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CTRI Number  CTRI/2023/08/056491 [Registered on: 14/08/2023] Trial Registered Prospectively
Last Modified On: 04/08/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia
Preventive 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A study comparing two groups of patients undergoing bilateral total knee replacement one receiving only injection dexamethasone and other receiving injection levosulpiride with injection dexamethasone to assess the effect for post operative nausea and vomiting prophylaxis. 
Scientific Title of Study   To assess the efficacy of addition of intravenous levosulpiride to dexamethasone as prophylaxis for PONV in patients undergoing B/L TKR: a prospective, randomized, double blinded, controlled 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  Mansimrat Singh 
Designation  post graduate resident 
Affiliation  Ivy hospital and health institute of life sciences 
Address  Department of Anesthesiology Ivy hospital and health institute of life sciences

Chandigarh
CHANDIGARH
160071
India 
Phone  7696729874  
Fax    
Email  drmansimrat@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sunny Rupal 
Designation  Consultant Anaesthesiologist 
Affiliation  Ivy hospital and health institute of life sciences 
Address  Department of Anesthesiology Ivy hospital and health institute of life sciences

Chandigarh
CHANDIGARH
160071
India 
Phone  9814359333  
Fax    
Email  sunnyrupal@gmail.com  
 
Details of Contact Person
Public Query  
Name  Mansimrat Singh 
Designation  post graduate resident 
Affiliation  Ivy hospital and health institute of life sciences 
Address  Department of Anesthesiology Ivy hospital and health institute of life sciences

Chandigarh
CHANDIGARH
160071
India 
Phone  7696729874  
Fax    
Email  drmansimrat@gmail.com  
 
Source of Monetary or Material Support  
Ivy Hospital and health institute of life sciences Sector 71 Mohali Punjab India 160071 
 
Primary Sponsor  
Name  Dr Sunny Rupal 
Address  Department of Anesthesiology Ivy hospital and health institute of life sciences Mohali Punjab India 160071 
Type of Sponsor  Other [Self] 
 
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 Mansimrat Singh  Ivy hospital and health institute of life sciences Mohali 160071  Ortho Operation Theatre Department of Anesthesiology Ivy hospital and health institute of life sciences 160071
Chandigarh
CHANDIGARH 		 7696729874

drmansimrat@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee Ivy Hospital Mohali  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M170||Bilateral primary osteoarthritis of knee, (2) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Injection dexamethasone  Injection dexamethasone 8 mg intravenously alone will be given one time 30 minutes after induction of anesthesia for post operative nausea vomiting prophylaxis and duration of intervention will be till 120 minutes and observation in post operative period will be done for 24 hours  
Intervention  Injection Levosulpiride  Injection Levosulpiride 25mg intravenously along with injection dexamethasone 8mg intravenously will be given one time 30 minutes after induction of anesthesia for post operative nausea vomiting prophylaxis and duration of intervention will be till 120 minutes and observation in post operative period will be done for 24 hours  
 
Inclusion Criteria  
Age From  50.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1. Patients scheduled for bilateral knee replacement surgery of ASA grade 1 and 2 , for degenerative joint disease.
2. Patients with APFEL score of at least 1 or more. 
 
ExclusionCriteria 
Details  ASA III, IV patients with severe illness
2. Patients with history of severe valular heart disease, vascular or conduction abnormalities
3. Known history of allergy to the study drugs
4. Any contraindication to spinal anesthesia or failure of spinal anesthesia necessitating general anesthesia
5. Patients with neurologic or cognitive disorders/ non cooperative patients/ patients with psychosis.
6. Patients with poor glycemic control HBA1c >8.
7. Severe hepatic or renal dysfunction
8. Intake of anti-emetics or steroids within last 24 hours of surgery
9. Patient’s refusal 
 
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 
Incidence of PONV
Incidence of nausea
Incidence of vomiting
2. Complete response of study drug (no nausea or vomiting or need of rescue drugs) 		 Till 24 hours 
 
Secondary Outcome  
Outcome  TimePoints 
Time of onset
Time of severity & duration of PONV
Severity of nausea
Severity of vomiting
Number of rescue antiemetic drugs requirements
Pain assessment
Side effects if any 		 Till 24 Hours 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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 2 
Date of First Enrollment (India)   15/09/2023 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  15/09/2023 
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 Yet Recruiting 
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 - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) - 

  6. For how long will this data be available start date provided 01-07-2023 and end date provided 31-01-2025?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Total knee Arthroplasty remains one of the most commonly performed major orthopedic procedures. The number of procedures in most countries has increased rapidly over the past decade. The incidence of postoperative nausea and vomiting in patients undergoing Arthroplasty is high if not given any antiemetics. We will assess the efficacy of addition of intravenous levosulpiride to dexamethasone as prophylaxis for post operative nausea vomiting in patients undergoing Bilateral total knee replacement in a prospective, randomized, double blind manner. We will be having 100 patients with 50 in each group both male and female patients and excluding patients with history of anaphylaxis or allergy to the study drugs and patients refusing for consent etc.

 
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