Evaluation of the prophylactic effect of dexamethasone and droperidol in comparison with dexamethasone and ginger on nausea and vomiting in patients undergoing laparoscopic cholecystectomy

Evaluation of the prophylactic effect of dexamethasone and droperidol in comparison with dexamethasone and ginger on nausea and vomiting in patients undergoing laparoscopic cholecystectomy

Clinical trial, with two intervention and control groups, double-blind, with a sample size of 152, using the block randomization method with blocks of size 8.

This study will be conducted in Valiasr Hospital of Arak and on patients who will be candidates for cholecystectomy. The plan will be implemented in a double-blind manner. In this study, the patients do not know about the medicine received. To comply with the blinding, the medicines are prepared by the anesthesiologist in the same syringes and labels 1 and 2 will be placed on them, and then they will be given to the anesthesiologist for injection who won't know the intervention on each patient. Also the flour and ginger capsules will be prepared in the same way under the supervision of the anesthesiologist (in charge of the project) and will be given to the patients by the intern in charge of the project who is not aware of the groups.

Inclusion criteria: patients who are candidates for elective laparoscopic cholecystectomy in Amirul Mominin and Valiasr Arak hospitals, who are under general anesthesia, age 65-18 years, ASA anesthesia class I, II, surgery duration between 60-150 minutes. Non-inclusion criteria: sensitivity to droperidol and ginger,

Intervention: Dexamethasone 8 mg intravenously + droperidol 75 micrograms/kg intravenously + 4 capsules of flour. Control: Dexamethasone 8 mg intravenously + 4 oral ginger capsules + syringe containing distilled water

Nausea, vomiting, chills

To allocate the samples, the block randomization method with blocks of size 8 will be used. In this way, by using the software to generate random numbers using the block method and the randomization sequence, it will be produced according to the required sample size for the two groups. The two letters A and B can be arranged together in a block of size 8, and then a block is randomly selected from among the blocks, and the arrangement pattern in that block will be used to allocate the participants. Then this block in The original container will be placed and another block will be selected again. All these works will be done with a software called sealed envelope.

In order to comply with blinding, firstly, the patients do not know the type of drug received, and after informed consent, they will enter the plan without knowing the type of drug received. In the droperidol group, the same capsule as the ginger capsule is used, in which flour is placed and will be given to the patient, and in the ginger group, a syringe identical to the droperidol syringe containing distilled water will be used. In order to comply with the blinding, the drugs will be prepared in advance by the anesthesiologist (project guide) in syringes of the same shape and labels 1 and 2 will be placed on them, and then they will be given to the anesthesiologist of the project for injection. The study does not know will be placed. Also, the flour and ginger capsules are prepared in the same way under the supervision of the anesthesiologist in charge of the project (supervisor) and will be given to the patients by the intern in charge of the project who does not know about the groups, so the project will be implemented in a double-blind manner. After the surgery, the project questions will be completed by the intern responsible for the project (he is not aware of the groups).