Intravenous Lignocaine vs Placebo

Hemodynamic Stability Post Intubation in Laryngoscopy Surgery Clinical Trial

Official title:

Effect of Intravenous Lignocaine vs Placebo on Hemodynamic Response During Intubation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03787069
• Other study ID #: IRD_IRB_2017_07_002
• Status: Completed
• Phase: Phase 3
• Start date: December 20, 2017
• Est. completion date: July 20, 2018

Study information

• Verified date: December 2018
• Source: Indus Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: July 20, 2018
• Est. primary completion date: July 20, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Hemodynamic Stability Post Intubation in Laryngoscopy Surgery

Intervention

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

Locations

Country	Name	City	State
Pakistan	The Indus Hospital	Karachi	Sind

Sponsors (1)

Lead Sponsor	Collaborator
Indus Hospital

Country where clinical trial is conducted

Pakistan, 

Outcome

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