| CTRI Number |
CTRI/2024/07/070665 [Registered on: 16/07/2024] Trial Registered Prospectively |
| Last Modified On: |
|
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
Comparing Esmolol IV Infusion and 4% Lignocaine Nebulization for Minimizing Haemodynamic Changes during Laryngoscopy and Endotracheal Intubation: A Preoperative vs. Elective Surgery Study |
|
Scientific Title of Study
|
Attenuation of Haemodynamic Responses to Laryngoscopy and Endotracheal Intubation (Before and Elective Surgery): A Comparative Study Between Intravenous Esmolol and 4% Lignocaine Nebulisation |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pavithra |
| Designation |
Junior Resident |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Jawaharlal Nehru Medical College, Datta Meghe Institute of Higher Education and Research
Wardha
MAHARASHTRA
442001
India |
| Phone |
7020154259 |
| Fax |
|
| Email |
pkonjety19@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amol SIngham |
| Designation |
Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Jawaharlal Nehru Medical College, Datta Meghe Institute of Higher Education and Research
Wardha
MAHARASHTRA
442001
India |
| Phone |
7020154259 |
| Fax |
|
| Email |
amol.anesthesia@dmiher.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amol SIngham |
| Designation |
Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Jawaharlal Nehru Medical College, Datta Meghe Institute of Higher Education and Research
Wardha
MAHARASHTRA
442001
India |
| Phone |
7020154259 |
| Fax |
|
| Email |
amol.anesthesia@dmiher.edu.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute of Higher Education and Research |
| Address |
Datta Meghe Institute of Higher Education and Research |
| Type of Sponsor |
Other [] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Pavithra Konjety |
Datta Meghe Institute of Higher Education and Research |
Department of Anesthesia Jawaharlal Nehru Medical College Datta Meghe Institute of Higher Education and Research
Wardha
MAHARASHTRA |
9422538005
pkonjety19@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Datta Meghe Institute of Higher Education and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 8||Other Procedures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Administration of intravenous Esmolol at a dose of 1.5 mg/kg |
Participants are administered intravenous Esmolol at a dose of 1.5 mg/kg. Esmolol, a selective beta-1 adrenergic receptor antagonist, is delivered via intravenous bolus injection over a period of 15-20 seconds. This administration occurs one minute after the administration of vecuronium, a neuromuscular blocking agent, and two minutes before the planned endotracheal intubation. The purpose of Esmolol administration is to mitigate the hypertensive response typically induced by laryngoscopy and endotracheal intubation, achieved through the reduction of sympathetic nervous system activity and attenuation of cardiovascular stress effects. |
| Comparator Agent |
Administration of intravenous Magnesium Sulfate at a dose of 50 mg/kg |
Participants receive intravenous Magnesium Sulfate at a dose of 50 mg/kg. Magnesium Sulfate, known for its vasodilatory and antiarrhythmic properties, is administered intravenously as an infusion diluted in a compatible solution, such as normal saline. The infusion is completed over a 10-minute duration before the planned endotracheal intubation, preceding the induction of anesthesia. The mechanism of action of Magnesium Sulfate involves calcium channel blockade and modulation of neurotransmitter release. The objective of administering Magnesium Sulfate is to attenuate the hemodynamic stress response associated with airway manipulation during anesthesia induction, thereby contributing to improved patient outcomes. |
|
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Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Participants meeting specific criteria were included in the study. These criteria encompassed individuals aged between 15 to 60 years, falling within American Society of Anesthesiologists (ASA) physical status classification I and II, scheduled for elective Ear, Nose, and Throat (ENT) surgical procedures. Additionally, inclusion required participants to have provided valid informed consent, ensuring their understanding and willingness to participate in the study. These criteria aimed to establish a homogeneous participant group suitable for the investigation into the comparative efficacy of intravenous Esmolol and 4% Lignocaine nebulization in attenuating haemodynamic responses during laryngoscopy and endotracheal intubation. |
|
| ExclusionCriteria |
| Details |
Participants were excluded from the study if they did not meet the predefined inclusion criteria, including age, ASA status, and surgical type. Additionally, individuals with anticipated difficult intubation, uncontrolled hypertension or diabetes, a history of cardiac illness, neuromuscular disorders, hepatic disease, renal disease, known sensitivity to the drugs under investigation, cerebrovascular disease, or undergoing emergency surgery were excluded. Furthermore, patients with bronchial asthma or those currently receiving alpha and beta blockers were also excluded from participation. These exclusion criteria were established to mitigate confounding factors and ensure the safety and integrity of the study outcomes. |
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary outcome, attenuation of the hemodynamic stress response to laryngoscopy and endotracheal intubation |
The primary outcome, attenuation of the hemodynamic stress response to laryngoscopy and endotracheal intubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The secondary outcome of the study focuses on assessing the incidence of adverse events related to the study interventions and perioperative management. These adverse events may include hypotension, bradycardia, arrhythmias, or any other complications arising during the induction of anesthesia and endotracheal intubation procedures |
This period begins from the administration of the study drugs (Esmolol or Magnesium Sulfate) and extends until the completion of the endotracheal intubation procedure. Adverse events are monitored continuously throughout this timeframe, allowing for the immediate identification and management of any complications that may arise during anesthesia induction and airway manipulation. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/08/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The research investigates the efficacy of two pharmacological interventions, Esmolol and Magnesium Sulfate, in attenuating the hemodynamic stress response to laryngoscopy and endotracheal intubation. This randomized clinical trial involves patients aged 15 to 60 years, ASA I or II, undergoing elective ENT surgery. Participants are divided into two groups: one receiving Esmolol and the other receiving Magnesium Sulfate. Hemodynamic parameters are assessed at various time points throughout the peri-intubation period to evaluate the interventions’ effectiveness. Additionally, adverse events related to the interventions and perioperative management are monitored. The study aims to provide insights into optimizing perioperative care and enhancing patient safety during elective surgeries. |