Intravenous Lignocaine vs Placebo

Indus Hospital and Health Network120 enrolled

Overview

To assess the mean hemodynamic responses post-intubation in patients given intravenous lignocaine pre-intubation as compared to a placebo pre-intubation in patients undergoing laryngoscopy surgery

After identifying the candidate, details will be carefully discussed with the subject. The subject (or, when necessary, the parent or legal guardian if the subject is younger than 18 years of age or under guardianship) will be read the approved protocol consent form. Patients who have given informed consent to participate in the study will be randomized into one of the two study arms one day before the procedure. The study team present will open the sealed envelopes provided by the Indus Hospital Research Center's Clinical Research Unit (CRU) that provides the study arm allocation. The envelopes will follow the SNOSE protocol.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

120

Conditions

Hemodynamic Stability Post Intubation in Laryngoscopy Surgery

Interventions

iv Lignocaine vs placeboDRUG

Lignocaine is available in an ampule of 10 ml containing 20 mg/ml of lignocaine or 2%, Lignocaine will be given in dose of 1.5 mg/kg I/V

Eligibility

Sex: ALLMin age: 20 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * ASA I and II * Age 20-60 years * Mallampatti , II * All surgeries are done under GA * Both genders * Those patients giving informed consent Exclusion Criteria: * Difficult airway assessed during pre-op anaesthesia assessment * Unanticipated difficult airway based on the previous history of difficult intubation * BMI \>30, * Micrognathia and microglossia based on pre-op anaesthesia assessment, * Diabetic patient with autonomic dysfunction liver disease, cardiovascular disease, pheochromocytoma, Cushing syndrome * Patients who do not give informed consent

Locations (1)

The Indus Hospital

Karachi, Sindh, Pakistan

Outcomes

Primary Outcomes

MAP

mean arterial pressure

Time frame: post-intubation 3 minutes to 10 minutes

Pulse

Heart rate

Time frame: post-intubation 3 minutes to 10 minutes

Data from ClinicalTrials.gov

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