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IRCT20170314033069N5 IRCT 2022-12-31 Rasht University of Medical Sciences The effect of aminophylline on the recovery time of hysterectomy patients under general anesthesia Investigating the effect of aminophylline on the recovery time of hysterectomy patients under general anesthesia; A randomized double-blind clinical trial 2023-01-20 anticipated 74 Complete https://irct.ir/trial/67658 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Patients will be assigned to two groups A, aminophylline and B control by a random sequence created in blocks of four by WinPepi software, which was created by a statistical consultant and will be performed by a technician who is not aware of the goals of the study, Blinding description: The drugs will be prepared in similar syringes by the anesthetic technician who is not aware of the goals of the study and will be provided to the anesthesia assistant. In this study, the anesthesiologist, the anesthesiology assistant who records the patient's information, and the patient are not able to recognize the received intervention, hence the study will be double-blind. In case of any complications, the anesthesiologist present in the operating room will be informed of the treatment groups to take the necessary actions. 3 Investigating the effect of aminophylline on the recovery time of patients after hysterectomy. Intervention 1: Intervention group: After uterus removal by the surgeon, patients in the intervention group will receive 3 milligrams per kilogram of intravenous aminophylline (manufactured by Caspian Tamin Pharmaceutical Company) diluted in 100 milliliters of normal saline. The infusion will last for 15 minutes. Intervention 2: Control group: After uterus removal by the surgeon, patients in the control group will receive 100 milliliters of normal saline. The infusion will last for 15 minutes. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Not decided yet
public Dr Gelareh Biazar
Anesthesiology Research Center, Alzahra Hospital, Namjoo Street, Rasht, Iran
Rasht Iran (Islamic Republic of) 4144654839 +98 13 3332 9524 gelarehbiazar1386@gmail.com Rasht University of Medical Sciences scientific Dr Gelareh Biazar
Anesthesiology Research Center, Alzahra Hospital, Namjoo Street, Rasht, Iran
Rasht Iran (Islamic Republic of) 4144654839 +98 13 3332 9524 gelarehbiazar1386@gmail.com Rasht University of Medical Sciences Iran (Islamic Republic of) American Society of Anesthesiologists (ASA) I,II Candidate for hysterectomy under general anesthesia in Alzahra hospital Women aged 30 to 70 30 years 70 years Female Hysterectomy due to malignancy Any history of allergy to aminophylline or drug components Any dysfunction of the liver, including liver cirrhosis, fatty liver, etc smokers People who have recently received or are taking cimetidine, ciprofloxacin, and macrolides such as erythromycin and clarithromycin History of any type of arrhythmia or neurological disorder such as epilepsy Patient dissatisfaction O74 Complications of anesthesia during labor and delivery Treatment - Surgery Placebo Intervention group: After uterus removal by the surgeon, patients in the intervention group will receive 3 milligrams per kilogram of intravenous aminophylline (manufactured by Caspian Tamin Pharmaceutical Company) diluted in 100 milliliters of normal saline. The infusion will last for 15 minutes. Control group: After uterus removal by the surgeon, patients in the control group will receive 100 milliliters of normal saline. The infusion will last for 15 minutes. Emergence from anesthesia. Timepoint: From the time of discontinuing administration of anesthetic drugs to the time of patient's eyes getting open after calling her/his name. Method of measurement: Time measurement. Extubation time. Timepoint: From the time of discontinuing administration of anesthetic drugs to the time of removing the endotracheal tube. Method of measurement: Time measurement. Recovery time. Timepoint: From the time of discontinuing administration of anesthetic drugs to the time of transferring the patient to the ward. Method of measurement: Time measurement. Mean arterial blood pressure (MAP). Timepoint: Before administration of aminophylline and normal saline and then every 5 minutes until transferring to recovery, then every 15 minutes during recovery. Method of measurement: Blood pressure measurement with mercury sphygmomanometer. Heart rate. Timepoint: Before administration of aminophylline and normal saline and then every 5 minutes until transferring to recovery, then every 15 minutes during recovery. Method of measurement: Heart rate monitor. Rasht University of Medical Sciences Approved 2022-12-07 Ethics committee of Guilan University of Medical Sciences Vice Chancellor for research, Shahid Siadati Avenue, Namjoo Street,Rasht Rasht Guilan Iran (Islamic Republic of)