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CTRI Number  CTRI/2020/08/027031 [Registered on: 07/08/2020] Trial Registered Prospectively
Last Modified On: 06/08/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia
Preventive 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   comparison of two drugs for prevention of post operative nausea and vomiting 
Scientific Title of Study   To compare the efficacy of palonosetron dexamethasone combination with palonosetron and dexamethasone alone for prevention of post operative nausea and vomiting in patients undergoing laparoscopic cholecystectomy 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Anita Kumari 
Designation  Professor 
Affiliation  Sri Guru Ram Das Institute of Medical Sciences and Research 
Address  Department of Anaesthesia, SGRDIMSAR, Amritsar
Department of Anaesthesia, SGRDIMSAR, Amritsar
Amritsar
PUNJAB
143501
India 
Phone  9815632909  
Fax    
Email  kumarianitadr1@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Anita Kumari 
Designation  Professor 
Affiliation  SGRDIMSAR 
Address  Department of Anaesthesia, SGRDIMSAR, Amritsar
Department of Anaesthesia, SGRDIMSAR, Amritsar

PUNJAB
143501
India 
Phone  9815632909  
Fax    
Email  kumarianitadr1@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Chanpreet Kaur 
Designation  Junior Resident 
Affiliation  SGRDIMSAR 
Address  Department of Anaesthesia, SGRDIMSAR, Amritsar
Department of Anaesthesia, SGRDIMSAR, Amritsar
Amritsar
PUNJAB
143501
India 
Phone  9646457241  
Fax    
Email  nchanpreet@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesia, SGRDIMSAR, Amritsar 
 
Primary Sponsor  
Name  NA 
Address  NA 
Type of Sponsor  Other [] 
 
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 Anita Kumari  SGRDIMSAR  Operation Theater SGRDIMSAR
Amritsar
PUNJAB 		 9815632909

kumarianitadr1@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SGRD ethical committee  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,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  inj.palonosetron and inj. dexamethasone   Group A will receive 0.075 mg inj. palonosetron along with 8mg of inj. dexamethasone Group B will receive 0.075 mg of inj. palonosetron Group C will receive 8 mg of inj. dexamethasone  
Comparator Agent  palonosetron and dexamethasone   To compare the efficacy of palonosetron, dexamethasone and their combination for prevention of post operative nausea and vomiting in patients undergoing laparoscopic cholecystectomy 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients belonging to ASA grade 1 and 2.
Patients posted for elective laparoscopic cholecystectomies under general anaesthesia.
 
 
ExclusionCriteria 
Details  Patient refusal.
Patients with known hypersensitivity or contraindications to study drugs.
Patients posted for emergency surgery.
Patients with history of nausea, vomiting or retching in 24 hours before anaesthesia.
5. Patients receiving antiemetic therapy in 24 hours before surgery.
6. Patients with history of motion sickness.
7. Pregnant female.
 
 
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 
postoperative nausea and vomiting in patients undergoing elective laparoscopic cholecystectomies under general anaesthesia.

 		 one hourly for the first four hours then at 8, 12, 18,24,30,36,42,48 hours 
 
Secondary Outcome  
Outcome  TimePoints 
NA  NA 
 
Target Sample Size   Total Sample Size="75"
Sample Size from India="75" 
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)   09/08/2020 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NA 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Post operative nausea and vomiting is highly distressing and unpleasant symptom. Inj. Palonosetron and inj. dexamethasone are effective antiemetics with minimal side effect profile. This study compares the efficacy of inj. palonosetron or dexamethasone alone and their combination (inj. palonosetron+ inj. dexamethasone) for prevention of post operative nausea and vomiting after laparoscopic cholecystectomy. The study will be done on 75 adult patients of ASA I and ASA II aged 18-60 years. They will be allocated into three groups of 25 each and will receive either of three treatment regimens .075mg palonosetron+8mg dexamethasone, 0.075 mg inj. palonosetron and 8mg inj. dexamethasone intravenously in group A, B and C respectively. Nausea, retching, vomiting, pain will be recorded 1 hourly for 4 hours and then 4 hourly till next 12 hours and 6 hourly thereafter till 48 hours.

 
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