FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/05/067165 [Registered on: 10/05/2024] Trial Registered Prospectively
Last Modified On: 09/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study compares the effects of Dexmedetomidine administered via trachea versus vein on recovery process and peri-extubation cough prevention. Patients and evaluators remain unaware of treatment assignment 
Scientific Title of Study   Comparison of effect of low dose intratracheal and intravenous dexmedetomidine administration on recovery from general anaesthesia after abdominal surgery: a randomised double blinded study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Chanda Khatri 
Designation  Professor 
Affiliation  Dr S N Medical college 
Address  Janana Wing, Dr. S N Medical College, Department of Anaesthesiology, Sector D, Shastri Nagar, Jodhpur, Rajasthan

Jodhpur
RAJASTHAN
342003
India 
Phone  88619236716  
Fax    
Email  chandakhatri90@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Piyush Nawal 
Designation  PG Student 
Affiliation  Dr S N Medical college 
Address  Janana Wing, Dr. S N Medical College, Department of Anaesthesiology, Sector D, Shastri Nagar, Jodhpur, Rajasthan.

Jodhpur
RAJASTHAN
342003
India 
Phone  9518739860  
Fax    
Email  piyushnawal30@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Piyush Nawal 
Designation  PG STUDENT 
Affiliation  Dr S N Medical college 
Address  Janana Wing, Dr. S N Medical College, Department of Anaesthesiology, Sector D, Shastri Nagar, Jodhpur, Rajasthan

Jodhpur
RAJASTHAN
342003
India 
Phone  9518739860  
Fax    
Email  piyushnawal30@gmail.com  
 
Source of Monetary or Material Support  
Dr S N Medical College, Department of Anesthesiology  
 
Primary Sponsor  
Name  Dr S N Medical college 
Address  Dr. S N Medical College, Department of Anaesthesiology, Sector D, Shastri Nagar, Jodhpur, Rajasthan 
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 Piyush Nawal  DR S N MEDICAL COLLEGE  Department of Anaesthesiology, Main OT, A-5, near Central Laboratory, Sector H, Shastri Nagar, Jodhpur, Rajasthan.
Jodhpur
RAJASTHAN 		 9518739860

piyushnawal30@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Dr SNMC INSTITUTIONAL ETHICS COMMITTEE   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K800||Calculus of gallbladder with acutecholecystitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Intratracheal dexmedetomidine  The medications tagged with the study group, administered intratracheally half hour before the end of the surgery Dex (0.3mcg/kg, diluted and mixed in 2mL saline) will be sprayed down the intratracheal tube of patients in the DT group with needle of 5 ml syringe followed by positive breath, total duration of intervention will be from half hour before end of surgery to half hour post extubation 
Comparator Agent  Intravenous dexmedetomidine  The patients in the DV group will be intravenously given the same dose of Dexmedetomidine (0.3mcg/kg diluted in 20 ml NS) 15 minutes prior to the end of surgery as an infusion over 10 min, total duration of intervention will be from fifteen minutes before end of surgery to half hour post extubation 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Individuals of both genders aged between 18 and 60 years, with a weight falling within the range of 40 to 80 kg with physical status American Society of Anaesthesiologists (ASA) I and II, undergoing elective abdominal surgery under general anaesthesia will be included. 
 
ExclusionCriteria 
Details  1) Long term use of sedative drugs (benzodiazepines, barbiturates),
2) Anticipated difficult airway,
3) Those who received alpha2 agonists preoperatively,
4) Patients who were transferred to open surgery during the operation were excluded from the final analysis. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
The primary outcome will include severity of cough at extubation assessed by 4 point cough scale   0 minutes, 2 minutes, 5 minutes, 15 minutes, 30 minutes post extubation 
 
Secondary Outcome  
Outcome  TimePoints 
Monitoring of hemodynamic parameters  5 min before anaesthesia(T0), immediately after administration of dexmedetomidine(T1), 5 min after DEXMEDETOMIDINE(T2), 10 min after DEXMEDETOMIDINE(T3), at end of surgery(T4), at awareness(T5), at extubation(T6), 2 min after extubation(T7), 5 min after extubation(T8), 15 min after extubation(T9), 30 min after extubation(T10) 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
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)   20/05/2024 
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 - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [PIYUSHNAWAL30@GMAIL.COM].

  6. For how long will this data be available start date provided 30-12-2024 and end date provided 30-12-2029?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  
Emergence from general anaesthesia can result in a number of undesirable side effects including cough, hypertension, tachycardia, and agitation. These side effects may cause haemorrhage from the surgical wound site and also increase the in intraocular and intracranial pressures. Dexmedetomidine emerges as a potent alpha-2-selective adrenoceptor agonist, inducing sympatholysis, sedation, and analgesia without compromising respiratory function. The instillation of local anesthetics and dexmedetomidine directly into the trachea emerges as a promising strategy to counter laryngeal reflexes, gaining credibility in real-world clinical practices. Hence our aim is to compare the efficacy of Intratracheal dexmedetomidine (Dex) vs Intravenous dexmedetomidine injection for recovery from general anaesthesia following abdominal surgery.
 
Close