Back to resultsBolus vs. Continuous IV Lidocaine Against Post-Extubation Cough in Post-Thyroidectomy Patients
Primary Purpose
Cough
Status
Completed
Phase
Phase 2
Locations
Indonesia
Study Type
Interventional
Intervention
Lidocaine IV
Sponsored by
About this trial
This is an interventional treatment trial for Cough
Eligibility Criteria
Inclusion Criteria: ASA class 1 and 2 Thyroidectomy patients in Hasan Sadikin Bandung Hospital Exclusion Criteria: Subjects' refusal Had history of drug allergy, specifically lidaocaine Had history of asthma or other lung diseases Active smoker History of arrhythmia Bradycardia subjects (<60 beats per minute) Pregnant people Perioperative upper respiratory tract infusion Routinely consume ACE inhibitor / bronchodilators / steroid Renal dysfunction Liver dysfunction
Sites / Locations
- Hasan Sadikin General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Continuous Lidocaine Intravenous Infusion
Bolus Lidocaine Intravenous
Arm Description
Patients were given a loading dose of 1.5 mg/kgBW intravenous lidocaine for 10 minutes before induction of anesthesia using a syringe pump, followed by continuous intravenous administration of 1.5 mg/kgBW/hour lidocaine until 30 minutes before the end of the surgery (when the skin is being sutured by the surgeon) using a syringe pump. Continuous administration of lidocaine was prepared by the research team as 10 cc of 20 mg/cc lidocaine in a 10 cc syringe and 10 cc of 0.9% NaCl in a 10 cc syringe.
Patients were given a loading dose of 1.5 mg/kgBW intravenous lidocaine for 10 minutes before induction of anesthesia using a syringe pump, followed by intravenous infusion of saline with the same volume until 30 minutes before the end of the surgery (when the skin is being sutured by the surgeon) using syringe pump.
Outcomes
Primary Outcome Measures
Post-Extubation Cough Grade
Cough graded according to the following criteria:
Grade 0: no cough; Grade 1: mild, only 1 cough; Grade 2: moderate, >1 cough lasting <5 seconds; Grade 3: coughing heavily and continuously for >5 seconds)
Secondary Outcome Measures
Number of participant experiencing tachycardia
Tachycardia is defined as heart rate >100 beats per minute
Number of participant experiencing bradycardia
Bradycardia is defined as heart rate <60 beats per minute
Number of participant experiencing hypertension
Increase of blood pressure >20% from initial blood pressure
Number of participant experiencing hypotension
Decrease of blood pressure <20% from initial blood pressure
Full Information
NCT ID
NCT06040034
First Posted
September 10, 2023
Last Updated
September 21, 2023
Sponsor
Universitas Padjadjaran
1. Study Identification
Unique Protocol Identification Number
NCT06040034
Brief Title
Bolus vs. Continuous IV Lidocaine Against Post-Extubation Cough in Post-Thyroidectomy Patients
Official Title
Comparison of Bolus Intravenous Lidocaine Administration With Continuous Intravenous Lidocaine Against Post-Extubation Cough Incidence in Post-Thyroidectomy Patients
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
February 2, 2023 (Actual)
Primary Completion Date
May 1, 2023 (Actual)
Study Completion Date
May 1, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitas Padjadjaran
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The goal of this randomized controlled trial is to compare the effect of lidocaine bolus intravenous administration to lidocaine continuous intravenous administration in post thyroidectomy patients to observe the effect against post-extubation cough. The main questions it aims to answer are:
Cough incidence on both groups
Which method is preferable to reduce post-extubation cough incidence
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cough
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Comparison
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Continuous Lidocaine Intravenous Infusion
Arm Type
Active Comparator
Arm Description
Patients were given a loading dose of 1.5 mg/kgBW intravenous lidocaine for 10 minutes before induction of anesthesia using a syringe pump, followed by continuous intravenous administration of 1.5 mg/kgBW/hour lidocaine until 30 minutes before the end of the surgery (when the skin is being sutured by the surgeon) using a syringe pump. Continuous administration of lidocaine was prepared by the research team as 10 cc of 20 mg/cc lidocaine in a 10 cc syringe and 10 cc of 0.9% NaCl in a 10 cc syringe.
Arm Title
Bolus Lidocaine Intravenous
Arm Type
Active Comparator
Arm Description
Patients were given a loading dose of 1.5 mg/kgBW intravenous lidocaine for 10 minutes before induction of anesthesia using a syringe pump, followed by intravenous infusion of saline with the same volume until 30 minutes before the end of the surgery (when the skin is being sutured by the surgeon) using syringe pump.
Intervention Type
Drug
Intervention Name(s)
Lidocaine IV
Intervention Description
Lidocaine given as bolus or continuous infusion.
Primary Outcome Measure Information:
Title
Post-Extubation Cough Grade
Description
Cough graded according to the following criteria:
Grade 0: no cough; Grade 1: mild, only 1 cough; Grade 2: moderate, >1 cough lasting <5 seconds; Grade 3: coughing heavily and continuously for >5 seconds)
Time Frame
24 hours post operative
Secondary Outcome Measure Information:
Title
Number of participant experiencing tachycardia
Description
Tachycardia is defined as heart rate >100 beats per minute
Time Frame
24 hours perioperative
Title
Number of participant experiencing bradycardia
Description
Bradycardia is defined as heart rate <60 beats per minute
Time Frame
24 hours perioperative
Title
Number of participant experiencing hypertension
Description
Increase of blood pressure >20% from initial blood pressure
Time Frame
24 hours perioperative
Title
Number of participant experiencing hypotension
Description
Decrease of blood pressure <20% from initial blood pressure
Time Frame
24 hours perioperative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
ASA class 1 and 2
Thyroidectomy patients in Hasan Sadikin Bandung Hospital
Exclusion Criteria:
Subjects' refusal
Had history of drug allergy, specifically lidaocaine
Had history of asthma or other lung diseases
Active smoker
History of arrhythmia
Bradycardia subjects (<60 beats per minute)
Pregnant people
Perioperative upper respiratory tract infusion
Routinely consume ACE inhibitor / bronchodilators / steroid
Renal dysfunction
Liver dysfunction
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Iwan Fuadi, MD
Organizational Affiliation
Faculty of Medicine Universitas Padjadjaran Bandung
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ardi Zulfariansyah, MD
Organizational Affiliation
Faculty of Medicine Universitas Padjadjaran Bandung
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ignatia K Hallis, MD
Organizational Affiliation
Faculty of Medicine Universitas Padjadjaran Bandung
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hasan Sadikin General Hospital
City
Bandung
State/Province
West Java
ZIP/Postal Code
40161
Country
Indonesia
12. IPD Sharing Statement
Learn more about this trial
Bolus vs. Continuous IV Lidocaine Against Post-Extubation Cough in Post-Thyroidectomy Patients
We'll reach out to this number within 24 hrs