unaware of prescribing to the groups. 2-3 Effect of methoclopramide on gastric motility. Intervention 1: Intervention group: will include patients taking opium with a BMI less than 35. Who have consumed solid food in the last 8 hours or consumed clear liquids in the last 2 hours. After obtaining full consent and explanations on how to implement the plan, these patients will be included in the study and will be monitored and recorded at baseline values. These patients undergo ultrasound in both supine and right lateral position (RLP). After recording the measurements, 10 mg (2 cc) of metoclopramide is administered intravenously to patients. The ultrasound is then repeated 30 minutes later and these measurements will be recorded again. Ultrasound is used to qualitatively examine the material and contents of the stomach (liquid or solid). And antral-gastric grade are classified into three grades: zero, one and two: GRADE 0=absence of fluid GRADE 1 = fluid in RLP position GRAD 2=fluid in both supine and RLP position Quantitative examination will be in the form of Antral cross-sectional area (ACS) and Antral volume measurements. CSA will be calculated by measuring the vertical thickness in the two longitudinal (d1) and anterior-posterior planes (from serosa to serosa) (d2) and using the formula CSA = 3.14 (d1 * d2) 4%. This mathematical model is used to calculate the volume of stomach contents and determine the volume. VOLUME = 27 + (14.6 × RL CSA) _ (1.28 × age). Intervention 2: Control group: will include non-opium user patients with a BMI less than 35. Who have consumed solid food in the last 8 hours or consumed clear liquids in the last 2 hours. And all the interventions performed for intervention group 1 will be performed in the control group. Intervention 3: Control group 2: will include non-opium user patients with a BMI less than 35. Have consumed solid food in the last 8 hours or consumed clear liquids in the last 2 hours. Have consumed solid food in the last 8 hours or consumed clear liquids in the last 2 hours. All interventions in this group will be similar to the intervention group, but instead of administering metoclopramide, 2 ml of distilled water will be injected intravenously (placebo) for these patients. No - There is not a plan to make this available Justification or reason for not sharing IPD is Disagreement of some study participants with sharing of their information
public Mohamad javad Yazdipoor
Madani St
Tehran Iran (Islamic Republic of) 1617763141 +98 21 7443 2380 Mjyazdipooor@gmail.com Shahid Beheshti University of Medical Sciences scientific Mohamad javad Yazdipoor
Madani St
Tehran Iran (Islamic Republic of) 1617763141 98 73432380 Mjyazdipooor@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) All patients referred to the emergency department between the age of 16 and 80years All patients referred to the emergency department with BMI less than 35 All patients referred to the emergency department with history of opium use All patients who had consumed solid food in the past 8 hours or liquids in the previous 2 hours in the intervention group 16 years 80 years Both Patients who are unable to have an ultrasound for any reason Patients with a history of diabetes Patients with a history of gastrointestinal surgery Patients with suspected gastrointestinal obstruction Patients taking medication that affects gastrointestinal motility Patients with a history of inflammatory bowel disease Patients with a history of irritable bowel disease Treatment - Drugs Treatment - Drugs Placebo Intervention group: will include patients taking opium with a BMI less than 35. Who have consumed solid food in the last 8 hours or consumed clear liquids in the last 2 hours. After obtaining full consent and explanations on how to implement the plan, these patients will be included in the study and will be monitored and recorded at baseline values. These patients undergo ultrasound in both supine and right lateral position (RLP). After recording the measurements, 10 mg (2 cc) of metoclopramide is administered intravenously to patients. The ultrasound is then repeated 30 minutes later and these measurements will be recorded again. Ultrasound is used to qualitatively examine the material and contents of the stomach (liquid or solid). And antral-gastric grade are classified into three grades: zero, one and two: GRADE 0=absence of fluid GRADE 1 = fluid in RLP position GRAD 2=fluid in both supine and RLP position Quantitative examination will be in the form of Antral cross-sectional area (ACS) and Antral volume measurements. CSA will be calculated by measuring the vertical thickness in the two longitudinal (d1) and anterior-posterior planes (from serosa to serosa) (d2) and using the formula CSA = 3.14 (d1 * d2) 4%. This mathematical model is used to calculate the volume of stomach contents and determine the volume. VOLUME = 27 + (14.6 × RL CSA) _ (1.28 × age) Control group: will include non-opium user patients with a BMI less than 35. Who have consumed solid food in the last 8 hours or consumed clear liquids in the last 2 hours. And all the interventions performed for intervention group 1 will be performed in the control group. Control group 2: will include non-opium user patients with a BMI less than 35. Have consumed solid food in the last 8 hours or consumed clear liquids in the last 2 hours. Have consumed solid food in the last 8 hours or consumed clear liquids in the last 2 hours. All interventions in this group will be similar to the intervention group, but instead of administering metoclopramide, 2 ml of distilled water will be injected intravenously (placebo) for these patients. Gastric emptying. Timepoint: 30min. Method of measurement: sonographic criteria. Shahid Beheshti University of Medical Sciences Approved 2020-06-30 Ethics comitte of shahid beheshti university of medical science Yaman Street tehran Tehran Iran (Islamic Republic of)