CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 32 enrolled
Drug / intervention
1.8% lidocaine plus 0.76% sodium bicarbonate +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03343080
NCT03343080Phase 2Completed

Lidocaine as an ETT Cuff Media in the Immediate Post-operative Cardiac Surgery Patient Population, and Its Effect on Sedation/Analgesia Requirements: a Pilot Study

Mayo Clinic·interventional·Posted Nov 17, 2017·Updated Sep 27, 2019

In Brief

A Phase 2 clinical trial evaluating 1.8% lidocaine plus 0.76% sodium bicarbonate and Air for Cardiac Disease. Completed, enrolled 32 participants across 1 site.

Detailed Summary

Researchers will compare the effects of lidocaine versus air, as a way to fill the breathing tube cuff which is gently inflated to hold in place the trachea (airway) during surgery. Air is the traditional method used to inflate the breathing tube cuff. Researchers wish to find if lidocaine works better than air to facilitate tolerance to the breathing tube (decreased coughing, sore throat, hoarseness). They also want to learn more about its effectiveness for this particular surgical intervention.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCardiac Disease
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedNov 17, 2017
Enrollment StartJul 27, 2018
Primary CompletionOct 1, 2018
Study CompletionAug 1, 2019
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 8.6 years ago

Interventions

1.8% lidocaine plus 0.76% sodium bicarbonatedrug

At the time of intubation, the endotracheal tube cuff will be inflated with a solution containing 1.8% lidocaine plus 0.76% sodium bicarbonate until loss of air leak at a positive pressure of 20 cm of water. This solution will remain in situ through the duration of cardiac surgery, transportation to the intensive care unit, and continued to the time of extubation.

Airother

At the time of intubation, the endotracheal tube cuff will be inflated with air until loss of air leak at a positive pressure of 20 cm of water. The air will remain in situ through the duration of cardiac surgery, transportation to the intensive care unit, and continued to the time of extubation.