NCT06107543

Brief Summary

Direct laryngoscopy and endotracheal intubation procedure stimulate the sympathetic nervous system, causing catecholamine release into the circulation and consequently hemodynamic changes.There are many studies showing that lidocaine is used intravenously to suppress the sympathetic response to laryngoscopy and endotracheal intubation. Nebulized lidocaine is often used to provide upper airway local anesthesia in fiberoptic guided awake intubation. In this study, the researchers aimed to compare the results of using intravenous lidocaine and nebulized lidocaine to suppress the hemodynamic response caused by laryngoscopy and endotracheal intubation retrospectively. Researchers' hypothesis; Nebulized lidocaine administration is more effective than intravenous lidocaine administration in suppressing the hemodynamic response due to laryngoscopy and endotracheal intubation in patients under general anesthesia.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
94

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 4, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 30, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

December 1, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 22, 2024

Completed
Last Updated

June 25, 2024

Status Verified

June 1, 2024

Enrollment Period

6 months

First QC Date

September 4, 2023

Last Update Submit

June 24, 2024

Conditions

Keywords

LidocaineIntubationGeneral anaesthesia

Outcome Measures

Primary Outcomes (9)

  • Heart Rate

    Patients were monitored with a three-lead ECG in the operating room and their heart rates were recorded as beats per minute. (.../min)

    Just before induction of anesthesia

  • Heart Rate

    Patients were monitored with a three-lead ECG in the operating room and their heart rates were recorded as beats per minute. (.../min)

    Immediately after induction of anesthesia

  • Heart Rate

    Patients were monitored with a three-lead ECG in the operating room and their heart rates were recorded as beats per minute. (.../min)

    5 minutes and 10 minutes after direct laryngoscopy and endotracheal intubation

  • Blood Pressure

    The patients were monitored in the operating room by wearing a noninvasive blood pressure cuff and measurements were taken at 5-minute intervals. Systolic blood pressure, diastolic blood pressure and mean arterial pressure were recorded in mmHg.

    Just before induction of anesthesia

  • Blood Pressure

    The patients were monitored in the operating room by wearing a noninvasive blood pressure cuff and measurements were taken at 5-minute intervals. Systolic blood pressure, diastolic blood pressure and mean arterial pressure were recorded in mmHg.

    Immediately after induction of anesthesia

  • Blood Pressure

    The patients were monitored in the operating room by wearing a noninvasive blood pressure cuff and measurements were taken at 5-minute intervals. Systolic blood pressure, diastolic blood pressure and mean arterial pressure were recorded in mmHg.

    5 minutes and 10 minutes after direct laryngoscopy and endotracheal intubation

  • Oxygen Saturation

    The patients were monitored with a pulse oximetry device in the operating room and their oxygen saturation % (spO2) was recorded.

    Just before induction of anesthesia

  • Oxygen Saturation

    The patients were monitored with a pulse oximetry device in the operating room and their oxygen saturation % (spO2) was recorded.

    Immediately after induction of anesthesia

  • Oxygen Saturation

    The patients were monitored with a pulse oximetry device in the operating room and their oxygen saturation % (spO2) was recorded.

    5 minutes and 10 minutes after direct laryngoscopy and endotracheal intubation

Study Arms (2)

Intravenous lidocaine

Patients who received lidocaine intravenously before induction of anesthesia will be considered in this group.

Drug: Iv Lidocaine

Nebulized lidocaine

Patients who received lidocaine by inhalation with a nebulizer before induction of anesthesia will be considered in this group.

Drug: Nebulized Lidocaine

Interventions

Before induction of anesthesia, 2% lidocaine + physiological saline was added to a nebulizer and inhaled for 3-5 minutes in the presence of 4-6 liters/minute of oxygen.

Nebulized lidocaine

Intravenous %2 lidocaine was administered before induction of anesthesia.

Intravenous lidocaine

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

80 patients over the age of 18 and under the age of 80 who underwent surgery under general anesthesia in the operating room will be included in the study.

You may qualify if:

  • Patients over the age of 18 and under the age of 80 who underwent surgery under general anesthesia

You may not qualify if:

  • Patients under the age of 18 and over the age of 80
  • Patients who are not operated under general anesthesia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Derince Training and Research Hospital

Kocaeli, 41900, Turkey (Türkiye)

Location

Related Publications (2)

  • Baronia AK, Singh PK, Maheshwari A, Jain VK, Mittal P, Pant KC. Inhaled lidocaine for prevention of hemodynamic changes in laryngoscopy and intubation. J Neurosurg Anesthesiol. 1992 Jul;4(3):154-9. doi: 10.1097/00008506-199207000-00002.

  • Sklar BZ, Lurie S, Ezri T, Krichelli D, Savir I, Soroker D. Lidocaine inhalation attenuates the circulatory response to laryngoscopy and endotracheal intubation. J Clin Anesth. 1992 Sep-Oct;4(5):382-5. doi: 10.1016/0952-8180(92)90160-3.

MeSH Terms

Interventions

Lidocaine

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Anesthesiology and Reanimation

Study Record Dates

First Submitted

September 4, 2023

First Posted

October 30, 2023

Study Start

December 1, 2023

Primary Completion

June 1, 2024

Study Completion

June 22, 2024

Last Updated

June 25, 2024

Record last verified: 2024-06

Locations