An observational study in Maxillofacial Abnormalities, Maxillofacial Injuries and Maxillofacial Trauma, sponsored by Medipol University. Completed at 1 site in Turkey. Open to participants aged 19 Years to 38 Years. Per ClinicalTrials.gov, last updated 2022-07-26.
Sponsored by Medipol University · Observational
Comparing the pre and post-operative blood plasma levels of vitamin C according to oxidative stress and investigate the correlation between post-operative analgesia requirement and vitamin C levels following orthognathic surgery.
Vitamin C (ascorbic acid) is a water-soluble vitamin that has many functions include antioxidant, neuroprotective, neuromodulator and co-factor for various enzymes or chemical reactions. Primarily ascorbic acid is the most potent non-enzymatic antioxidant agent in an extracellular fluid which is crucial for defense against oxidative stress. Recent clinical studies have shown that trauma or surgery may lead to oxidative stress and plasma vitamin C level decreases due to body demand that most likely caused by oxidative stress.
Pain is defined as an unpleasant sensory and emotional experience associated with actual or potential tissue damage. One of the major purposes in the management of post-operative pain is to minimize the dose of medications to reduce side effects while providing adequate analgesia.
In orthopedic surgery and management of postherpetic neuralgia oral vitamin C supplementation significantly reduced pain. However, the decrease in vitamin C concentration,the effects on antinociception and postoperative pain are not fully understood.
In this study, investigators aimed to compare pre and post-operative blood plasma levels of vitamin C after orthognathic surgery and investigate a correlation between post-operative analgesia requirement and vitamin C levels without vitamin C administration.
21 studies on the registry are indexed under Maxillofacial Abnormalities; 2 are open to participants now.
Browse Maxillofacial Abnormalities studies →Medipol University is the lead sponsor of 326 studies on the registry; 88 are open to participants now.
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Orthognathic surgery patients aged between 19-38 years (mean age 27.17) with ASA I and ASA II status will be included in this randomized prospective study.
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The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Pre and post-operative blood plasma levels of vitamin C will be investigated
Blood plasma levels of vitamin C
Pre and post-operative blood plasma levels of vitamin C
Time frame: Change from baseline blood plasma levels of vitamin C at postoperative 1, 2, 4, 8, 16 hours
Opioid consumption
Postoperative opioid consumption
Time frame: Change from baseline opioid consumption levels at postoperative 1, 2, 4, 8, 16 hours
Plan to share: No — We will not plan to share IPD
Ran from Jun 2020 to primary completion in Mar 2022, 21 months.
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This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
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