Vitamin C Level Effect in Orthognathic Surgery

NCT04416386 | Completed

• 1 other identifier: Medipol Hospital 12
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Maxillofacial Abnormalities; Maxillofacial Injuries; Maxillofacial Trauma

Outcome Measures

Primary Outcomes (1)

• Blood plasma levels of vitamin C

  Pre and post-operative blood plasma levels of vitamin C

  Change from baseline blood plasma levels of vitamin C at postoperative 1, 2, 4, 8, 16 hours

Secondary Outcomes (1)

• Opioid consumption

  Change from baseline opioid consumption levels at postoperative 1, 2, 4, 8, 16 hours

Interventions

Vitamin C OTHER

Pre and post-operative blood plasma levels of vitamin C will be investigated

Eligibility Criteria

• Age: 19 Years - 38 Years
• Sex: all
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• American Society of Anesthesiologists (ASA) classification I-II
• Scheduled for orthognatic surgery under general anesthesia

You may not qualify if:

• history of bleeding diathesis,
• receiving anticoagulant treatment,
• known local anesthetics and opioid allergy,
• infection of the skin at the site of the needle puncture,
• pregnancy or lactation,
• patients who do not accept the procedure

Sponsors & Collaborators

• Medipol University: lead

Study Sites (1)

Istanbul Medipol University Hospital

Istanbul, Bagcilar, 34070, Turkey (Türkiye)

Location

Related Publications (3)

• Fukushima R, Yamazaki E. Vitamin C requirement in surgical patients. Curr Opin Clin Nutr Metab Care. 2010 Nov;13(6):669-76. doi: 10.1097/MCO.0b013e32833e05bc.

  PMID: 20689415 BACKGROUND

• Jeon Y, Park JS, Moon S, Yeo J. Effect of Intravenous High Dose Vitamin C on Postoperative Pain and Morphine Use after Laparoscopic Colectomy: A Randomized Controlled Trial. Pain Res Manag. 2016;2016:9147279. doi: 10.1155/2016/9147279. Epub 2016 Oct 30.

  PMID: 27872555 BACKGROUND

• Pirbudak L, Balat O, Cekmen M, Ugur MG, Aygun S, Oner U. Effect of ascorbic acid on surgical stress response in gynecologic surgery. Int J Clin Pract. 2004 Oct;58(10):928-31. doi: 10.1111/j.1742-1241.2004.00022.x.

  PMID: 15587771 BACKGROUND

MeSH Terms

Conditions

Maxillofacial Abnormalities; Maxillofacial Injuries

Interventions

Ascorbic Acid

Condition Hierarchy (Ancestors)

Craniofacial Abnormalities; Musculoskeletal Abnormalities; Musculoskeletal Diseases; Stomatognathic System Abnormalities; Stomatognathic Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Facial Injuries; Craniocerebral Trauma; Trauma, Nervous System; Nervous System Diseases; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 2, 2020
• First Posted: June 4, 2020
• Study Start: June 13, 2020
• Primary Completion: March 30, 2022
• Study Completion: March 30, 2022
• Last Updated: July 26, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)