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IRCT20201116049410N2 IRCT 2026-07-02 Esfahan University of Medical Sciences Comparing the effect of adding dexmedetomidine to propofol or isoflurane in deep vitrectomy Comparison of Adding Dexmedetomidine to Propofol versus Isoflurane on Hemodynamic Stability, Depth of Anesthesia, and postoperative Outcomes in Pars Plana Vitrectomy 2026-06-22 anticipated 94 Recruiting https://irct.ir/trial/90999 interventional Randomization: Not randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Blinding description: In this study, patients will be randomly assigned to the intervention groups. Due to the difference in the nature of the drugs used (propofol infusion versus isoflurane inhalation anesthesia), the anesthesiologist responsible for implementing the intervention will be aware of the type of treatment assigned and blinding is not possible.However, patients will not be aware of the type of maintenance anesthetic regimen they will receive and will be blinded to the assigned group. Also, the assessor of postoperative outcomes (including assessment of pain, nausea and vomiting, shivering, recovery score, and other variables of interest) and the person responsible for data collection will be unaware of the group allocation of patients. The data will also be provided to the statistical analyst with group codes (A and B), so that he will not be aware of the type of intervention in each group. Therefore, blinding will be performed at the level of the patient, the assessor of outcomes, and the statistical analyst, and only the anesthesiologist performing the intervention will be aware of the group allocation. 2-3 **Cardiovascular Complications, Hemodynamic Changes, and Depth of Anesthesia in Patients Undergoing Pars Plana Vitrectomy Under General Anesthesia**. Intervention 1: Intervention group: ** Anesthesia will be maintained with a continuous **propofol infusion** at a rate of **4–12 mg/kg/h**, titrated to maintain a **Bispectral Index (BIS)** between **40 and 60**. In addition, **intravenous dexmedetomidine** will be administered as a loading dose of **1 μg/kg over 10 minutes** (**0.5 μg/kg** in patients at risk of bradycardia), followed by a continuous infusion at a rate of **0.2 μg/kg/h** until the end of surgery. Intervention 2: Intervention group: ** Following induction of anesthesia, anesthesia will be maintained with **1–2% isoflurane**, with the concentration titrated according to the depth of anesthesia to maintain a **Bispectral Index (BIS)** between **40 and 60**. The target **minimum alveolar concentration (MAC)** of isoflurane will be maintained between **0.8 and 1.2**. In addition, **intravenous dexmedetomidine** will be administered as a loading dose of **1 μg/kg over 10 minutes** (**0.5 μg/kg** in patients at risk of bradycardia), followed by a continuous infusion at a rate of **0.2 μg/kg/h** until the end of surgery. Yes - There is a plan to make this available What will be shared: Only data related to the effects of the study drugs on hemodynamic parameters and hemodynamic changes will be made publicly available. Access to the complete dataset containing potentially identifiable or sensitive information will be granted only upon reasonable request, following approval by the principal investigator and after verification of the requester's academic qualifications and the intended purpose of data use. When: **One year after publication of the study results.** To whom: **Researchers affiliated with academic and scientific institutions.** Conditions: The data will be made available to researchers affiliated with academic and scientific institutions for use in **comparative studies** and **systematic reviews**, upon reasonable request and in accordance with the study's data-sharing policy. Where to obtain: Nikoo Heydari / 09138986159 / Heidarynikoo@gmail.com How to obtain: Individuals requesting access to the data should contact the principal investigator using the designated communication channels, according to the type of information requested. A response to the request will be provided within **one month**. Comments:
public Seyed Taghi Hashemi
Department of Anesthesiology and Critical Care, Educational and Medical Center, Alzahra Hospital, Shohada-ye Soffeh Street, Isfahan, Iran.
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3620 1992 st_hashemi@med.mui.ac.ir Esfahan University of Medical Sciences scientific Seyed Taghi Hashemi
Department of Anesthesiology and Critical Care, Educational and Medical Center, Alzahra Hospital, Shohada-ye Soffeh Street, Isfahan, Iran.
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3620 1992 st_hashemi@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Patients between the ages of 18-70 years with ASA physical status class 1-3 patients who are candidates for deep vitrectomy under general anesthesia 18 years 70 years Both Patients with ASA physical status class 4 and above Known allergy or sensitivity to the drugs used in the study (dexmedetomidine, propofol, isoflurane, atracurium, fentanyl, etc.) Impaired ocular function that is independent of underlying ocular disease and affects intraocular pressure History of recent eye surgery (less than 3 months ago) in the same eye Having neurological or mental illnesses that interfere with cooperation with the treatment team Patients with mental or physical disabilities that prevent them from understanding the study steps or participating effectively. Having an addiction to opioid products Pregnancy or breastfeeding Emergency deep vitrectomy surgeries Z01.818 Encounter for other preprocedural examination Treatment - Drugs Treatment - Drugs Intervention group: ** Anesthesia will be maintained with a continuous **propofol infusion** at a rate of **4–12 mg/kg/h**, titrated to maintain a **Bispectral Index (BIS)** between **40 and 60**. In addition, **intravenous dexmedetomidine** will be administered as a loading dose of **1 μg/kg over 10 minutes** (**0.5 μg/kg** in patients at risk of bradycardia), followed by a continuous infusion at a rate of **0.2 μg/kg/h** until the end of surgery. Intervention group: ** Following induction of anesthesia, anesthesia will be maintained with **1–2% isoflurane**, with the concentration titrated according to the depth of anesthesia to maintain a **Bispectral Index (BIS)** between **40 and 60**. The target **minimum alveolar concentration (MAC)** of isoflurane will be maintained between **0.8 and 1.2**. In addition, **intravenous dexmedetomidine** will be administered as a loading dose of **1 μg/kg over 10 minutes** (**0.5 μg/kg** in patients at risk of bradycardia), followed by a continuous infusion at a rate of **0.2 μg/kg/h** until the end of surgery. Systolic blood pressure. Timepoint: Every 15 minutes during surgery, immediately upon arrival in the post-anesthesia care unit (PACU), and every 15 minutes for one hour after admission to the PACU. Method of measurement: Measured in **millimeters of mercury (mmHg)** using a **calibrated noninvasive blood pressure monitor**. Diastolic blood pressure. Timepoint: Every 15 minutes during surgery, immediately upon arrival in the post-anesthesia care unit (PACU), and every 15 minutes for one hour after admission to the PACU. Method of measurement: Measured in **millimeters of mercury (mmHg)** using a **calibrated noninvasive blood pressure monitor**. Heart Rate. Timepoint: Every 15 minutes during surgery, immediately upon arrival in the post-anesthesia care unit (PACU), and every 15 minutes for one hour after admission to the PACU. Method of measurement: Cardiac Monitoring. Mean Arterial Pressure. Timepoint: Every 15 minutes during surgery, immediately upon arrival in the post-anesthesia care unit (PACU), and every 15 minutes for one hour after admission to the PACU. Method of measurement: Measured in **millimeters of mercury (mmHg)** using a **calibrated noninvasive blood pressure monitor**. Depth of Anesthesia. Timepoint: هر 15 دقیقه حین عمل تا پایان عمل. Method of measurement: Bispectral Index (BIS) monitor. Esfahan University of Medical Sciences Approved 2026-05-24 **Research Ethics Committee, School of Medicine, Isfahan University of Medical Sciences** No. 4 Building, Vice Chancellor for Research and Technology, Isfahan University of Medical Sciences and Health Services, Hezar Jarib Street, Isfahan, Iran. اصفهان Isfehan Iran (Islamic Republic of)