Assessment of Oxycodone and Mebeverin mixed-effects on colonoscopy quality in patients referring to Urmia Imam Khomeini hospital

Determining the combined effect of oxycodone and Mebeverine on colonoscopy quality in patients referred to Imam Khomeini Hospital

Clinical trial with control group, with parallel groups, double-blind, randomized by random number table, phase three on 125 patients.

125 people referring to the colonoscopy ward of Imam Khomeini Educational and Medical Center in Urmia, if they have inclusion criteria and do not have exclusion criteria. after the randomization by the table of lucky numbers and blinding so that if the number is out between 1 to 62 The patient will be in the intervention group and will receive the drug (oxycodone and Mebeverine) and if the number is between 63 to 125 will be in the control group and will receive the placebo (vitamin B6 tablets and starch capsules) one hour before colonoscopy.

Anyone over the age of 18 who is suspected of having intestinal polyps, unexplained gastrointestinal bleeding, and intestinal disease will undergo a colonoscopy with the inclusion criteria of do not take antispasmodics drugs, complete mental health for informed consent, insensitivity to oxycodone and Mebeverine and no history of abdominal surgery. Non-entry conditions: History of allergy to any type of drug and irritable bowel syndrome.

In the intervention group, one oxycodone tablet and two Mebeverine capsules will be given to the patient one hour before colonoscopy by someone other than the endoscopist. In the control group, a vitamin B6 tablet will be given to the patient one hour before colonoscopy along with two starch-containing capsules.

Total procedure time, pain, time to reach the cecum

Randomization method is simple randomization. the researcher will divide patients by using table of random numbers. First, each patient will be assigned a three-digit code according to the date and time of the clinic visit. The first patient will have code 001 and the last patient will have code 125. Then in the table of random numbers without looking, a location will be randomly selected. The first two digits will be examined. If the number is less than or equal to 125, it will be selected, otherwise we will continue moving in the direction of the line and other numbers will be checked. If it is a duplicate number, it will be ignored and another number from the table will be checked. We continue this process until 62 codes are selected. The first 62 codes will be for patients in the intervention group (patients who will receive drugs) and the remaining 63 codes will be for the control group (patients who will receive placebo). Thus, patients are randomly divided into two groups.

The study will be two-way blind. The patient and the endoscopist will be unaware that the patient belongs to the case or control group. Pills and capsules in the same shape, size and color will be given to patients in both groups. In the intervention group, one oxycodone tablet, which is small and white, and two Mebeverine capsules, which are white, will be given to the patient one hour before colonoscopy by someone other than the endoscopist. In the control group, a vitamin B6 tablet, which is similar in shape, color and size to oxycodone and is completely safe, will be given to the patient one hour before colonoscopy, along with two starch-containing capsules that resemble Mebeverine capsules.