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Intravenous Lignocaine vs Placebo

I

Indus Hospital and Health Network

Status and phase

Completed
Phase 3

Conditions

Hemodynamic Stability Post Intubation in Laryngoscopy Surgery

Treatments

Drug: iv Lignocaine vs placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT03787069
IRD_IRB_2017_07_002

Details and patient eligibility

About

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

Full 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.

Enrollment

120 patients

Sex

All

Ages

20 to 60 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

120 participants in 2 patient groups, including a placebo group

Lignocaine group
Experimental group
Description:
This group will be given 1.5 mg/kg I/V lignocaine before intubation
Treatment:
Drug: iv Lignocaine vs placebo
Placebo
Placebo Comparator group
Description:
This group will be given 6 ml normal saline before intubation
Treatment:
Drug: iv Lignocaine vs placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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