NCT03787069

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Dec 2017

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 20, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2018

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 24, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 26, 2018

Completed
Last Updated

December 26, 2018

Status Verified

December 1, 2018

Enrollment Period

7 months

First QC Date

December 24, 2018

Last Update Submit

December 24, 2018

Conditions

Hemodynamic Stability Post Intubation in Laryngoscopy Surgery

Outcome Measures

Primary Outcomes (2)

  • MAP

    mean arterial pressure

    post-intubation 3 minutes to 10 minutes

  • Pulse

    Heart rate

    post-intubation 3 minutes to 10 minutes

Study Arms (2)

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

iv Lignocaine vs placeboDRUG

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 groupPlacebo

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • ASA I and II
  • Age 20-60 years
  • Mallampatti , II
  • All surgeries are done under GA
  • Both genders
  • Those patients giving informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Indus Hospital

Karachi, Sindh, 75500, Pakistan

Location

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Equal allocation
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 24, 2018

First Posted

December 26, 2018

Study Start

December 20, 2017

Primary Completion

July 20, 2018

Study Completion

July 20, 2018

Last Updated

December 26, 2018

Record last verified: 2018-12

Locations

PA(1)