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OpenTrials
Completed

NCT Number: NCT03787069

Intravenous Lignocaine vs Placebo

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

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Key information

Conditions

Hemodynamic Stability Post Intubation in Laryngoscopy Surgery

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

The Indus Hospital

Karachi, Sindh, 75500, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

iv Lignocaine vs placebo

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

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Indus Hospital and Health Network

Other

Registry information

Official study title

Effect of Intravenous Lignocaine vs Placebo on Hemodynamic Response During Intubation

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Dec 26, 2018
Registry last updated
Dec 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.