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CTRI Number  CTRI/2024/09/073695 [Registered on: 10/09/2024] Trial Registered Prospectively
Last Modified On: 03/09/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia
Preventive
Process of Care Changes 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Compare effect of Granisetron vs Lignocain in allevating the pain induced by propofol in patients undergoing general anaesthesia 
Scientific Title of Study   A comparative study of clinical efficacy of pretreatment between intravenous Granisetron and intravenous Lignocaine to allaevate pain on Propofol injection during general anaesthesia.  
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 Nitin S. Kunnoor 
Designation  Resident Doctor 
Affiliation  Mahadevappa Rampure Medical College and Hospital  
Address  Mahadevappa Rampure Medical College and Hospital, Department of Anesthesia, 1st floor, Room 1, Sedam Road, Kalaburagi

Gulbarga
KARNATAKA
585105
India 
Phone  9964030090  
Fax    
Email  drnitinskunnoor23@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Pratima B Patil  
Designation  Professor, Anaesthesiology 
Affiliation  Mahadevappa Rampure Medical College and Hospital  
Address  Mahadevappa Rampure Medical College and Hospital, Department of Anesthesia, 1st floor, Room 1, Sedam Road, Kalaburagi

Gulbarga
KARNATAKA
585105
India 
Phone  9972166344  
Fax    
Email  pratimab1975@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Nitin S Kunnoor 
Designation  Resident Doctor 
Affiliation  Mahadevappa Rampure Medical College and Hospital  
Address  Mahadevappa Rampure Medical College and Hospital, Department of Anesthesia, 1st floor, Room 1, Sedam Road, Kalaburagi

Gulbarga
KARNATAKA
585105
India 
Phone  9964030090  
Fax    
Email  drnitinskunnoor23@gmail.com  
 
Source of Monetary or Material Support  
Nil 
 
Primary Sponsor  
Name  Dr Nitin S Kunnoor 
Address  Mahadevappa Rampure Medical College and Hospital, Department of Anesthesia, 1st floor, Room 1, Sedam Road, Kalaburagi 
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 Nitin S Kunnoor  Mahadevappa Rampure Medical College and Hospital, Kalaburagi   Mahadevappa Rampure Medical College and Hospital, Department of Anesthesia, 1st floor, Room 1, Sedam Road, Kalaburagi
Gulbarga
KARNATAKA 
9964030090

drnitinskunnoor23@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Mahadevappa Rampure Medical College Kalaburagi   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 
Intervention  G group - Granisetron 2mg/2ml IV   Granisetron 2mg/2ml IV injection given prior to injection propofol induction agent 
Comparator Agent  L group - Lignocaine 40mg/2ml IV   Injection lignocaine 40mg/2ml IV given before injection propofol induction agent  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Participants scheduled for elective surgeries under General Anaesthesia (GA)
2. Participants with American Society of Anaesthesiologists (ASA) physical status Grade I & II
3. Age 18-60 years, weighing between 40 – 80 kgs of all genders 
 
ExclusionCriteria 
Details  1. Emergency surgeries under GA
2. Participantswith history of allergy to specified drugs and its congeners in study.
3. Participants received any sedatives, analgesics within last 12 hours before procedure
4. Pregnant and lactating women
5. Participants with communication problems & Psychiatric Disorder 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
intravenous granisetron, being a potent 5HT3antagonist might decrease pain (by 50%) caused by iv injection of propofol   8 hours 
 
Secondary Outcome  
Outcome  TimePoints 
Reduction in post operative nausea and vomiting up to 8 hours
Haemodynamic changes ; ADR  
8 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   N/A 
Date of First Enrollment (India)   23/09/2024 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Propofol, a non-opioid intravenous anaesthetic agent, is frequently used as an inducing agent in general anaesthesia. Direct irritant effect of propofol on vein and kinin cascade release causes the pain in 30%-90% of the patients during intravenous injection (IV) though its pH and osmolality are close to those of blood.1,2

The American anaesthesiogist had ranked pain induced by propofol injection as the 7th most common problem of current clinical anaesthesiology.3 Various methods have been tried for attenuating pain during i.v. injection of propofol. Non pharmacological methods like injection in a fast running i.v. fluid, injection in a larger vein, diluting with 10% intra lipid, cooling propofol to 4°C have been tried with little success.4,5

Amongst pharmacological methods pre-treatment with several agents have been tried like lignocaine, fentanyl, ketamine, dexamethasone, dexmetomidine, clonidine, ketoprofen, tramadol.6-9

But, Neither a single agent nor any method is found till date that has 100% efficacy to relieve the pain of propofol injection. Pretreatment with IV lignocaine has proven to be efficacious, by reducing propofol induced pain by nearly 50-60% but is associated with paresthesia that lasts far beyond the duration of anesthesia, sensations of numbness, swelling, tingling, and itching.2

Injection pain is not only a cause of concern but, Post Operative Nausea and Vomiting (PONV) incidences are also high in patients undergoing general surgeries.10, 11 Other peri-operative factors like haemodynamic stability, analgesia andreduced adverse effects to drugs administered are subject of interest to anesthesiologists for better patient care who undergo surgery under general anaesthesia

In this context, new pharmacological agents like 5HT3 receptor antagonists (ondansetron) have been tried to preventpain on IV propofol injection along with added benefit of preventing PONV, analgesia and reduced parasthesia.12Granisetron, a higher congener of ondansetron, has betterantiemetic effect. The preliminary evidence suggests that granisetron is effective in preventing pain on IV propofol administration by multifaceted activities such as a sodium channel blocker and μ opioid agonist apart from 5HT3 receptor antagonist activity. 10,13,14

 

In our practice, 5HT3antagonists like ondensetron and granisetronis routinely administeredas pre-medication to prevent post-operative nausea and vomiting in patients undergoing surgeries under general anaesthesia. 

Hence, in this study we want to compare the analgesic efficacy between IV granisetron (2mg in 2 ml) and IV lignocaine 2% (40mg in 2 ml) in allevating pain on IV propofol injection.

 
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