Intravenous Lignocaine vs Placebo | NCT03787069

Studies
Intravenous Lignocaine vs Placebo

NCT03787069

Sponsor

Indus Hospital and Health Network

Status

Completed

Last Update Posted

Dec 26, 2018Actual

Enrollment

120Actual

Phase

Phase 3

Conditions

Hemodynamic Stability Post Intubation in Laryngoscopy Surgery

Interventions

iv Lignocaine vs placebo

Countries

Pakistan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 20, 2017Actual

Primary Completion Date

Jul 20, 2018Actual

Completion Date

Jul 20, 2018Actual

First Submitted Date

Dec 24, 2018

First Submission Date that Met QC Criteria

Dec 24, 2018

First Posted Date

Dec 26, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 24, 2018

Last Update Posted Date

Dec 26, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120Actual

Arms/Interventions Module

Arm Groups

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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
iv Lignocaine vs placebo	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	Lignocaine group

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Indus Hospital		Karachi	Sindh	75500	Pakistan

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided