Intravenous Lignocaine vs Placebo

Phase 3

Completed

• Conditions: Hemodynamic Stability Post Intubation in Laryngoscopy Surgery
• Interventions: Drug: iv Lignocaine vs placebo

• Registration Number: NCT03787069
• Lead Sponsor: Indus Hospital and Health Network

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.

Study Timeline

• Study Start: 2017-12-20
• Primary Completion: 2018-07-20
• Study Completion: 2018-07-20
• Status Verified: 2018-12
• Study First Submitted: 2018-12-24
• Study First Submitted QC: 2018-12-24
• Last Update Submitted: 2018-12-24
• Study First Posted: 2018-12-26
• Last Update Posted: 2018-12-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lignocaine group	iv Lignocaine vs placebo	This group will be given 1.5 mg/kg I/V lignocaine before intubation
Placebo	iv Lignocaine vs placebo	This group will be given 6 ml normal saline before intubation

Primary Outcome Measures

Name	Time	Method
MAP	post-intubation 3 minutes to 10 minutes	mean arterial pressure
Pulse	post-intubation 3 minutes to 10 minutes	Heart rate

Trial Locations

Locations (1)

The Indus Hospital; 🇵🇰 Karachi, Sind, Pakistan