Intravenous Lignocaine vs Placebo

NCT ID: NCT03787069

Last Updated: 2018-12-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-20
• Study Completion Date: 2018-07-20

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.

Conditions

Hemodynamic Stability Post Intubation in Laryngoscopy Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Lignocaine group

This group will be given 1.5 mg/kg I/V lignocaine before intubation

Group Type: EXPERIMENTAL

iv Lignocaine vs placebo

Intervention Type: 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

Placebo

This group will be given 6 ml normal saline before intubation

Group Type: PLACEBO_COMPARATOR

iv Lignocaine vs placebo

Intervention Type: 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

Interventions

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

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Indus Hospital and Health Network

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The Indus Hospital

Karachi, Sindh, Pakistan

Countries

Pakistan

Other Identifiers

IRD_IRB_2017_07_002

Identifier Type: -

Identifier Source: org_study_id