Evaluation of the promethazine prescription effect on sedation, nausea reduction and quality of the upper Esophageal gastro Endoscopy

Determining the effect of promethazine prescription on sedation, reducing nausea and quality of upper esophageal and gastric endoscopy

A randomized clinical trial on 22 patients. Groups include intervention and control groups. Patients will be randomly allocated to the groups using simple randomization method with random number table.

Participants will be selected from patients of Urmia Imam Khomeini endoscopy ward and will be allocated randomly to the intervention and control groups. The intervention group will be given 30 cc of promethazine syrup in 100 cc of drinking water and the control group will be given 50 glucose dissolved in 100 cc of drinking water.

Inclusion criteria: age between 18 and 40 years, Systolic blood pressure greater than 90 and less than 130 mm Hg, peripheral blood saturation without oxygen more than 95%, no use of sleeping pills, respiratory rate between 12 to 18 times per minute، do not take any drug other than antacids ،willingness to participate in the study. Exclusion criteria: Presence of diabetes, hypertension, thyroid disease, heart disease, liver disease such as cirrhosis and hepatitis, chronic or acute lung disease, Rheumatologic disease, neurological disease and pregnancy.

In the intervention group, 30 cc of promethazine syrup (1mg /cc ) in 100 cc of drinking water made by Emad Darman Pars Pharmaceutical Company will be given to the patient one hour before endoscopy by someone other than the endoscopist. In the control group, 50 g of glucose dissolved in 100 cc of drinking water will be given to the patient one hour before endoscopy.

total procedure time, Patient cooperation , endoscopist satisfaction, patient satisfaction, duration of recovery , complications, patient anxiety, patient level of consciousness

Patients will be divided into intervention or control groups by the randomization method with a table of random numbers. First, patients will be given a code from 01 to 22. Then a number will be randomly selected from the table and will be continued from top to bottom in the table to complete the sample size. The duplicate number will be ignored and another number from the table will be checked. Numbers 01 to 11 and 11 to 22 will be assigned to the intervention group and control group, respectively.

The study will be double-blind. The patient and the endoscopist will be blind that which groups each patient belongs to. The amount, color, and even taste of promethazine and glucose syrup will be given equally to patients in both groups. In the intervention group, 30 cc of promethazine syrup is added into 70 cc of drinking water, one hour before the endoscopy will be given to the patient by someone other than the endoscopist. In the control group, 50 g of sugar is dissolved in 100 cc of drinking water. It will be given to the patients one hour before endoscopy after adding five cc of cherry juice (to match the color and taste of promethazine syrup).