Vitamin C Level Effect in Orthognathic Surgery | NCT04416386

Studies
Vitamin C Level Effect in Orthognathic Surgery

NCT04416386

Sponsor

Medipol University

Status

Completed

Last Update Posted

Jul 26, 2022Actual

Enrollment

30Actual

Phase

Not provided

Conditions

Maxillofacial Abnormalities
Maxillofacial Injuries
Maxillofacial Trauma

Interventions

Vitamin C

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 13, 2020Actual

Primary Completion Date

Mar 30, 2022Actual

Completion Date

Mar 30, 2022Actual

First Submitted Date

Jun 2, 2020

First Submission Date that Met QC Criteria

Jun 2, 2020

First Posted Date

Jun 4, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 25, 2022

Last Update Posted Date

Jul 26, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Bahadir Ciftci, Principal Investigator, Medipol UniversityPrincipal Investigator

Lead Sponsor

Medipol UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Vitamin C	Other	Pre and post-operative blood plasma levels of vitamin C will be investigated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Opioid consumption	Postoperative opioid consumption	Change from baseline opioid consumption levels at postoperative 1, 2, 4, 8, 16 hours

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

38 Years

Standard Ages

Adult

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.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Istanbul Medipol University Hospital		Istanbul	Bagcilar	34070	Turkey (Türkiye)

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
20689415	Background	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.
27872555	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.

ID	Term
D019465	Craniofacial Abnormalities
D009139	Musculoskeletal Abnormalities
D009140	Musculoskeletal Diseases
D018640	Stomatognathic System Abnormalities

ID	Term
D013400	Sugar Acids
D000144	Acids, Acyclic
D002264	Carboxylic Acids
D009930	Organic Chemicals

ID	Term
D019767	Maxillofacial Abnormalities
D008446	Maxillofacial Injuries