D Vitamin Effects on Neuromuscular Blocker Reverse Time

NCT03734250 | Completed

• 1 other identifier: 2014.04.02.221
• Study Type: observational
• Target: 84
• Locations: 0 countries
• Sites: N/A

Brief Summary

Background/aim: Investigators aimed to investigate the effect of D vitamin levels on Sugammadex and Neostigmine reverse durations in the study. Materials and methods: Eighty patients between 18 and 65 years, with ASA I-III status who were undergoing surgery under general anaesthesia were included the study. All patients were randomly divided into two groups with double blindness and 1.25 (OH) 2 vitamin D, 25 (OH) 2 vitamin D, and calcium levels were measured. At the end of the operation, 2 mg/kg of Sugammadex was administered to one group and Atropine + Neostigmine to the other group. The patients were also divided into two groups as to whether their vitamin D levels were ≥ 30 ng/mL or below. A train of four values was recorded after a hypnotic agent was given at the beginning and throughout the operation. The time to complete the disappearance of response to TOF stimulation was recorded as T0. End of the operation: When 2 responses to TOF stimulation were taken, the following times were recorded until the extubation phase by administering at least 2 mg/kg of Sugammadex or 0.05 mg/kg of Neostigmine 0.05 mg/kg of Atropine per kg of body weight. The time until the TOF value reached 50,70,90% and extubation were recorded.

Conditions

Vitamin D Deficiency; Neuromuscular Block; Neuromuscular Block Problem

Keywords

Sugammadex; Neostigmine; Anesthesia; Neuromuscular blockers; Reverse time; Vitamin D

Outcome Measures

Primary Outcomes (1)

• Reverse times

  The time until the TOF value reaches 50,70,90% and extubation were recorded.

  10 minute

Secondary Outcomes (1)

• Rocuronium effect unset time

  4 minute

Study Arms (4)

Group Sugammadex HD

Sugammadex used as neuromuscular blocker reverse agent with Vitamin D status equal or above 30ng/ml

Group neostigmine HD

Neostigmine used as neuromuscular blocker reverse agent with Vitamin D status equal or above 30 ng/ml

Group Sugammadex LD

Sugammadex used as neuromuscular reverse agent with Vitamin D status under 30 ng/ml

Group Neostigmine LD

Neostigmine used as neuromuscular reverse agent with Vitamin D status under 30ng/ml

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Eighty four patients with ASA I-III status undergoing surgery under general anesthesia between the ages of 18 and 65 years were included the study

You may qualify if:

• undergoing surgery under general anesthesia
• ASA I-III
• between the ages of 18 and 65 years old.

You may not qualify if:

• diabetes
• kidney
• muscle
• hepatic diseases
• metabolic diseases

Sponsors & Collaborators

• Duzce University: lead

Related Publications (1)

• Holick MF. Vitamin D status: measurement, interpretation, and clinical application. Ann Epidemiol. 2009 Feb;19(2):73-8. doi: 10.1016/j.annepidem.2007.12.001. Epub 2008 Mar 10.

  PMID: 18329892 BACKGROUND

Related Links

• Pubmed

Biospecimen

Retention: SAMPLES WITHOUT DNA

Venous blood samples 20 ml

MeSH Terms

Conditions

Vitamin D Deficiency

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• İlknur S Yorulmaz, Dr

  Duzce University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2018
• First Posted: November 7, 2018
• Study Start: November 1, 2014
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2018
• Last Updated: November 7, 2018

Record last verified: 2018-11