Comparison of the Effect of Pethidine and Dexmedetomidine on Relieving Shivering after Cesarean Section under Spinal Anesthesia in Patients that Received Misoprostol

Comparison of the Effect of Pethidine and Dexmedetomidine on Relieving Shivering after Cesarean Section under Spinal Anesthesia in Patients that Received Misoprostol

Clinical trial, parallel groups, double-blind, randomized, phase 3 on 80 patients. In order to randomize, the block randomization method will be used.

Patients who are candidates for general anesthesia at Firouzgar and Rasoul Akram Hospitals in Tehran will be included in the study. Patients will be randomly divided into 3 groups based on blocks of 3. Patients, specialist Anesthesi and data analyst will be blinded.

Inclusion criteria: pregnant women in the age range of 18 to 45 years with with normal health or mild systemic disease, and candidates for cesarean section who underwent spinal anesthesia and received mesoprostol and experienced chills (grade 3 or 4 according to Crossley and Mahajan scale). Inclusion criteria: lack of consent to spinal anesthesia by the patient, history of spinal surgery, having any contraindications for spinal anesthesia, emergency cesarean delivery, weight less than 60 kg or more than 120 kg, known hypersensitivity to dexmedetomidine or pethidine, heart disease , kidney or liver that requires follow-up or medication, pre-eclampsia, general anesthesia, combined spinal-epidural anesthesia.

Intervention group1: 0.3 ml of dexmedetomidine with a concentration of 100 μg/ml (manufacturer: Exir Pharmaceutical Company) by the specialist Anesthesia will be injected intravenously. Intervention group2: 0.5 ml of pethidine with a concentration of 50 mg/ml (manufacturer: Exir Pharmaceutical Company) by The anesthesiologist will inject intravenously.

Shivering

Patients will be randomly divided into 2 groups. The randomization tool will randomize the table of numbers. Block randomization method will be used for randomization. Block randomization is for the purpose of making sure that exactly equal number of participants enter the study groups. The advantages of block randomization are that the balance of the number of participants in each group is guaranteed. For this purpose, 8 blocks will be formed and in each block 4 people from intervention group and 4 people will be placed in the control group. A total of 10 blocks will be considered to reach the sample size. Blocks contain numbers, numbers represent study groups. Their order will be determined by the statistician from the beginning. In order to hide the random allocation, opaque envelopes sealed with a random sequence will be used. In this method, each of the generated random sequences will be recorded on a card and the cards will be placed in the envelopes in order. became. In order to maintain a random sequence, the outer surface of the envelopes is numbered in the same order. Finally, the lid of the letter envelopes is glued and placed in a box. At the time of registration of participants, based on the order of entry of qualified participants into the study, one of the envelopes will be opened in order and the assigned group of that participant will be revealed.

Patients will be unaware and blind of the type of drug injected. Patients will be aware that they will be randomly assigned to one of the two study groups, but will not know which method will be offered in that group. Patients will be assigned to one of two groups using a random number table. The anesthesiologist who injects the drug will not know which drug will be used for each patient. The person in charge of data collection, the analyst and the outcome evaluator will collect and analyze the information based on groups 1 and 2 and will not know the type of drug injected in the groups and will be kept blind.