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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  
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 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  
Status 
Not Applicable 
 
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)

 
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