Ignite Creation Date:
2024-05-06 @ 3:43 AM
Last Modification Date:
2024-10-26 @ 11:38 AM
Study NCT ID:
NCT02359370
Status:
COMPLETED
Last Update Posted:
2015-02-10
First Post:
2015-01-31
Brief Title:
The Effects of Lidocaine and Magnesium Sulphate on the Attenuation of the Hemodynamic Response to Tracheal Intubation
Sponsor:
Hospital de Base
Organization:
Hospital de Base
Study Overview
Official Title:
The Effects of Lidocaine and Magnesium Sulphate on the Attenuation of the Hemodynamic Response to Tracheal Intubation Single Center Prospective Double-Blind and Randomized Study
Status:
COMPLETED
Status Verified Date:
2015-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Justification and Objectives The hemodynamic response to stimuli of the airways is a common phenomenon and its control is important to decrease systemic repercussions The objective of this study is to compare the effects of intravenous administration of Magnesium Sulphate versus Lidocaine in the hemodynamics of this reflex after laryngoscopy and tracheal intubation Methods This double blind randomized single center and prospective study evaluated 56 patients ASA 1 or 2 aged between 18 and 65 years scheduled for elective surgeries under general anesthesia with tracheal intubation Patients were divided into two groups Group M received 30mgkg of Magnesium Sulphate and group L 2 mgkg of Lidocaine through continuous infusion immediately before induction of anesthesia The values for blood pressure BP heart rate HR and bispectral index BIS were measured in both groups at six distinct moments related to the administration of the drugs under study
Detailed Description:
This double-blind randomized single center prospective study was approved by the Local Research Ethics Committee FEPECSSES-DF under the report number 799112 and has been identified on the Plataforma Brasil httpaplicacaosaudegovbrplataformabrasil under CAAE Certificate of Presentation for Ethical Consideration number 33365114700005553 After written informed consent 56 patients ASA P1 or P2 aged between 18 and 65 years scheduled for elective surgeries with orotracheal intubation OTI were assessed regarding their eligibility between the months of September and November 2014 Of the 56 patients selected for the study according to the inclusion criteria 7 were excluded during the evaluations four from group M because of frequent ventricular extrasystoles introduction of nasal swab of adrenaline before the end of evaluations intubation with video-laryngoscope and lack of sevoflurane in the vaporizer not checked during the evaluations Three more patients were excluded from group L one because of leakage of drugs poorly secured venous access another because of vomiting with consequent aspiration during ventilation with mask and another for failed intubation in the first laryngoscopy
When arriving in the surgery room the patient was first identified followed by standard monitoring with cardioscope ECG peripheral oxygen saturation SpO2 noninvasive blood pressure NIBP and bispectral index BIS Venoclysis was performed at the discretion of the anesthesiologist in accordance with the scale of the surgeryanesthesia Admission time Next the pre-anesthetic medication was administered with midazolam MDZ in the dose of 005mgkg After two minutes Time 2 after-MDZ the infusion with the drug under study was started with a dose of 2mgkg for lidocaine or 30mgkg for magnesium sulphate both diluted in 15mL of solution and infused in 10 minutes through a continuous infusion pump CIP After finishing the infusion Time End-CIP pre-oxygenation and anesthetic induction with intravenous fentanyl 2mcgkg was performed followed by propofol 2 mgkg and rocuronium 06 mgkg Time after-Ind The laryngoscopy was performed three minutes after the end of the rocuronium injection and if the BIS value was equal to or less than 50 Time after-OTI If the BIS value was not reached a venous increment of 1mgkg of propofol was administered After orotracheal intubation anesthesia was maintained through inhalation with sevoflurane 2 and new measurements were taken after 3 and 6 minutes of intubation Times 3 after-OTI and 6 after-OTI Hypertension was considered when the BP values were 20 above baseline values or if Systolic Blood Pressure SBP 140 mmHg Hypotension was considered when the Blood Pressure BP values were 20 below baseline values or if SBP 90 mmHg Tachycardia was considered when the Heart Rate HR values were 20 above baseline values or if HR 100 mmHg Bradycardia was considered for HR values under 50 bpm
When arriving in the surgery room the patient was first identified followed by standard monitoring with cardioscope ECG peripheral oxygen saturation SpO2 noninvasive blood pressure NIBP and bispectral index BIS Venoclysis was performed at the discretion of the anesthesiologist in accordance with the scale of the surgeryanesthesia Admission time Next the pre-anesthetic medication was administered with midazolam MDZ in the dose of 005mgkg After two minutes Time 2 after-MDZ the infusion with the drug under study was started with a dose of 2mgkg for lidocaine or 30mgkg for magnesium sulphate both diluted in 15mL of solution and infused in 10 minutes through a continuous infusion pump CIP After finishing the infusion Time End-CIP pre-oxygenation and anesthetic induction with intravenous fentanyl 2mcgkg was performed followed by propofol 2 mgkg and rocuronium 06 mgkg Time after-Ind The laryngoscopy was performed three minutes after the end of the rocuronium injection and if the BIS value was equal to or less than 50 Time after-OTI If the BIS value was not reached a venous increment of 1mgkg of propofol was administered After orotracheal intubation anesthesia was maintained through inhalation with sevoflurane 2 and new measurements were taken after 3 and 6 minutes of intubation Times 3 after-OTI and 6 after-OTI Hypertension was considered when the BP values were 20 above baseline values or if Systolic Blood Pressure SBP 140 mmHg Hypotension was considered when the Blood Pressure BP values were 20 below baseline values or if SBP 90 mmHg Tachycardia was considered when the Heart Rate HR values were 20 above baseline values or if HR 100 mmHg Bradycardia was considered for HR values under 50 bpm
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None