| CTRI Number |
CTRI/2025/07/089936 [Registered on: 01/07/2025] Trial Registered Prospectively |
| Last Modified On: |
01/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Surgical/Anesthesia |
| Study Design |
Non-randomized, Placebo Controlled Trial |
|
Public Title of Study
|
An observational study to examine and compare effects of four medications given before Propofol injection is Cold saline Lignocaine Cold saline plus Lignocaine and Normal saline for reducing pain during Propofol injection in patients undergoing general anaesthesia |
|
Scientific Title of Study
|
Comparative analysis of pain on Propofol injection with pretreatment using Cold saline Lignocaine Cold saline plus Lignocaine and Normal saline in patients undergoing general anaesthesia A Prospective Observational 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 |
Hrithika |
| Designation |
Postgraduate student |
| Affiliation |
Yenepoya School Of Allied Health Sciences |
| Address |
Department of Anaesthesia and OT Technology Yenepoya School of Allied Health Sciences Yenepoya (Deemed To Be University)
Derlakatte,Mangalore
Dakshina Kannada KARNATAKA 575018 India |
| Phone |
09972410470 |
| Fax |
|
| Email |
hrithikadevadiga@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Swathi Kumari K |
| Designation |
Assistant Professor (Department of Anaesthesiology) |
| Affiliation |
Yenepoya Medical College and Hospital |
| Address |
Department of Anaesthesiology Yenepoya Medical College
Yenepoya (Deemed To Be University) Derlakatte Mangalore
Dakshina Kannada KARNATAKA 575018 India |
| Phone |
7338555009 |
| Fax |
|
| Email |
hithabhandary@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Swathi Kumari K |
| Designation |
Assistant Professor (Department of Anaesthesiology) |
| Affiliation |
Yenepoya Medical College and Hospital |
| Address |
Department of Anaesthesiology
Yenepoya Medical College
Yenepoya (Deemed to be University) Deralakatte Mangalore
Dakshina Kannada KARNATAKA 575018 India |
| Phone |
7338555009 |
| Fax |
|
| Email |
hithabhandary@gmail.com |
|
|
Source of Monetary or Material Support
|
| Yenepoya Medical College Hospital, Yenepoya (Deemed to be university),Deralakatte, Mangalore, Dakshina Kannada, Karnataka, India-575018 |
|
|
Primary Sponsor
|
| Name |
Hrithika |
| Address |
Yenepoya School Of Allied Health Sciences Yenepoya (Deemed To Be University) Mudipu Campus Near Surya tech park Kayargoli Kurnad Post Bantwal 574153 |
| 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 Swathi Kumari K |
Yenepoya Medical College Hospital |
operation theatre complex and post operative ward 3rd and 6th floor, Department of Anaesthesiology, Derlakatte, Mangalore, 575018 Dakshina Kannada KARNATAKA |
7338555009
hithabhandary@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Yenepoya Ethics Committee-4 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Patients undergoing elective surgery under general anaesthesia, with ASA physical status I and II |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Cold Normal Saline (at 4 degree Celsius) |
Dose: 5ml
Route of administration: intravenous injection over 5 seconds
Frequency: Single Dose
|
| Intervention |
Cold Normal saline (at 4 degree Celsius) + Lignocaine hydrochloride injection 2% (IV use) |
Dose:5ml cold saline at 4 degree C + 60mg (3ml) lignocaine 2%
Route: Intravenous injection over 5 seconds
Frequency: Single dose
|
| Intervention |
Lignocaine Hydrochloride injection 2% (IV use) |
Dose:60 mg (3ml)
Route :Intravenous injection over 5 seconds
Frequency: Single dose
|
| Intervention |
Normal Saline |
Dose:5ml
Route: Intravenous injection over 5 seconds
Frequency: Single dose
|
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.The patient who are undergoing general anaesthesia and eligible cases during the study period are covered
2.American Society of Anaesthesiologist physical status (ASA PS) I and II
3.BMI 18-24 Kg/m2 |
|
| ExclusionCriteria |
| Details |
1.Allergy to study medication
2.Serious venous insufficiency
3.Pregnant/lactating women |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence and severity of pain on propofol injection in patients pretreated with cold saline, lignocaine, cold saline + lignocaine and normal saline using pain score |
pain score is taken Immediately after giving 5ml of propofol injection (within 5 to 10 seconds) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Post operative recall of pain on propofol injection in patients pretreated with cold saline, lignocaine, cold saline + lignocaine and normal saline |
post-operatively patient will grade pain using numerical rating scale when fully conscious within 1-2 hours |
|
|
Target Sample Size
|
Total Sample Size="132" Sample Size from India="132"
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)
|
14/07/2025 |
| 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="11" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 - NO
|
|
Brief Summary
|
In this study "COMPARATIVE ANALYSIS OF PAIN ON PROPOFOL INJECTION WITH PRETREATMENT USING COLD SALINE, LIGNOCAINE, COLD SALINE PLUS LIGNOCAINE AND NORMAL SALINE IN PATIENTS UNDERGOING GENERAL ANAESTHESIA: A PROSPECTIVE OBSERVATIONAL STUDY” This prospective observational study is designed to evaluate pain during propofol injection in patients pretreated with cold saline, lignocaine, cold saline plus lignocaine and normal saline, to compare the efficacy of pre-treatment methods: cold saline, lignocaine and their combination to normal saline in providing pain relief on propofol injection (POPI) during various surgeries under general anaesthesia (G.A) Attending anaesthesiologist will provide pretreatment and principal investigator will only observe and document the pain score The anaesthesia protocol will adhere to standard practices and anaesthesia will be provided by experienced anaesthesiologist. Monitoring will encompass standard parameters. A standard 20-gauge peripheral intravenous (IV) cannula will be placed into largest visible vein, preferably on dorsum of hand as standard practice to administer propofol. This study will include 132 participants of American Society of Anaesthesiologist physical Status (ASA PS) 1 or 2, of all genders in age group of 19-65 years undergoing GA will be enrolled in the study. Attending Anaesthesiologist will provide pretreatment as per patient posted for surgery under general anaesthesia, the patients will be assigned to one of the four pretreatment groups: In Group C-33 patients will receive 10ml cold saline at .Group L -33 patients will receive 3ml of lignocaine. Group CL- 33 patients will receive Cold saline plus lignocaine. In Group N- 33 patients will receive 10 ml of normal saline at room temperature, following pretreatment, patients will be given 5ml of propofol over 5 second. Soon after propofol injection, Principal investigator will ask the patient for any pain and signs of pain observed will be graded on pain score from none to severe. Principal investigator will record Heart rate before and after the propofol injection. After the surgery, patients will be shifted to the post-anesthesia care unit (PACU). Post-operative recall of pain on propofol injection will be assessed in the PACU by the principal investigator, once fully conscious, the patient will grade pain using the Numerical Rating Scale (NRS) |