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IRCT20210220050419N1 IRCT 2021-02-27 Research Institute of Ophthalmology Ketamine versus magnesium sulphate as an adjuvant to local anesthetics in the peribulbar block for posterior segment surgeries Ketamine versus magnesium sulphate as an adjuvant to local anesthetics in the peribulbar block for posterior segment surgeries: A randomized controlled study 2019-04-01 anticipated 126 Complete https://irct.ir/trial/54441 interventional Randomization: Randomized, Blinding: Double 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 126 identical, opaque, letter-sized envelopes lined with sheets of household aluminum cooking foil to ensure opacity. We prepared 126 envelope-sized sheets of white paper and 126 envelope-sized sheets of single sided carbon paper. We wrote “Treatment A” on 42 paper sheets, “Treatment B” on another 42 sheets, and “Treatment C” on the last 42 sheets. To prepare 42 “Treatment A” envelops, we selected one envelope-sized sheet 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 inserted both into a blank envelope with the carbon paper closest to the front of the envelope. Finally, we sealed the envelop and signed across the seal. We completed all the 42 “Treatment A” envelops the same way. We prepared 42 “Treatment B” as well as 42 “Treatment C” envelops similar to “Treatment A” envelops. The three 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 126 so the carbon paper inside the envelope transfer this number to the allocation paper inside. Finally, we placed these envelopes into a large plastic container, in numerical order, ready for use, Blinding description: The study participants and care providers (carrying out the peribulbar block and assessing the participants' outcomes) were blinded to the type of intervention. 2 Peribulbar block in adult patients undergoing posterior segment surgeries.. Intervention 1: Control group (GC) received peribulbar anesthesia with a local anesthetic mixture composed of lidocaine 2% (4.5 ml), plain bupivacaine 0.5% (4.5 ml), 1 ml of normal saline, and hyaluronidase (13.5 IU per ml of the local anesthetic mixture). Intervention 2: Intervention group (GK) received a local anesthetic mixture composed of lidocaine 2% (4.5 ml), plain bupivacaine 0.5% (4.5 ml), 25 mg of ketamine in 1 ml of normal saline, and hyaluronidase (13.5 IU per ml of the local anesthetic mixture). Intervention 3: Intervention group (GM) received a local anesthetic mixture composed of lidocaine 2% (4.5 ml), plain bupivacaine 0.5% (4.5 ml), 50 mg of magnesium sulphate in 1 ml of normal saline, and hyaluronidase (13.5 IU per ml of the local anesthetic mixture). Yes - There is a plan to make this available What will be shared: Ketamine and magnesium sulphate in peribulbar block for posterior segment surgeries 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-analyses. Where to obtain: From the principal investigator (A proposal for the use of data to be submitted to the principal investigator). How to obtain: 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. Eslam Saleh
2 El Ahram Street
Giza Egypt 31527 +20 2 35718304 dr.eslam.m.saleh@gmial.com Research Institute of Ophthalmology scientific Dr. Eslam Saleh
2 El Ahram Street
Giza Egypt 31527 +20 2 35718304 dr.eslam.m.saleh@gmial.com Research Institute of Ophthalmology Egypt Posterior segment operations American Society of Anesthesiologist (ASA) physical status I or II Age: 45-65 years Axial length: < 25 mm 45 years 65 years Both Coagulation abnormalities Impaired mental status Allergy to any of the study medications Problems that interfere with surgeon patient communication and cooperation as deafness Severe cardiac disease, chronic obstructive lung disease, history of sleep apnea, advanced liver or kidney disease History of chronic use of sedatives, narcotics, alcohol or drug abuse Patient refusal Other Other Other Control group (GC) received peribulbar anesthesia with a local anesthetic mixture composed of lidocaine 2% (4.5 ml), plain bupivacaine 0.5% (4.5 ml), 1 ml of normal saline, and hyaluronidase (13.5 IU per ml of the local anesthetic mixture). Intervention group (GK) received a local anesthetic mixture composed of lidocaine 2% (4.5 ml), plain bupivacaine 0.5% (4.5 ml), 25 mg of ketamine in 1 ml of normal saline, and hyaluronidase (13.5 IU per ml of the local anesthetic mixture). Intervention group (GM) received a local anesthetic mixture composed of lidocaine 2% (4.5 ml), plain bupivacaine 0.5% (4.5 ml), 50 mg of magnesium sulphate in 1 ml of normal saline, and hyaluronidase (13.5 IU per ml of the local anesthetic mixture). The onset of sensory block. Timepoint: At 1, 2, 3, 4, and 5 min after the block. Method of measurement: A small piece of cotton wool. The onset of globe akinesia. Timepoint: At 1, 3, 5, 7, and 10 min after the block. Method of measurement: The 3-point scale. The Duration of lid akinesia. Timepoint: At 1, 2, 3, 4, and 5 h postoperative. Method of measurement: Clinical assessment of regaining full movement. The duration of globe akinesia. Timepoint: At 1, 2, 3, 4, and 5 h postoperative. Method of measurement: Clinical assessment of regaining full movement. Patient satisfaction. Timepoint: After recovery. Method of measurement: 7-point Likert-like verbal rating scale. Surgeon satisfaction. Timepoint: At the end of surgery. Method of measurement: The 7-point Likert-like verbal rating scale. The duration of analgesia. Timepoint: At 1, 2, 3, 4, and 5 h postoperative. Method of measurement: The 10-point Visual Analog Scale. The intraocular pressure. Timepoint: At baseline and 10 minutes after injection of the local anesthetics. Method of measurement: Schiotz tonometer. Time to start surgery. Timepoint: At 1, 3, 5, 7, and 10 min after the block. Method of measurement: Corneal anesthesia together with an ocular movement score ≤1 in each direction and an eyelid akinesia score of 0 (total score <5). Self-funded Approved 2019-04-11 Research Ethical Committee of the Research Institute of Ophthalmology 2 El Ahram Street Giza Cairo Egypt