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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05858957
Other study ID # Extubation quality
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date April 20, 2023
Est. completion date July 30, 2023

Study information

Verified date April 2023
Source Cukurova University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The investigators aimed to search effect of magnesium Sulfate on extubation quality scores, recovery and pain in larynx micro surgery. The patients allocated to two groups to receive magnesium sulfate 30 mg/kg in 100 ml saline infusion (maximum 2g) (Group m) or saline 100 ml (Group S) before induction of anesthesia. Anesthesia induction performed with propofol 2 mg/kg, rocuronium 0.6 mg/kg, remifentanil 0.5 µg/kg and general anesthesia maintained with total intravenous anesthesia (propofol 3-7 mg/kg, remifentanil 0.05-0.1 µg/kg/min and O2/air 30/70 mixture) to the all patients. Extubation quality scores, Extubation time, NRS scores were assessed.


Description:

The investigators aimed to search effect of magnesium sulfate on extubation quality, recovery feature and complications.98 adult patients scheduled for larynx laser microsurgery were included and randomly allocated to two groups to receive magnesium sulfate 30 mg/kg in 100 ml saline infusion (maximum 2g) (Group m) or saline 100 ml (Group S) before induction of anesthesia. Anesthesia induction performed with propofol 2 mg/kg, rocuronium 0.6 mg/kg, remifentanil 0.5 µg/kg and general anesthesia maintained with total intravenous anesthesia (propofol 3-7 mg/kg, remifentanil 0.05-0.1 µg/kg/min and O2/air 30/70 mixture) to the all patients. Paracetamol 15 mg/kg applied to all patients.Extubation quality score, extubation time, stay in postanesthesia unit (PACU) time, numeric rating scale (NRS) and complications were recorded.


Recruitment information / eligibility

Status Completed
Enrollment 98
Est. completion date July 30, 2023
Est. primary completion date July 15, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria: - 18 age over - American society of Anesthesiology (ASA) clinical status I-III - the patients who experience larynx micro surgery Exclusion Criteria: - under 18 years old - ASA IV and over - severe airway obstruction - neuromuscular disease - presence of tracheostomy

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Magnesium sulfate
magnesium sulphate IV 30 mg/kg (10 min) infusion apply to the Group M
Saline
100 ml saline infusion apply to the Group S

Locations

Country Name City State
Turkey Cukurova University Adana

Sponsors (1)

Lead Sponsor Collaborator
Cukurova University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary extubation quality scores Extubation quality will assess with quality scores such as no cough, Mild cough, moderate cough, severe cough. at the time between stop the total intravenous anesthesia and extubation of patient (last 20 min of anesthesia).
Secondary extubation time The time need to adequate spontaneous ventilation at recovery period time between stop the total intravenous anesthesia and extubation of patient (last 20 min of anesthesia).
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