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Preoperative Vitamin D Levels and Respiratory Complications of General Anesthesia (VitaminD)

Primary Purpose

Vitamin D Deficiency

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Vitamin D

About this trial

This is an interventional diagnostic trial for Vitamin D Deficiency focused on measuring Vitamin D, general anesthesia, respiratory complications

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

- American Society of Anesthesiologists I - II risk classification, healthy adult surgery cases

Exclusion Criteria:

Thoracic surgery, those with severe respiratory, neuromuscular or endocrine system diseases, those with difficult intubation, morbid obesity, using vitamin D supplements and those who smoked

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Observational research

Arm Description

Vitamin D levels and respiratory complications; observational research.

Outcomes

Primary Outcome Measures

Relationship between Vitamin D levels and respiratory complications

Low vitamin D levels may be a potential risk in terms of respiratory complications related to general anesthesia

Secondary Outcome Measures

Full Information

NCT ID

NCT03342651

First Posted

October 8, 2017

Last Updated

November 13, 2017

Sponsor

T.C. ORDU ÜNİVERSİTESİ

1. Study Identification

Unique Protocol Identification Number

NCT03342651

Brief Title

Preoperative Vitamin D Levels and Respiratory Complications of General Anesthesia

Acronym

VitaminD

Official Title

Evaluation of the Effect of Preoperative Vitamin D Levels and Respiratory Complications of General Anesthesia

Study Type

Interventional

2. Study Status

Record Verification Date

November 2017

Overall Recruitment Status

Completed

Study Start Date

April 1, 2015 (Actual)

Primary Completion Date

April 1, 2016 (Actual)

Study Completion Date

December 31, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

T.C. ORDU ÜNİVERSİTESİ

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

Vitamin D deficiency is a commonly observed health problem in the world. With a role in many chronic diseases and especially lung diseases, the importance of vitamin D deficiency in anesthesia management is increased. This research aims to investigate whether there is a correlation between the respiratory complications occurring in patients under general anesthesia and preoperative vitamin D levels.

Detailed Description

This study included 95 adult cases aged from 18-65 years operated under general anesthesia. The cases had total 25-hydroxyvitamin D (25OHD) levels identified in blood samples before the operation. Patients given routine general anesthesia and postoperative monitoring procedures were assessed in terms of respiratory complications during anesthesia induction, extubation, anesthesia recovery and the first 24 hours postoperative. This research observed that patients with low preoperative 25OHD vitamin levels encountered respiratory complications related to general anesthesia more often. Especially in the early postoperative period there is a very significant difference between complications and low 25OHD vitamin levels. Our study results show that low vitamin D levels may be a potential risk in terms of respiratory complications related to general anesthesia causing severe morbidity and mortality increase. The results lead to the consideration that optimizing vitamin D levels in the preoperative period for patients undergoing general anesthesia may aid in reducing complications.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Vitamin D Deficiency

Keywords

Vitamin D, general anesthesia, respiratory complications

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

95 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Observational research

Arm Type

Other

Arm Description

Vitamin D levels and respiratory complications; observational research.

Intervention Type

Other

Intervention Name(s)

Vitamin D

Other Intervention Name(s)

Anesthesia, respiratory complications

Intervention Description

Vitamin D, general anesthesia, respiratory complications

Primary Outcome Measure Information:

Title

Relationship between Vitamin D levels and respiratory complications

Description

Low vitamin D levels may be a potential risk in terms of respiratory complications related to general anesthesia

Time Frame

Perioperative period

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: - American Society of Anesthesiologists I - II risk classification, healthy adult surgery cases Exclusion Criteria: Thoracic surgery, those with severe respiratory, neuromuscular or endocrine system diseases, those with difficult intubation, morbid obesity, using vitamin D supplements and those who smoked

Overall Study Officials: