Clinical trial

The Effect of Magnesium Sulfate on Extubation Quality Score and Recovery in Larynx Laser Microsurgery, Prospective, Randomized, Controlled Study

Name

Extubation quality

Description

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.

Trial arms

Trial start

2023-04-20

Estimated PCD

2023-07-15

Trial end

2023-07-30

Status

Completed

Phase

Early phase I

Treatment

Magnesium sulfate

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

Arms:

Magnesium

Other names:

Intravenous magnesium infusion

Saline

100 ml saline infusion apply to the Group S

Arms:

Saline

Other names:

Saline infusion

Size

Primary endpoint

extubation quality scores

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

Eligibility criteria

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 98, 'type': 'ACTUAL'}}

Updated at

2024-01-17

1 organization

1 product

1 drug

1 indication

Organization

Cukurova University

Product

Magnesium sulfate

Indication

Perioperative Complication

Drug

Varlilumab