| CTRI Number |
CTRI/2025/11/097306 [Registered on: 13/11/2025] Trial Registered Prospectively |
| Last Modified On: |
12/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study comparing Remifentanil and Lidocaine as interventions to control Blood Pressure and Heart Rate during Intubation in study participants, with the main outcome being how effectively they keep these vital signs stable |
|
Scientific Title of Study
|
Comparison of Remifentanil and Lidocaine in attenuation of haemodynamic responses during intubation in patients undergoing general anesthesia |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrChatrasapally Mohan Manikanta |
| Designation |
junior resident |
| Affiliation |
ESIC medical college |
| Address |
Department of Anesthesia,ESIC medical college,sanathnagar,hyderabad
Hyderabad
TELANGANA
500018
India |
| Phone |
9502870453 |
| Fax |
|
| Email |
ajaymohan453@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrRavichandra Dodawad |
| Designation |
Professor and HOD |
| Affiliation |
ESIC medical college |
| Address |
Department of Anesthesia ESIC medical college floor no 2 sanathnagar hyderabad
Hyderabad
TELANGANA
500018
India |
| Phone |
9986514152 |
| Fax |
|
| Email |
dr.ravichandra.dodawad@esic.nic.in |
|
Details of Contact Person
Public Query
|
| Name |
DrRavichandra Dodawad |
| Designation |
Professor and HOD |
| Affiliation |
ESIC medical college |
| Address |
Department of Anesthesia ESIC medical college floor no 2 sanathnagar hyderabad
Hyderabad
TELANGANA
500018
India |
| Phone |
9986514152 |
| Fax |
|
| Email |
dr.ravichandra.dodawad@esic.nic.in |
|
|
Source of Monetary or Material Support
|
| ESIC Medical college and Hospital, Sanathnagar, Hyderabad, Telangana, India, Pincode : 500018 |
|
|
Primary Sponsor
|
| Name |
ESIC Medical College and Hospital |
| Address |
DEPARTMENT OF ANAESTHESIA
ESIC Medical College and Hospital, Sanathnagar, Hyderabad, Telangana, India, Pincode : 500018
|
| 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 |
| DrRavichandra Dodawad |
ESIC Medical College and Hospital |
Room No 3021,
OT COMPLEX,
3rd floor
Department of Anaesthesia
Hyderabad
TELANGANA |
9986514152
rdodawad@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe |
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 |
INJ LIDOCAINE |
One dose of INJ LIDOCAINE 1mg/kg Intravenously injected 90 seconds before intubation |
| Intervention |
Injection REMIFENTANIL |
One dose of INJ REMIFENTANIL 1mcg/kg Intravenously will be injected 90 seconds before intubation |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA 1&2
Undergoing elective surgery under general anaesthesia |
|
| ExclusionCriteria |
| Details |
Known allergy to study drugs
History of cardiovascular disease
Patients on beta blockers or anti hypertensive medication
Difficult airway or anticipated difficult intubation
Emergency surgeries |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the increase of heart rate between two groups |
T1 - Baseline
T2 - 90 seconds after administration of study drug
T3 - 1 minute after intubation
T4 - 3 minutes after intubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Two record BP. |
T1-BASE LINE
T2-After 90 SECONDS
T3-1 MINUTE AFTER INTUBATION
T4-3 MINUTES AFTER INTUBATION |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
01/12/2025 |
| 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="1"
Months="6"
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response (Others) -
- For how long will this data be available start date provided 14-03-2027 and end date provided 14-03-2030?
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
|
Comparision of Remifentanil and Lidocaine in reducing heart rate during intubation by recording heart rate at beseline 90 seconds after administration of study drugs 1minute and 3 minutes after intubation by dividing patients into two groups who belongs to ASA1 and 2 classification after randomization by computer generated numbers and study drugs are prepared by anesthetist who was not involved in anesthesia. the drug will be administered to both groups. the heartrate and blood pressure will be recorded after intubation at given time points i.e after 1 and 3 minutes of intubation. the data will be recorded and statistically analysed. |