| 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
|
|
|
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
|
|
|
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
|
|
|
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. |