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IRCT20250112064367N1 IRCT 2025-02-06 Arak University of Medical Sciences The effect of ondansetron, pethidine, and dexmedetomidine on postoperative shivering. Comparing Ondansetron, Pethidine, Dexmedetomidine as adjuant therapy to neuroaxial Marcaine 5% in postoperative shivering in patients undergoing TURP 2025-03-21 anticipated 81 Complete https://irct.ir/trial/81438 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients are randomly assigned into three equal groups using a blocked randomization method with blocks of six. The random sequence is generated using an online program available on www.sealedenvelope.com. (https://www.sealedenvelope.com/) Allocation concealment is ensured using the opaque sealed envelope method, Blinding description: The study will be conducted in a double-blind design. All patients will be randomly allocated into three equal groups using a block randomization method. Medications will be prepared and labeled as A, B, and C under the supervision of the principal investigator, with the preparation carried out by a trained anesthesia technician. The principal investigator will be aware of the group allocations. The intern, responsible for data collection and questionnaire completion, will remain blinded to the group assignments to ensure unbiased outcome assessment. 2-3 postoperative shivering in patients undergoing TURP. Intervention 1: Group 1:Patients will receive 75 mg of Bupivacaine (Exir Pharmaceutical, Iran) combined with 1–1.5 cc of Ondansetron (Caspian Tamin Pharmaceutical, Iran) via the neuraxial route. Intervention 2: Group 2:Patients will receive 75 mg of Bupivacaine (Exir Pharmaceutical, Iran) combined with 10–15 mg of Pethidine (Aburaihan Pharmaceutical, Iran) via the neuraxial route. Intervention 3: Group 3:Patients will receive 75 mg of Bupivacaine (Exir Pharmaceutical, Iran) combined with 10–15 mcg of Dexmedetomidine (Exir Pharmaceutical, Iran) via the neuraxial route. Yes - There is a plan to make this available What will be shared: Final result When: A few months after the results were published To whom: Academic and scientific institutions Conditions: Use in proposals and articles Where to obtain: Fatemeh Akhavan malayeri fateme.akhavan2021@gmail.com How to obtain: fateme.akhavan2021@gmail.com Comments:
public Rasoul Jafari
Hazrat Valiasr Educational and Medical Center, Hazrat Valiasr Square, Arak
Arak Iran (Islamic Republic of) 3814957558 +98 86 3222 2003 Fateme.akhavan2021@gmail.com Arak University of Medical Sciences scientific Rasoul Jafari
Hazrat Valiasr Educational and Medical Center, Hazrat Valiasr Square, Arak
Arak Iran (Islamic Republic of) 3814957558 +98 86 3222 2003 fateme.akhavan2021@gmail.com Arak University of Medical Sciences Iran (Islamic Republic of) Patients undergoing TURP referred to Vali-Asr and Amir Al-Momenin Hospitals in Arak. Patients with informed consent for participation in the study. Patients aged 35 to 70 years Patients classified as ASA Class I and II Patients with no cardiovascular, respiratory, or renal diseases. Patients with no history of cerebrovascular accident (CVA). Patients who are not IV drug abusers All patients undergoing spinal anesthesia No allergy to Marcaine, Ondansetron, Pethidine, or Dexmedetomidine. 35 years 70 years Male All patients for whom spinal anesthesia fails during surgery, requiring conversion to general anesthesia. All patients who experience cardiopulmonary arrest for any reason during surgery. All patients who, for any reason, require general anesthesia. Treatment - Drugs Treatment - Drugs Treatment - Drugs Group 1:Patients will receive 75 mg of Bupivacaine (Exir Pharmaceutical, Iran) combined with 1–1.5 cc of Ondansetron (Caspian Tamin Pharmaceutical, Iran) via the neuraxial route. Group 2:Patients will receive 75 mg of Bupivacaine (Exir Pharmaceutical, Iran) combined with 10–15 mg of Pethidine (Aburaihan Pharmaceutical, Iran) via the neuraxial route. Group 3:Patients will receive 75 mg of Bupivacaine (Exir Pharmaceutical, Iran) combined with 10–15 mcg of Dexmedetomidine (Exir Pharmaceutical, Iran) via the neuraxial route. The occurrence or absence of shivering in patients. Timepoint: The occurrence of shivering and pain score in patients at 2, 4, 6, and 8 hours postoperatively. Method of measurement: VAS questionnaire. Arak University of Medical Sciences Approved 2025-01-07 Ethics committee of Arak University of Medical Sciences Building 870, Deylami Ave, Azod Ave, Abbas Abbad Street, Arak Arak Markazi Iran (Islamic Republic of)