Studying effect of Dexmedetomidine on postoprative Nausea & Vomiting(PONV)In Laparascopic Cholecystectomy in Addict patient

effect of dexmedetomidine(DEX) on postoperative nausea & vomiting(ponv) in laparoscopic cholecystectomy in addicted patients

Clinical trial with control group, parallel groups, double-blind, randomized, phase 3 on 100 patients, patients with aspect ratio (1:1), receiving DEX or placebo, according to the random number generation table

100 addicted patients, laparoscopic cholecystectomy ,Shohadaye Tajrish Hosp, written consent, by random block division into 2 groups of 50 people (intervention and placebo group), DEX and placebo with shape, color, size and same packaging, A&B coding before use (not by researcher),10 minutes after induction until the end , intervention group under infusion of of DEX and placebo group under infusion of normal saline, recording information during and after operation by an experienced person (unfamiliar with the control & intervention groups), transfer to the recovery, observation and interview by trained personnel to evaluate variables (nausea,retching, vomiting, regurgitation), recording data in different minutes, making 2 files (intervention & control groups) for statistical use

Inclusion : Addicted ,age 20 - 60 , ASA 1& 2, SBP before & during operation between 90 - 140 mm Hg Exclusion : Laparotomy, surgery more than 4 hours, severe bleeding, ASA 3, motion sickness ,PONV, heart or GI disease, nausea & vomiting before surgery, drug withdrawal before surgery, anti-emetic drug use

10 minutes after induction until the end, intervention group will undergo infusion of 1 microgram per minute DEX per kilogram of weight, placebo group will undergo N/S infusion

degrees of ponv (nausea,retcging,regurgitation ,vomiting) for intervention and control groups, main variable ponv, its degrees ,hemodynamic and demographic variables are secondary.

The sampling is random, and the allocation is done according to the table of random numbers in two groups and the ratio of one to one in the intervention and control groups is done according to the sample size formula. Receiving dexmedetomidine or placebo are assigned based on the random number generation table. Patients are divided into two groups of 50 and each patient is randomly assigned a number. The control group includes numbers 1 to 50 and the intervention group includes numbers 51 to 100.

100 patients with drug addiction (according to the definition), candidates for laparoscopic cholecystectomy in Shohada Tajrish Hospital, who meet the entry criteria for the study, are informed by the trained personnel about the implementation and objectives of the study, and if they wish to participate in the study A written consent form is obtained from them and then each patient is classified according to the classification made using the random block division method and placed in the group receiving dexmethomidine (intervention group) or the placebo group (control group) means 2 groups of 50 people. It should be noted that if a patient is removed from the study for any reason, a person who has no knowledge of the intervention group and the control group will be randomly replaced with a new patient who meets the criteria for entering the project. With this process, the number of evaluated patients may exceed 100. Before the operation, each patient is interviewed by an anesthesiologist and demographic, hemodynamic, history and entry criteria are collected and the information is recorded in the relevant form. Dexmethomidine and placebo drugs are prepared with the same shape, color, size and packaging and are coded as A&B before injection by a person other than the researcher. The group under intervention with dexmethomidine drug 10 minutes after induction under dexmethomidine infusion 1 mcg/kg /min is placed and this continues until the end of the operation. And the placebo group also receives normal saline infusion 10 minutes after induction until the end of the procedure. The information is recorded from the time of arrival until 120 minutes later by the medical evaluator who does not know the type of patient group. After collecting all the information of the patients, this information will compiled into two files (the intervention group with dexmedetomidine and the control group with placebo) and will be used statistically.

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