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IRCT20210118050069N1 IRCT 2021-01-27 Research Institute of Ophthalmology Magnesium sulfate as an adjuvant to peribulbar block for glaucoma surgery in morbidly obese patients Safety and efficacy of magnesium sulfate as an adjuvant to peribulbar block for glaucoma surgery in morbidly obese patients: A randomized clinical trial 2021-02-01 anticipated 46 Complete https://irct.ir/trial/53749 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not 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 46 identical, opaque, letter-sized envelopes. We used rolls of household aluminum cooking foil that we cut into 46 sheets (of the same width as and twice the height of the envelope). We prepared 46 envelope-sized sheets of white paper and 46 envelope-sized sheets of single sided carbon paper. We wrote “Treatment A” on 23 paper sheets and “Treatment B” on another 23 sheets. To prepare 23 “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 23 “Treatment A” envelops the same way. We prepared 23 “Treatment B” envelops the same way as “Treatment A” envelops. The two sets of envelops were combined and shuffled thoroughly. Using a pen we marked a number on the front of each envelope sequentially from 1 to 46. Logically, 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: All of the following will be blinded to the type of intervention: Participants, Care providers (carrying out the peribulbar block), Health professionals (assessing the participants' outcomes), and Data analyzers. 2 Peribulbar block in adult, morbidly obese patients undergoing glaucoma surgery.. Intervention 1: Intervention group 1 (MS-75): This group will be given peribulbar anesthesia with a local anesthetic mixture composed of 4 ml of lidocaine 2% (Sunny Pharmaceutical, Egypt), 4 ml of bupivacaine 0.5% (Sunny Pharmaceutical, Egypt), and 1 ml of hyaluronidase (Shreya Life Sciences Pvt. Ltd., India) (at a concentration of 10 IU/ml of lidocaine) to which 75 mg of magnesium sulfate (EIPICO Pharmaceutical, Egypt) will be added. Intervention 2: Intervention group 2 (MS-100): This group will be given peribulbar anesthesia with a local anesthetic mixture composed of 4 ml of lidocaine 2% (Sunny Pharmaceutical, Egypt), 4 ml of bupivacaine 0.5% (Sunny Pharmaceutical, Egypt), and 1 ml of hyaluronidase (Shreya Life Sciences Pvt. Ltd., India) (at a concentration of 10 IU/ml of lidocaine) to which 100 mg of magnesium sulfate (EIPICO Pharmaceutical, Egypt) will be added. Yes - There is a plan to make this available What will be shared: Magnesium sulfate in peribulbar block for glaucoma surgery IPD set (all collected deidentified IPD). When: Beginning 6 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 principal investigator (A proposal for the use of data to be submitted to the principal investigator). How to obtain: A proposal for the use of data to be submitted to the principal investigator, then evaluated by an independent review committee identified for this purpose. Comments:
public Dr. Norhan Sherif
2 El Ahram Street
Giza Egypt 12557 +20 2 35718304 anesth.sherif@gmail.com Research Institute of Ophthalmology scientific Dr. Norhan Sherif
2 El Ahram Street
Giza Egypt 12557 +20 2 35718304 anesth.sherif@gmail.com Research Institute of Ophthalmology Egypt Glaucoma surgery patients ASA physical status I, II, or III Aged from 18 to 70 years Axial length 20-28 mm Body mass index 30-55 kg/m2 18 years 70 years Both Coagulopathy or use of anticoagulant drugs Previous allergy or adverse reaction to the used drugs Patients with conditions preventing them from lying flat or staying still during operation as skeletal problems, orthopneic patients, or those with uncontrolled tremors (as Parkinsonism) H40 Glaucoma Other Other Intervention group 1 (MS-75): This group will be given peribulbar anesthesia with a local anesthetic mixture composed of 4 ml of lidocaine 2% (Sunny Pharmaceutical, Egypt), 4 ml of bupivacaine 0.5% (Sunny Pharmaceutical, Egypt), and 1 ml of hyaluronidase (Shreya Life Sciences Pvt. Ltd., India) (at a concentration of 10 IU/ml of lidocaine) to which 75 mg of magnesium sulfate (EIPICO Pharmaceutical, Egypt) will be added. Intervention group 2 (MS-100): This group will be given peribulbar anesthesia with a local anesthetic mixture composed of 4 ml of lidocaine 2% (Sunny Pharmaceutical, Egypt), 4 ml of bupivacaine 0.5% (Sunny Pharmaceutical, Egypt), and 1 ml of hyaluronidase (Shreya Life Sciences Pvt. Ltd., India) (at a concentration of 10 IU/ml of lidocaine) to which 100 mg of magnesium sulfate (EIPICO Pharmaceutical, Egypt) will be added. The onset of globe akinesia. Timepoint: At 1, 3, and 5 min after the block. Method of measurement: The 3-point scale. The onset of lid akinesia. Timepoint: At 1, 3, and 5 min after the block. Method of measurement: The 3-point scale. The intraocular pressure. Timepoint: At baseline, 1, 3, and 5 minutes after local anesthesia. Method of measurement: Schiotz tonometer. The duration of analgesia. Timepoint: At 1, 2, and 4 h postoperative. Method of measurement: The Visual Analogue Scale. The duration of motor block. Timepoint: At 1, 2, and 4 h postoperative. Method of measurement: Clinical assessment of regaining full movement. Patient satisfaction. Timepoint: Immediately after the block. Method of measurement: Asking the patient. Surgeon satisfaction. Timepoint: Immediately after the block. Method of measurement: Asking the surgeon. The vital data (heart rate, oxygen saturation, and non-invasive blood pressure). Timepoint: Every 5 minutes during the operation. Method of measurement: Electronic vital signs monitor. Self-funded Approved 2020-11-08 Research Ethical Committee of the Research Institute of Ophthalmology 2 El Ahram Street Giza Cairo Egypt