]>
IRCT20210106049952N1 IRCT 2021-01-10 Research Institute of Ophthalmology The effect of adding different doses of neostigmine in peribulbar block for cataract surgery The effect of adding different doses of neostigmine in peribulbar block for intraoperative anesthesia and post-operative analgesia in cataract surgery 2021-01-15 anticipated 60 Complete https://irct.ir/trial/53531 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: We used the sealed, opaque sequentially numbered envelopes method for randomization and allocation concealment of patients included in this trial. We used 60 identical, opaque, letter-sized envelopes. We used rolls of household aluminum cooking foil that we cut into 60 sheets (of the same width as and twice the height of the envelope). We prepared 60 envelope-sized sheets of white paper and 60 envelope-sized sheets of single sided carbon paper. We wrote “Treatment A” on 20 paper sheets, “Treatment B” on another 20 sheets, and “Treatment C” on the last 20 sheet. To prepare 20 “Treatment A” envelops, we selected one envelope-sized sheet of of Treatment A and placed one sheet of carbon paper on top of the Treatment A allocation paper with the carbon side facing the paper, then we put both papers inside a foil wrapper. Then, the completed insert was placed into a blank envelope with the carbon paper closest to the front of the envelope. Finally, the envelop was sealed and we signed across the seal. We completed all the 20 “Treatment A” envelops the same way. We prepared 20 “Treatment B” envelops and 20 “Treatment C” envelops the same way as “Treatment A” envelops. The three sets of envelops were combined and we shuffled them thoroughly. Then, using a pen we marked a number on the front of each envelope sequentially from 1 to 60. The carbon paper inside the envelope will transfer this number to the allocation paper inside. Finally, we placed these envelopes into a plastic container, in numerical order, ready for use, Blinding description: Participants, care providers carrying out the peribulbar block, and those assessing the participants' outcomes will be blinded to the type of intervention. 2 Peribulbar block in adult patients undergoing cataract surgery.. Intervention 1: Control group (Group C): Includes 20 patients. Each will receive 9 ml of lidocaine 2% (containing 1 ml = 10 unit of hyaluronidase) + 1 ml of saline. Intervention 2: Intervention group 1 (Group N1): Includes 20 patients. Each will receive 9 ml of lidocaine 2% (containing 1 ml = 10 unit of hyaluronidase) + 0.5 mg of neostigmine. Intervention 3: Intervention group 2 (Group N2): Includes 20 patients. Each will receive 9 ml of lidocaine 2% (containing 1 ml = 10 unit of hyaluronidase) + 0.25 mg of neostigmine. Yes - There is a plan to make this available What will be shared: Neostigmine in peribulbar block for cataract surgery IPD set (all collected deidentified IPD). When: Beginning 6 months and ending 36 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. Iman Sobhy
2 El Ahram Street
Giza Egypt 12557 +20 2 35718304 iman.sobhy333@gmail.com Research Institute of Ophthalmology scientific Dr. Iman Sobhy
2 El Ahram Street
Giza Egypt 12557 +20 2 35718304 iman.sobhy333@gmail.com Research Institute of Ophthalmology Egypt Cataract surgery patients (male or female) aged from 30 to 70 years ASA physical status I, II, or III 30 years 70 years Both Coagulopathy or use of anticoagulant drugs Infection at the site of surgery Posterior staphyloma Previous allergy or adverse reaction to the used drugs Bronchial asthma or bradyarrhythmia Other Other Other Control group (Group C): Includes 20 patients. Each will receive 9 ml of lidocaine 2% (containing 1 ml = 10 unit of hyaluronidase) + 1 ml of saline Intervention group 1 (Group N1): Includes 20 patients. Each will receive 9 ml of lidocaine 2% (containing 1 ml = 10 unit of hyaluronidase) + 0.5 mg of neostigmine Intervention group 2 (Group N2): Includes 20 patients. Each will receive 9 ml of lidocaine 2% (containing 1 ml = 10 unit of hyaluronidase) + 0.25 mg of neostigmine Hemodynamics (heart rate, blood pressure, and oxygen saturation). Timepoint: Baseline, immediately after the block, and one hour after the block. Method of measurement: Electronic vital signs monitor. Onset of sensory block. Timepoint: Every 5 seconds after the block. Method of measurement: Clinical assessment. Onset of motor block. Timepoint: Every 5 seconds after the block. Method of measurement: Clinical assessment. Duration of the block. Timepoint: Every 10 minutes following the block. Method of measurement: Clinical assessment. Postoperative pain. Timepoint: Immediately after the block. Method of measurement: Visual analog scale. Surgeon satisfaction. Timepoint: Immediately after the block. Method of measurement: Questioning. Patient satisfaction. Timepoint: Immediately after the block. Method of measurement: Questioning. First analgesic dose. Timepoint: Every 30 minutes. Method of measurement: Clinical assessment. Self-funded Approved 2020-12-01 Research Ethical Committee of the Research Institute of Ophthalmology 2 El Ahram Street Giza Cairo Egypt