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Intravenous Lignocaine vs Placebo

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03787069
Recruitment Status : Completed
First Posted : December 25, 2018
Last Update Posted : December 25, 2018
Sponsor:
Information provided by (Responsible Party):
Indus Hospital

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Hemodynamic Stability Post Intubation in Laryngoscopy Surgery Drug: iv Lignocaine vs placebo Phase 3

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Equal allocation
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effect of Intravenous Lignocaine vs Placebo on Hemodynamic Response During Intubation
Actual Study Start Date : December 20, 2017
Actual Primary Completion Date : July 20, 2018
Actual Study Completion Date : July 20, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Lignocaine group
This group will be given 1.5 mg/kg I/V lignocaine before intubation
Drug: 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

Placebo Comparator: Placebo
This group will be given 6 ml normal saline before intubation
Drug: 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




Primary Outcome Measures :
  1. MAP [ Time Frame: post-intubation 3 minutes to 10 minutes ]
    mean arterial pressure

  2. Pulse [ Time Frame: post-intubation 3 minutes to 10 minutes ]
    Heart rate



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03787069


Locations
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Pakistan
The Indus Hospital
Karachi, Sind, Pakistan, 75500
Sponsors and Collaborators
Indus Hospital

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Responsible Party: Indus Hospital
ClinicalTrials.gov Identifier: NCT03787069     History of Changes
Other Study ID Numbers: IRD_IRB_2017_07_002
First Posted: December 25, 2018    Key Record Dates
Last Update Posted: December 25, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action