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CTRI Number  CTRI/2023/04/051958 [Registered on: 25/04/2023] Trial Registered Prospectively
Last Modified On: 24/04/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Evaluating dexamethasone vs dexmedetomidine in preventing nausea and vomiting in post-operative period in patients undergoing laparoscopic surgery under general aneasthesia. 
Scientific Title of Study   A randomized comparative control study on effects of dexmedetomidine versus dexamethasone on the incidence of postoperative nausea and vomiting in patients undergoing laparoscopic surgery under general anaesthesia. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrSuchana Maji 
Designation  Junior Resident  
Affiliation  Subharti Medical College and Hospital 
Address  Department of anaesthesiology Room no:7 Begum Hazrat Mahal Girls Hostel Subharti Medical College and Hospital Meerut Uttar Pradesh

Meerut
UTTAR PRADESH
250001
India 
Phone  9472212523  
Fax    
Email  suchana.majinn@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  Dr HS Minhas 
Designation  Professor 
Affiliation  Subharti Medical College and Hospital 
Address  Subharti Medical College and Hospital Department of Anaesthesiology. Meerut Uttar Pradesh

Meerut
UTTAR PRADESH
250001
India 
Phone  9472212523  
Fax    
Email  hsminhas28@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  DrSuchana Maji 
Designation  Junior Resident  
Affiliation  Subharti Medical College and Hospital 
Address  Department Of Anaesthesiology Room no:7 Begum Hazrat Mahal Girls Hostel Subharti Medical College and Hospital Meerut Uttar Pradesh

Meerut
UTTAR PRADESH
250001
India 
Phone  9472212523  
Fax    
Email  suchana.majinn@yahoo.co.in  
 
Source of Monetary or Material Support  
Subharti Medical College And Hospital Meerut Uttar Pradesh India 
 
Primary Sponsor  
Name  Suchana Maji 
Address  Department Of Anaesthesiology Room No:7 Begum Hazrat Mahal Girls Hostel Subharti Medical College and Hospital Meerut Uttar Pradesh 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
Subharti Medical College  Subharti Puram, NH-58, Delhi Haridwar Bypass Road,Uttar Pradesh 250005 Meerut Uttar Pradesh 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Suchana Maji  Subharti Medical College and Hospital  Department Of Anaesthesiology 2nd Floor Subharti Puram,NH-58,Delhi Haridwar Bypass Road,Uttar Pradesh 250005 Meerut Uttar Pradesh
Meerut
UTTAR PRADESH 		 9472212523

suchana.majinn@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
UNIVERSITY ETHICS COMMITTEE(MEDICAL),SWAMI VIVEKANAND SUBHARTI UNIVERSITY  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Intravenous Dexamethasone.  Patients allocated in the group will receive intravenous Inj. Dexamethasone in the dosage 8mg in 100ml normal saline over 10minutes, 5minutes before induction of anaesthesia. 
Intervention  Intravenous Dexmedetomidine.  patient allocated in the group will receive intravenous Inj. Dexmedetomidine in the dosage of 1 microgram/kilogram of bodyweight in 100ml normal saline over 10minutes, 5minutes before induction of anaesthesia 
Comparator Agent  Intravenous Normal Saline  patients allocated in the group will receive 100ml normal saline intravenously over 10 minutes, 5minutes before induction of anaesthesia. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients of ASA physical status I and II, both gender in the mentioned age group who will give written informed consent. 
 
ExclusionCriteria 
Details  Patients with ASA physical status III of greater.
Severe cardiorespiratory,hepatic,renal,neurological or endocrinal disease.
Bradycardia(Heart Rate<60bpm).
Pregnant and lactating women.
Obesity(BMI>30kg/m2).
Diabetes mellitus.
Patientswith known hypersensivity of drug allergies.
Patients who had taken H2 antagonists,antiemetic or psychoactive medication.
Nausea, retching,or vomiting within 48hours before surgery.
History of Motion sickness.
Patients who refuse to participate in the study.
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To evaluate and compare complete response to and/or incidence of Post operative nausea and vomiting with dexmedetomidine and dexamethasone seperately.  Baseline
Before Administration Of Drug
After administration of Drug
During Intubation
After Intubation
45 mins Intraoperatively
At the end of Surgery
15 minutes postoperatively
2 hours postoperatively
6 hours postoperatively
12 hours postoperatively 
 
Secondary Outcome  
Outcome  TimePoints 
To compare and evaluate incidence of rescue antiemetic used with dexmedetomidine and dexamethasone.
To compare and evaluate side effects of dexmedetomidine and dexamethasone.
To compare and evaluate patient satisfaction with Post-opeartive Nausea and vomiting. 		 Patients satisfaction score will be recorded 12 hours post-opearatively. 
 
Target Sample Size   Total Sample Size="105"
Sample Size from India="105" 
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)   08/05/2023 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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 - Clinical Study Report

  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 [suchana.majinn@yahoo.co.in].

  6. For how long will this data be available start date provided 15-04-2023 and end date provided 20-12-2026?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   This study is a randomized,double blinded, parallel group, single centre trial evaluating and comparing the efficacy of intravenous dexmethasone and intravenous dexmedetomidine on incidence of post opearative nausea and vomiting in patients undergoing laproscopic surgeries under general anaesthesia. the primary outcome will be to evaluate and compare complete response to and/or incidence of Post operative nausea and vomiting with dexmedetomidine and dexamethasone seperately. secondary outcomes will be to compare and evaluate incidence of rescue antiemetic used with dexmedetomidine and dexamethasone,to compare and evaluate side effects of dexmedetomidine and dexamethasone,to compare and evaluate patient satisfaction with Post-opeartive Nausea and vomiting. 
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