CTRI Number |
CTRI/2022/11/047602 [Registered on: 24/11/2022] Trial Registered Prospectively |
Last Modified On: |
21/11/2022 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Drug |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
Use of multiple drugs to reduce pain of propofol injection |
Scientific Title of Study
|
To compare the effect of Lignocaine, Ondansetron, Ramosetron and Metoclopramide in attenuation of propofol induced pain during the induction of anaesthesia |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Srinivasa VY |
Designation |
Professor |
Affiliation |
Mysore Medical College and Research Institute |
Address |
No 302, Sripooja, Moow and CSI Layout High Tension Road, C and D block, Kuvempunagar, Mysuru, Karnataka Professor, Department of Anaesthesiology, KR Hospital, Mysore Medical College and Research Institute, Mysuru. Mysore KARNATAKA 570023 India |
Phone |
9448165082 |
Fax |
|
Email |
drsrinivasvy@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Srinivasa VY |
Designation |
Professor |
Affiliation |
Mysore Medical College and Research Institute |
Address |
No 302, Sripooja, Moow and CSI Layout High Tension Road, C and D block, Kuvempunagar, Mysuru, Karnataka Professor, Department of Anaesthesiology, KR Hospital, Mysore Medical College and Research Institute, Mysuru. Mysore KARNATAKA 570023 India |
Phone |
9448165082 |
Fax |
|
Email |
drsrinivasvy@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Syeda Gowsia Azhar |
Designation |
Post graduate student |
Affiliation |
Mysore Medical College and Research Institute |
Address |
No 49, 6th cross, Gokulam 1st stage, Mysuru, Karnataka Post graduate student, Department of Anaesthesiology, KR Hospital, Mysore Medical College and Research Institute, Mysuru. Mysore KARNATAKA 570002 India |
Phone |
9886567384 |
Fax |
|
Email |
syeeeda.azhar@gmail.com |
|
Source of Monetary or Material Support
|
Mysore medical College and Research Institute |
|
Primary Sponsor
|
Name |
Mysore Medical college and Research Institute |
Address |
Irwin road Mysore |
Type of Sponsor |
Government medical college |
|
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 VY Srinivas |
KR Hospital and Cheluvamba Hospital operation theatre |
Mysore Medical College and research Institute, Irwin Road, Mysore Mysore KARNATAKA |
9448165082
drsrinivasvy@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethics Committee |
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 |
Comparator Agent |
intravenous lignocaine
|
Intravenous Lignocaine 40mg single dose duration of intervention is 30 seconds |
Intervention |
Intravenous metoclopramide |
Single dose of intravenous metoclopramide 10mg duration of intervention is 30 seconds |
Intervention |
Intravenous Ondansetron |
Single dose of intravenous ondansetron 4mg duration of intervention is 30 seconds |
Intervention |
intravenous ramosetron |
Single dose of intravenous ramosetron 0.3mg duration of intervention is 30 seconds |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
1. Patients undergoing elective surgeries under general anaesthesia.
2. Belonging to American Society of Anaesthesiologists (ASA) Physical status
I or II.
3. Patients who are willing to sign written informed consent form.
|
|
ExclusionCriteria |
Details |
1. Patients belonging to ASA III and IV physical status.
2. Patients with known cardiac disorders, other systemic disorders of lung and liver.
3. Pregnant patients
4. Patients for emergency procedures.
5. Those allergic to Propofol and study drugs
6. Those with history of motion sickness
7. History of post- operative nausea and vomiting
8. Patients in nasogastric tube and patients with difficult airway.
9. Patient refusal
10. History of taking any analgesic before surgery
11. Neurological deficit |
|
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 |
Attenuation of propofol induced pain during induction of anaesthesia. |
Pain is assessed at baseline, 5 seconds 10 seconds, 15 seconds, 20 seconds, 25 seconds and 30 seconds during induction of anaesthesia using propofol injection |
|
Secondary Outcome
|
Outcome |
TimePoints |
nil |
nil |
|
Target Sample Size
|
Total Sample Size="200" Sample Size from India="200"
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 4 |
Date of First Enrollment (India)
|
01/12/2022 |
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="0" Months="3" Days="10" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
Planned for future publication |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response (Others) -
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) - By mail
- For how long will this data be available start date provided 11-09-2023 and end date provided 10-03-2026?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
Brief Summary
|
Propofol, a short acting intravenous anaesthetic agent is used extensively because of its smooth induction and rapid recovery. It is the agent of choice for day care anaesthesia, total intravenous anaesthesia, for sedation in intensive care units, and as an agent for maintenance of anaesthesia. However, pain on intravenous injection is a major drawback of propofol. Pain is acknowledged reaction of propofol administration. ..Propofol can directly inflame the skin, mucous membranes and venous intima and can instantly lead to nociceptor and free nerve ending stimulation. Pain post propofol administration can be disquieting and is known to affect between 28% and 90% of patients. Injection pain is associated with the concentration of the aqueous free propofol. It has been attributed to the contact between the aqueous phase and the venous intima. It has been advocated that propofol causes release of bradykinin via activation of the kallikrein-kinin system, leading to venous dilation and hyperpermeability, enhancing the contact between the aqueous phase and free nerve endings, resulting in deferred pain within 10-20 seconds. Various pharmacological (e.g., pretreatment with lignocaine, ondansetron, granisetron, palonosetron, magnesium sulphate, nitroglycerine, ramosetron, metoclopramide, nitroglycerine, diluting propofol with 5% dextrose and using medium and long chain triglycerides) and non-pharmacological (e.g., injecting propofol into large vein, cooling of propofol, warming of propofol, adding saline to propofol or varying the rate of propofol infusion) methods have been used with variable results and the research for the ideal agent to decrease pain on propofol injection is still going on. Pre-treatment with lignocaine with venous occlusion was found to decrease the incidence and severity of pain on injection of propofol. Lignocaine hydrochloride due to its membrane stabilising action along with blocking of sodium channels was well accepted. Ondansetron a 5HT3 antagonist, widely used as an antiemetic drug which has got a local anaesthetic property it is also used as pretreatment for alleviation of pain on propofol injection. Ramosetron is one of the potent 5HT3 receptor antagonist commonly used as an antiemetic and has been found to be effective in prevention of early Post operative nausea and vomiting compared to ondansetron. Metoclopramide shares structural and physicochemical properties with lignocaine and is a weak local anaesthetic. It has been shown to be as effective as lignocaine in reducing propofol injection pain. Considering this, the aim of present study is to compare effect of lignocaine, ondansetron, ramosetron and metoclopramide in attenuation of propofol induced pain during the induction of anaesthesia. |