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IRCT20201220049777N2 IRCT 2021-07-07 Research Institute of Ophthalmology Ketamine versus midazolam as an adjuvant to peribulbar block using single inferonasal injection in patients undergoing vitreoretinal surgery: A randomized controlled trial Ketamine versus midazolam as an adjuvant to peribulbar block using single inferonasal injection in patients undergoing vitreoretinal surgery: A randomized controlled trial 2021-07-15 anticipated 93 Complete https://irct.ir/trial/57202 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: We will use the sequentially numbered, opaque sealed envelopes method. We will use envelopes that are impermeable to intense light, and the allocation sequence will be concealed from the physicians enrolling and assessing participants. To prevent subversion of the allocation sequence, the name and hospital admission number of the participant will be written on the envelope. Carbon paper will transfer the information onto the allocation card inside the envelope. Corresponding envelopes will be opened only after the enrolled participants complete all baseline assessments and it is time to allocate the intervention, Blinding description: Only participants will be blinded to the type of intervention. 2 Peribulbar block in adult patients undergoing vitreoretinal surgeries.. Intervention 1: Control group (Group C) received peribulbar anesthesia with a local anesthetic mixture composed of 4 ml of lidocaine 2%, 75 units of hyaluronidase, and 4 ml of bupivacaine 0.5% to which 1 ml of normal saline is added. Intervention 2: Midazolam group (Group M) received peribulbar anesthesia with a local anesthetic mixture composed of 4 ml of lidocaine 2%, 75 units of hyaluronidase, and 4 ml of bupivacaine 0.5% to which 1 mg of midazolam is added. Intervention 3: Ketamine group (Group K) received peribulbar anesthesia with a local anesthetic mixture composed of 4 ml of lidocaine 2%, 75 units of hyaluronidase, and 4 ml of bupivacaine 0.5% to which 25 mg of ketamine is added. Yes - There is a plan to make this available What will be shared: Ketamine versus midazolam for peribulbar block in vitreoretinal surgeries IPD set (all collected deidentified IPD). When: Beginning 12 months and ending 24 months following article publication. To whom: Researchers from academic institutions whose proposal for the use of data has been approved by an independent review committee identified for this purpose. Conditions: For IPD meta-analysis. Where to obtain: From the PI. How to obtain: A proposal for the use of data to be submitted to the PI, then evaluated by an independent review committee identified for this purpose. Comments:
public Dr. Noha Osama
2 El Ahram Street
Giza Egypt 12557 +20 2 35718304 noha.a.osama22@gmail.com Research Institute of Ophthalmology scientific Dr. Noha Osama
2 El Ahram Street
Giza Egypt 12557 +20 2 35718304 noha.a.osama22@gmail.com Research Institute of Ophthalmology Egypt Patients undergoing vitreoretinal surgeries with axial length 20-29 mm Adults (male or female) aged from 30 to 65 years old American Society of Anesthesiologists (ASA) physical status I or II 30 years 65 years Both Uncooperative patients Patients who can’t lie flat for the duration of the procedure as those with skeletal problems or orthopneic patients Patients with coagulopathy or using anticoagulant drugs Other Other Other Control group (Group C) received peribulbar anesthesia with a local anesthetic mixture composed of 4 ml of lidocaine 2%, 75 units of hyaluronidase, and 4 ml of bupivacaine 0.5% to which 1 ml of normal saline is added. Midazolam group (Group M) received peribulbar anesthesia with a local anesthetic mixture composed of 4 ml of lidocaine 2%, 75 units of hyaluronidase, and 4 ml of bupivacaine 0.5% to which 1 mg of midazolam is added. Ketamine group (Group K) received peribulbar anesthesia with a local anesthetic mixture composed of 4 ml of lidocaine 2%, 75 units of hyaluronidase, and 4 ml of bupivacaine 0.5% to which 25 mg of ketamine is added. The onset of globe akinesia. Timepoint: At 1, 3, 5 minutes after the block. Method of measurement: The 3-point scale. The duration of analgesia. Timepoint: Time from the block till first analgesia required. Method of measurement: The 10-point Visual Analog Scale. The duration of motor block. Timepoint: At 1, 2, 3, 4, and 5 h postoperative. Method of measurement: Clinical assessment of regaining full movement. The onset of lid akinesia. Timepoint: At 1, 2, and 3 min after the block. Method of measurement: The 3-point scale. The onset of corneal anesthesia. Timepoint: At 15 seconds intervals for one minute after the block. Method of measurement: Clinical assessment using a cotton pad. The vital data (blood pressure, oxygen saturation, and pulse rate). Timepoint: Before giving the block (baseline) and then every 5 minutes after the block. Method of measurement: Clinical assessment. Self-funded Approved 2021-03-14 Research Ethical Committee of the Research Institute of Ophthalmology 2 El Ahram Street Giza Cairo Egypt