]>
IRCT20200825048515N73 IRCT 2024-02-16 Esfahan University of Medical Sciences Comparison of the effects of two different doses of dexmedomidine and propofol in sedation during ovarian surgery Comparing the effect of two different doses of dexmedetomidine and propofol in sedation during surgery; Hemodynamic changes and postoperative complications in patients undergoing ovarian puncture surgery 2024-03-20 anticipated 96 Complete https://irct.ir/trial/75509 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, 96 eligible patients are randomly selected. For this, the letter A is written on 32 sheets, the letter B is written on 32 sheets, the letter C is written on 32 sheets and each of them is placed in an envelope. Each patient is then asked to choose one of the envelopes. Depending on the selected envelope, the patient is assigned to one of three groups, Blinding description: In order to achieve the triple-blind study, different doses of dexmedomidine and propofol will be prepared daily by the operating room nurse (without the researcher's awareness) and placed in the bag and will be labeled A, B, and C. And is given daily to the anesthesiologist (researcher). Therefore, the patient, the Investigator, the person recording the clinical and basic information of the patients as well as the statistical analyst will not be aware of the type of intervention. 3 Ovarian puncture surgery. Intervention 1: Control group: in this group, propofol induction of anesthesia 50 μg/kg per minute is prescribed. Intervention 2: First intervention group: In this group, dexmedetomidine bolus dose of 0.5 μg/kg is prescribed for induction of anesthesia, and dexmedetomidine dose of 0.5 μg/kg per minute is prescribed for anesthesia maintenance. Intervention 3: The second intervention group: In this group, a bolus dose of dexmedetomidine 1 μg/kg is prescribed for induction of anesthesia, and a dose of dexmedetomidine 1 μg/kg per minute is prescribed for anesthesia maintenance. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Mohammadreza Habibzadeh
Anesthesiology Department, Al-Zahra Hospita, Sefeh Blvd., Tohid Street
Isfahan Iran (Islamic Republic of) 8174675731 +98 31 3620 2020 M.habibzadeh@med.mui.ac.ir Esfahan University of Medical Sciences scientific Mohammadreza Habibzadeh
Anesthesiology Department, Al-Zahra Hospita, Sefeh Blvd., Tohid Street
Isfahan Iran (Islamic Republic of) 8174675731 +98 31 3620 2020 M.habibzadeh@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Infertile women candidates for puncture operation with IVF/ICSI indication Age 25 to 43 years With ASA I or II Consent to enter the study 25 years 43 years Both Having an allergy to any drug used Having a history of diseases such as epilepsy and gastric reflux and a history of severe cardiovascular disease and the presence of atrial block or stroke Treatment - Drugs Treatment - Drugs Treatment - Surgery Control group: in this group, propofol induction of anesthesia 50 μg/kg per minute is prescribed. First intervention group: In this group, dexmedetomidine bolus dose of 0.5 μg/kg is prescribed for induction of anesthesia, and dexmedetomidine dose of 0.5 μg/kg per minute is prescribed for anesthesia maintenance. The second intervention group: In this group, a bolus dose of dexmedetomidine 1 μg/kg is prescribed for induction of anesthesia, and a dose of dexmedetomidine 1 μg/kg per minute is prescribed for anesthesia maintenance. Sedation. Timepoint: Before the intervention and then 5, 10, 15 and 30 minutes after the intervention and then every 15 minutes during recovery until discharge. Method of measurement: Richmond sedation score scale (RASS) as a score of +4 to -5. Hear rate. Timepoint: Before the intervention and then 5, 10, 15 and 30 minutes after the intervention and then every 15 minutes during recovery until discharge. Method of measurement: Monitoring device. Diastolic blood pressure. Timepoint: Before the intervention and then 5, 10, 15 and 30 minutes after the intervention and then every 15 minutes during recovery until discharge. Method of measurement: Monitoring device. Systolic blood pressure. Timepoint: Before the intervention and then 5, 10, 15 and 30 minutes after the intervention and then every 15 minutes during recovery until discharge. Method of measurement: Monitoring device. Isfahan University of Medical Sciences Approved 2023-12-27 Ethics committee of Isfahan University of Medical Sciences Street address Isfahan University of Medical Sciences, Hezar Jarib Ave., Azadi Sq Isfahan Isfehan Iran (Islamic Republic of)