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IRCT20230522058251N2 IRCT 2024-01-18 Shahid Beheshti University of Medical Sciences Investigating the effect of immersion in virtual reality on the amount of anesthetic drugs used during upper limb surgeries The impact of immersion in virtual reality on the amount of anesthetic drugs used during upper limb surgeries 2024-01-21 anticipated 50 Complete https://irct.ir/trial/74894 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: A pool of sealed, opaque envelopes containing a note with either of two phrases, 'Intervention Group' or 'Control Group,' is prepared in advance. Patients randomly chose one of these envelopes, and based on it, are allocated to either one of the two groups: intervention or control. 3 Condition 1: Fracture of lower end of radius. Condition 2: Carpal tunnel syndrome. Intervention 1: Intervention group: Candidates for upper limb surgery who, before the start of supraclavicular block and during the operation, are placed under virtual reality immersion and receive fentanyl and midazolam at the discretion of the anesthesiologist. Intervention 2: Control group: Candidates for upper limb surgery who, during supraclavicular block and during the surgery, receive fentanyl and midazolam according to the standard protocol and under the supervision of the anesthesiologist. Yes - There is a plan to make this available What will be shared: The data in this study include patients' age, gender, type of surgery, duration of the procedure, and the type and amount of anesthetic drug administered. All data will be anonymized to ensure patient confidentiality When: Data will be available as soon as the article is published To whom: Researchers in every university, or other scientific research institutes Conditions: The data will be anonymized to ensure patient confidentiality Where to obtain: To access data please contact the corresponding author using the contact information included in the published article How to obtain: The request should be formally submitted in a formal letterhead from the university or research institute as the requesting party for the corresponding author Comments:
public Mohammad Hossein Mahrooz
Akhtar hospital, Azar dead end,Sharifimanesh st, Shariati st, Tehran
Tehran Iran (Islamic Republic of) 1964714953 +98 21 2200 1072 mohamad.mahrooz@alum.sharif.edu Shahid Beheshti University of Medical Sciences scientific Amir Bisadi
Akhtar hospital, Azar dead end,Sharifimanesh st, Shariati st, Tehran
Tehran Iran (Islamic Republic of) 1964714953 +98 21 2200 1072 bisadi.md@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Indication for upper limb surgery Informed consent to participate in the clinical trial Age between 18 to 65 years 18 years 65 years Both Uncontrolled systemic diseases History of seizure History of migraine History of inner ear dysfunction S52.5 G56.0 Fracture of lower end of radius Carpal tunnel syndrome Treatment - Devices Treatment - Drugs Intervention group: Candidates for upper limb surgery who, before the start of supraclavicular block and during the operation, are placed under virtual reality immersion and receive fentanyl and midazolam at the discretion of the anesthesiologist Control group: Candidates for upper limb surgery who, during supraclavicular block and during the surgery, receive fentanyl and midazolam according to the standard protocol and under the supervision of the anesthesiologist The amount of anesthetic drug administered to the patient. Timepoint: before nerve block and during surgery. Method of measurement: The amount of Midazolam or Fentanyl injected to the patient as recorded in the surgery report note. Reza Minaei-Noshahr Approved 2023-10-28 Ethics committee of Shahid Beheshti University of medical sciences 7th Floor, Bldg No.2 SBMU, Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)