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Intravenous Lignocaine vs Placebo

NCT ID: NCT03787069

Last Updated: 2018-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-20

Study Completion Date

2018-07-20

Brief Summary

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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

Detailed Description

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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.

Conditions

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Hemodynamic Stability Post Intubation in Laryngoscopy Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Equal allocation
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Lignocaine group

This group will be given 1.5 mg/kg I/V lignocaine before intubation

Group Type EXPERIMENTAL

iv Lignocaine vs placebo

Intervention Type DRUG

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

Placebo

This group will be given 6 ml normal saline before intubation

Group Type PLACEBO_COMPARATOR

iv Lignocaine vs placebo

Intervention Type DRUG

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

Interventions

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iv Lignocaine vs placebo

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Indus Hospital and Health Network

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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The Indus Hospital

Karachi, Sindh, Pakistan

Site Status

Countries

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Pakistan

Other Identifiers

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IRD_IRB_2017_07_002

Identifier Type: -

Identifier Source: org_study_id