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CTRI Number  CTRI/2024/03/064770 [Registered on: 26/03/2024] Trial Registered Prospectively
Last Modified On: 21/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To compare the efficacy of dexamethasone and dexmedetomidine in post operative sore throat in adult patients undergoing laproscopic cholecystectomy .  
Scientific Title of Study   To compare the efficacy of intravenous dexamethasone and dexmedetomidine in post operative sore throat(POST) on adult surgical patients in laproscopic cholecystectomy - a randomized control trial . 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mohammad Fariduddin Malik 
Designation  Junior Resident 
Affiliation  Department of Anaesthesiology and Critical care JNMC AMU Aligarh UTTAR PRADESH 
Address  Department of Anaesthesiology and Critical Care Jawaharlal Nehru Medical College , Aligarh Muslim University

Aligarh
UTTAR PRADESH
202002
India 
Phone  8266898303  
Fax    
Email  faridmalik1387@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Syed Hussain Amir 
Designation  Associate professor 
Affiliation  Department of Anaesthesiology and Critical care JNMC AMU Aligarh UTTAR PRADESH 
Address  Department of Anaesthesiology and Critical care Jawaharlal Nehru Medical College , Aligarh Muslim University

Aligarh
UTTAR PRADESH
202002
India 
Phone  9897559183  
Fax    
Email  hussainamir77@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Mohammad Fariduddin Malik 
Designation  Junior Resident 
Affiliation  Department of Anaesthesiology and Critical care JNMC AMU Aligarh UTTAR PRADESH 
Address  Department of Anaesthesiology and Critical care Jawaharlal Nehru Medical College , Aligarh Muslim University

Aligarh
UTTAR PRADESH
202002
India 
Phone  8266898303  
Fax    
Email  faridmalik1387@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesiology and Critical care Jawaharlal Nehru Medical College , Aligarh Muslim University UTTAR PRADESH  
 
Primary Sponsor  
Name  Jawaharlal Nehru Medical College and hospital  
Address  Department of Anesthesiology and critical care Jawaharlal Nehru Medical College , Aligarh Muslim University, Uttar Pradesh 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Mohammad Fariduddin Malik  Jawaharlal Nehru Medical College  Department of Anaesthesiology and Critical care Jawaharlal Nehru Medical College , Aligarh Muslim University
Aligarh
UTTAR PRADESH 
8266898303

faridmalik1387@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Faculty of Medicine Jawaharlal Nehru Medical College and hospital Aligarh Muslim University   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  , (1) ICD-10 Condition: K802||Calculus of gallbladder without cholecystitis, (2) ICD-10 Condition: K802||Calculus of gallbladder without cholecystitis, (3) ICD-10 Condition: K802||Calculus of gallbladder without cholecystitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  compare the efficacy of intravenous dexamethasone and dexmedetomidine   To compare the efficacy of intravenous dexamethasone and dexmedetomidine in post operative sore throat on adult surgical patients undergoing laparoscopic cholecystectomy -a randomised controlled trial  
Intervention  Intravenous dexamethasone and dexmedetomidine   To compare the efficacy of intravenous dexamethasone and dexmedetomidine in post operative adult surgical patients undergoing laparoscopic cholecystectomy  
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  ASA grade 1 and grade 2
age between 20 - 60 years
weight between 30 - 80 kg
patient planned for elective laproscopic cholecystectomy surgeries 
 
ExclusionCriteria 
Details  patient already on steroid therapy
surgery more than one hour
history of smoking
diabetes mellitus , pregnancy
NSAID use within 24 hrs before surgery
recent history of respiratory tract infection
risk factor for postoperative aspiration
cardiac hepatic or major renal disease
neuromuscular disease 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
to compare the incidence of sore throat  to compare the incidence of sore throat within 24 hours 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the sensitivity of sore throat
To compare the duration of sore throat
To compare the incidence & severity of hoarseness
Complication if any  
To compare related secondary outcomes within 24 hours 
 
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   Phase 3/ Phase 4 
Date of First Enrollment (India)   02/04/2024 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [faridmalik1387@gmail.com].

  6. For how long will this data be available start date provided 15-03-2024 and end date provided 04-01-2025?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary  
Post-operative sore throat (POST) is caused by transient irritation to the local mucosa of the oropharynx or trachea after intubation-related manipulations is one of the most undesirable intubation-related complications with an estimated incidence of 14.5% to 65%. POST can significantly reduce the patients’ satisfaction level and affect their recovery.1

Numerous factors including age, female gender, smoking history, size of the endotracheal tube, cuff pressure, time and manipulations needed to insert the tube, and time of operation and anaesthesia may affect the incidence of POST, causing discomfort and dissatisfaction.2

Sore throat is often the predominant post-operative complaint when surgical pain is well controlled, particularly by local/regional analgesia. Factors contributing to the development of sore throat include trauma to pharyngolaryngeal mucosa from laryngoscopy, placement of a nasogastric tube, or oral suctioning, cuff design, pressure affecting tracheal mucosal capillary perfusion and contact of the tracheal tube with the vocal cords and posterior pharyngeal wall resulting in edema or mucosal lesions.3

A lot of research work has been published in past for reducing POST and hoarseness of voice either as non-pharmacological or pharmacological methods. Non-pharmacological methods includes use of appropriate size of endotracheal tube, presence or absence of cuff or use of airway adjuncts like stylet or bougie, and pharmacological methods includes various drugs administered intravenous or topically. These drugs include ketamine, lignocaine, aspirin, dexamethasone dexmedetomidine and magnesium sulfate.4

Dexamethasone is a potent corticosteroid with analgesic, anti-inflammatory and antiemetic action. Pre-operative dexamethasone has been reported to reduce the incidence of post-operative pain. It reduces the production of inflammatory mediator prostaglandins and leukotrienes. The mechanism behind this is inhibition of phospholipase-A2 through production of calcium-dependent phospholipid-binding proteins known as annexins and cyclooxygenase.5

Dexmedetomidine, a selective α2-adrenaline receptor agonist, has a dose-dependent sedative effect on respiration with minimal depressive effects. It also attenuates the inflammatory response. Several clinical experiments have been conducted to investigate the efficacy and safety of dexmedetomidine for the prevention of POST.6

It is a very versatile drug in anaesthesia practice, finding place in increasing number of clinical scenarios. Dexmedetomidine enhances anaesthesia produced by other anaesthetic drugs, causes pre-operative sympatholysis and decreases blood pressure by stimulating central α2 and imidazoline receptors.
Higher affinity to α2 receptor selectively leads to vagomimetic action on heart (bradycardia) and vasodilatation. The role as an antishivering agent and diuretic is yet to be established.7

Dexamethasone and Dexmedetomidine reduces the incidence of postoperative sore throat, pain and swelling because they act as an anti-inflammatory mediator.8

Accordingly, dexmedetomidine has been widely used as an adjunctive drug by anaesthetists during clinical procedures and surgeries. Tracheal intubation may be one mechanism contributing to POST. Tracheal intubation, the most commonly used airway management method during general anaesthesia, is safe for future clinical work. Previous studies suggest that dexamethasone is effective in decreasing the incidence of POST when given via intravenous route.9

When we searched the literature, there was no study comparing the efficacy of intravenous dexmedetomidine and dexamethasone so we took up the present study.



 
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