Magnesium Sulphate and Extubation Quality

NCT05858957 | Completed Phase 4

• 1 other identifier: Extubation quality
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

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.

Conditions

Perioperative Complication

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• extubation time

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

Study Arms (2)

Magnesium

EXPERIMENTAL

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

Saline

ACTIVE COMPARATOR

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

Interventions

Magnesium sulfate DRUG

magnesium sulphate IV 30 mg/kg (10 min) infusion apply to the Group M

Also known as: Intravenous magnesium infusion

Magnesium

Saline DRUG

100 ml saline infusion apply to the Group S

Also known as: Saline infusion

Saline

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age over
• American society of Anesthesiology (ASA) clinical status I-III
• the patients who experience larynx micro surgery

You may not qualify if:

• under 18 years old
• ASA IV and over
• severe airway obstruction
• neuromuscular disease
• presence of tracheostomy

Sponsors & Collaborators

• Cukurova University: lead

Study Sites (1)

Cukurova University

Adana, 01380, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Magnesium Sulfate; Sodium Chloride

Intervention Hierarchy (Ancestors)

Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Sodium Compounds

Study Officials

• ebru biricik

  çukurova university faculty of medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: April 18, 2023
• First Posted: May 15, 2023
• Study Start: April 20, 2023
• Primary Completion: July 15, 2023
• Study Completion: July 30, 2023
• Last Updated: January 17, 2024

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)