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Magnesium Sulphate and Extubation Quality

Sponsor
Cukurova University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05858957
Collaborator
(none)
98
Enrollment
1
Location
2
Arms
3.4
Anticipated Duration (Months)
28.4
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Detailed 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
98 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Prevention
Official Title:
The Effect of Magnesium Sulfate on Extubation Quality Score and Recovery in Larynx Laser Microsurgery, Prospective, Randomized, Controlled Study
Actual Study Start Date :
Apr 1, 2023
Anticipated Primary Completion Date :
Jun 15, 2023
Anticipated Study Completion Date :
Jul 15, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Magnesium

Magnesium sulfate 30 mg/kg with 100 ml saline will apply in 10 min before induction of general anesthesia (maximum magnesium dose 2g) (Group M) . When the magnesium infusion completed, general anesthesia induction will start.

Drug: Magnesium sulfate
magnesium sulphate IV 30 mg/kg (10 min) infusion apply to the Group M
Other Names:
  • Intravenous magnesium infusion

    		•
    Active Comparator: Saline

    saline 100 ml will apply in 10 min before induction of general anesthesia (Group S) . When the saline infusion completed, general anesthesia induction will start.

    Drug: Saline
    100 ml saline infusion apply to the Group S
    Other Names:
  • Saline infusion

    		•

    Outcome Measures

    Primary Outcome Measures

    1. extubation quality scores [at the time between stop the total intravenous anesthesia and extubation of patient (last 20 min of anesthesia).]

      Extubation quality will assess with quality scores such as no cough, Mild cough, moderate cough, severe cough.

    Secondary Outcome Measures

    1. extubation time [time between stop the total intravenous anesthesia and extubation of patient (last 20 min of anesthesia).]

      The time need to adequate spontaneous ventilation at recovery period

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Cukurova University Adana Turkey 01380

    Sponsors and Collaborators

    • Cukurova University

    Investigators

    • Principal Investigator: ebru biricik, çukurova university faculty of medicine

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    ebru biricik, Associate professor, Cukurova University
    ClinicalTrials.gov Identifier:
    NCT05858957
    Other Study ID Numbers:
    • Extubation quality
    First Posted:
    May 15, 2023
    Last Update Posted:
    May 16, 2023
    Last Verified:
    Apr 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:
    Magnesium Sulfate

    Study Results

    No Results Posted as of May 16, 2023