Intravenous Lignocaine vs Placebo

Effect of Intravenous Lignocaine vs Placebo on Hemodynamic Response During Intubation

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03787069

Enrollment

120

Registered

2018-12-26

Start date

2017-12-20

Completion date

2018-07-20

Last updated

2018-12-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemodynamic Stability Post Intubation in Laryngoscopy Surgery

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

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.

Interventions

DRUGiv 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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Intervention model description

Equal allocation

Eligibility

Sex/Gender

ALL

Age

20 Years to 60 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
MAP	post-intubation 3 minutes to 10 minutes	mean arterial pressure
Pulse	post-intubation 3 minutes to 10 minutes	Heart rate

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026