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CTRI Number  CTRI/2021/07/035276 [Registered on: 29/07/2021] Trial Registered Prospectively
Last Modified On: 21/09/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   To compare the ability to prevent Nausea and Vomiting by Dexmedetomidine versus its combination with Dexamethasone after surgery of the abdomen in adult patients 
Scientific Title of Study   Comparison of intravenous Dexmedetomidine with Dexmedetomidine-Dexamethasone combination for prevention of Post-Operative Nausea and Vomiting in adult patients after abdominal surgeries 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Tanmay Yadav 
Designation  PG Resident 
Affiliation  Vardhman Mahavir Medical College and Safdarjung Hospital 
Address  Department of Anaesthesia and Intensive Care, Main OT Building, Vardhman Mahavir Medical College and Safdarjung Hospital, Ansari Nagar East, New Delhi

South
DELHI
110029
India 
Phone  9818829408  
Fax    
Email  tanmayadav@icloud.com  
 
Details of Contact Person
Scientific Query  
Name  Tanmay Yadav 
Designation  PG Resident 
Affiliation  Vardhman Mahavir Medical College and Safdarjung Hospital 
Address  Department of Anaesthesia and Intensive Care, Main OT Building, Vardhman Mahavir Medical College and Safdarjung Hospital, Ansari Nagar East, New Delhi

South
DELHI
110029
India 
Phone  9818829408  
Fax    
Email  tanmayadav@icloud.com  
 
Details of Contact Person
Public Query  
Name  Tanmay Yadav 
Designation  PG Resident 
Affiliation  Vardhman Mahavir Medical College and Safdarjung Hospital 
Address  Department of Anaesthesia and Intensive Care, Main OT Building, Vardhman Mahavir Medical College and Safdarjung Hospital, Ansari Nagar East, New Delhi

South
DELHI
110029
India 
Phone  9818829408  
Fax    
Email  tanmayadav@icloud.com  
 
Source of Monetary or Material Support  
Department of Anaesthesia and Intensive Care, Main OT Building, Vardhman Mahavir Medical College and Safdarjung Hospital, Ansari Nagar East, New Delhi-29 
 
Primary Sponsor  
Name  Department of Anaesthesia and Intensive Care 
Address  Department of Anaesthesia and Intensive Care, Main OT Building, Vardhman Mahavir Medical College and Safdarjung Hospital, Ansari Nagar East, New Delhi 
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 Meenakshi Kumar  Vardhman Mahavir Medical College and Safdarjung Hospital  General Surgery OT, Main OT/ New Emergency Building OT, Department of Anaesthesia and Intensive Care, Vardhman Mahavir Medical College and Safdarjung Hospital, Ansari Nagar East, New Delhi
South
DELHI 		 9899689829

drmeenakshi86@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: R112||Nausea with vomiting, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Dexmedetomidine  Intravenous infusion of Dexmedetomidine 0.5 mcg/kg (diluted to 10 mL with Normal Saline) over 10 minutes just before incision 
Comparator Agent  Dexmedetomidine-Dexamethasone  Intravenous infusion of Dexmedetomidine 0.5 mcg/kg + IV Dexamethasone 4 mg (diluted to 10 mL with Normal Saline) over 10 minutes just before incision 
Comparator Agent  Normal Saline  Intravenous infusion of Normal Saline 10 mL over 10 minutes just before incision 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  ASA physical status I/II.
Patients undergoing abdominal surgeries under general anaesthesia. 
 
ExclusionCriteria 
Details  Patients with previous history of post-operative nausea and vomiting, abdominal surgery, cardiovascular or cerebrovascular comorbidities, diabetes mellitus.
Patients with history of treatment with antiemetic or glucocorticoids.
Patients with BMI>30 kg/m2. 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Nausea
Incidence and frequency of vomiting 		 End of surgery
1 hour post-op
3 hour post-op
6 hour post-op
9 hour post-op
12 hour post-op
24 hour post-op 
 
Secondary Outcome  
Outcome  TimePoints 
Sedation  End of surgery
1 hour post-op
3 hour post-op
6 hour post-op
9 hour post-op
12 hour post-op
24 hour post-op 
Pain  End of surgery
1 hour post-op
3 hour post-op
6 hour post-op
9 hour post-op
12 hour post-op
24 hour post-op 
 
Target Sample Size   Total Sample Size="75"
Sample Size from India="75" 
Final Enrollment numbers achieved (Total)= "75"
Final Enrollment numbers achieved (India)="75" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   02/08/2021 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 23/11/2021 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
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
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Anyone

  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 [tanmayadav@icloud.com].

  6. For how long will this data be available start date provided 21-08-2022 and end date provided 21-07-2072?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary
Modification(s)  		 This is a prospective and interventional randomised comparative study to compare the effect of IV Dexmedetomidine with IV Dexmedetomidine-Dexamethasone combination with Normal Saline as control in preventing PONV in patients following abdominal surgeries under general anaesthesia using a Numerical Rating Scale in 75 patients of ASA physical status I/II of either gender of 18-60 years of age. The primary outcome measured will be incidence/frequency/severity of Nausea and incidence/frequency of Vomiting at regular time intervals post-op for up to 24 hours. The secondary outcomes measured will be post-op sedation using Ramsay Sedation Scale and post-op pain using Visual Analog Scale. 
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