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CTRI Number  CTRI/2025/09/094527 [Registered on: 10/09/2025] Trial Registered Prospectively
Last Modified On: 10/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Comparison between Metoclopramide and Lignocaine,to reduce pain during propofol induction. 
Scientific Title of Study   Efficacy of Metoclopramide versus Lignocaine in reducing pain on propofol induction: A randomized controlled trial 
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 Renduchintala Sravya Sunanda 
Designation  Post Grduate Trainee 
Affiliation  Kalinga Institute of Medical Sciences 
Address  Department of Anaesthesiology Kalinga Institute of Medical Sciences KIIT deemed to be university

Khordha
ORISSA
751024
India 
Phone  8247059575  
Fax    
Email  sravyasunanda09@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Manoj Kumar Muni 
Designation  Professor 
Affiliation  Kalinga Institute of Medical Sciences 
Address  Department of Anaesthesiology Kalinga Institute of Medical Sciences

Khordha
ORISSA
751024
India 
Phone  7853940106  
Fax    
Email  manoj.muni@kims.ac.in  
 
Details of Contact Person
Public Query  
Name  Dr Manoj Kumar Muni 
Designation  Professor 
Affiliation  Kalinga Institute of Medical Sciences 
Address  Department of Anaesthesiology Kalinga Institute of Medical Sciences

Khordha
ORISSA
751024
India 
Phone  7853940106  
Fax    
Email  manoj.muni@kims.ac.in  
 
Source of Monetary or Material Support  
Kalinga Institute Of Medical Sciences Bhubaneswar ,Khordha, Odisha India PIN 751024  
 
Primary Sponsor  
Name  Renduchintala Sravya Sunanda 
Address  Department of Anaesthesiology KIIT deemed to be university Bhubaneswar, PIN:751024 
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 Manoj Kumar Muni  Pradyumna Bal Memorial, Kalinga Institute of Medical Sciences  Department of Anaesthesiology Kalinga Institute of Medical Sciences Bhubaneswar 751024
Khordha
ORISSA 		 7853940106

manoj.muni@kims.ac.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE KALINGA INSTITUTE OF MEDICAL SCIENCES  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 
Comparator Agent  Lignocaine  Group B will be receiving 2ml of 40 mg lignocaine intravenously (preservative free) over 10 seconds 
Intervention  Metoclopramide  Group A will be receiving 2ml of 10 mg of metoclopramide intravenously over 10 seconds  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1.Patients posted for elective surgeries under general anaesthesia
2.American Society of Anaesthesiologists(ASA) physical status 1 and 2
3.18 guage cannula on dorsum of hand 
 
ExclusionCriteria 
Details  1.Pregnant females
2. Patients posted for emergency procedures
3.Patients allergic to study drugs
4.Patients requiring rapid sequence intubation
5.Patients with extrapyramidal symptoms 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To evaluate for reduction of pain on propofol injection with metoclopramide versus lignocaine as pretreatment, using verbal rating scale  15 seconds 
 
Secondary Outcome  
Outcome  TimePoints 
To observe for adverse effects of the study drugs like itching & swelling, at the site of administration.  Patients will be followed up to 6 hours.  
 
Target Sample Size   Total Sample Size="158"
Sample Size from India="158" 
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 2 
Date of First Enrollment (India)   01/10/2025 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Open to Recruitment 
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   Propofol is the most commonly used intravenous anaesthetic agent, widely employed for the induction of general anaesthesia and for sedation during short procedures.

Metoclopramide as a prokinetic agent with antiemetic properties is a safe and effective option used before induction of anaesthesia .The pain-relieving properties of metoclopramide could be explained by the fact that serotonin/5-hydroxytryptamine (5-HT) is a biological amine in the brain and spinal cord . Studies indicate that 5-HT3 antagonists have sodium channel blocking action 15 times greater than that of lignocaine.

Lignocaine has been used to prevent propofol pain on injection, over the years.

We hypothesize that there will be a better reduction of pain on propofol induction with the use of metoclopramide as pretreatment compared to lignocaine.
 
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