| 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
|
|
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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 |
|
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Regulatory Clearance Status from DCGI
|
|
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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 |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
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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
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- 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
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [faridmalik1387@gmail.com].
- 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.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
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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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