| CTRI Number |
CTRI/2025/06/089638 [Registered on: 26/06/2025] Trial Registered Prospectively |
| Last Modified On: |
12/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
To study how a combination of two medicines—lidocaine and ketamine—can help control the rise in blood pressure and heart rate that usually happens during certain stressful moments in open-heart surgery, like inserting the breathing tube, making the first cut, and opening the chest. |
|
Scientific Title of Study
|
To evaluate the effect of combination of lidocaine and ketamine infusion on attenuation of hemodynamic response to intubation,skin incision and sternotomy in open adult valvular heart surgeries.A double blinded randomized controlled 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 |
M Mahendra Naik |
| Designation |
Post graduate |
| Affiliation |
AIIMS RAIPUR |
| Address |
AIIMS RAIPUR, GREAT eastern road, opposite Gurudwara, Tatibandh Raipur, Chhattisgarh,
Raipur
CHHATTISGARH
492099
India |
| Phone |
9502355152 |
| Fax |
|
| Email |
mudemahendranaik@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Jitendra kalbande |
| Designation |
Assistant professor |
| Affiliation |
AIIMS RAIPUR |
| Address |
AIIMS RAIPUR, GREAT eastern road, opposite Gurudwara, Tatibandh Raipur, Chhattisgarh,
Raipur
CHHATTISGARH
492099
India |
| Phone |
9096447683 |
| Fax |
|
| Email |
drjitu222@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Jitendra kalbande |
| Designation |
Assistant professor |
| Affiliation |
AIIMS RAIPUR |
| Address |
AIIMS RAIPUR, GREAT eastern road, opposite Gurudwara, Tatibandh Raipur, Chhattisgarh,
Raipur
CHHATTISGARH
492099
India |
| Phone |
9096447683 |
| Fax |
|
| Email |
drjitu222@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Tatiband, GE road, Raipur , Chhattisgarh. 492099.INDIA |
|
|
Primary Sponsor
|
| Name |
Nil |
| Address |
Nil |
| Type of Sponsor |
Other [] |
|
|
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 M Mahendra Naik |
AIIMS Raipur |
Department of Anesthesiology, CTVS OT, Super speciality OT, 4th floor , B BLOCK, Raipur, Chattisgarh.
Raipur
CHHATTISGARH |
9502355152
mude.mahendranaik@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute ethics committee AIIMS Raipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, , (1) ICD-10 Condition: I05-I09||Chronic rheumatic heart diseases, (2) ICD-10 Condition: I083||Combined rheumatic disorders of mitral, aortic and tricuspid valves, (3) ICD-10 Condition: I083||Combined rheumatic disorders of mitral, aortic and tricuspid valves, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Lignocaine 1.5 mg/kg and Ketamine 0.2 mg/kg |
Lignocaine 1.5 mg/kg and Ketamine 0.2 mg/kg given bolus initially and continued infusion until 10 Minutes after sternotomy |
| Comparator Agent |
Placebo |
Plane normal saline will be given |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients aged between 18 to 75 years, scheduled for elective open valvular heart surgery
Both male and female patients will be included
Patients with left ventricular ejection fraction (LVEF) greater than 40%, assessed by echocardiography within 1 week prior to surgery
Patients undergoing elective open valvular heart surgery via median sternotomy
American Society of Anesthesiologists (ASA) physical status classification Grade II or III
Patients who provide written informed consent |
|
| ExclusionCriteria |
| Details |
Patient refusal
Allergy to the study drug
History of opioid abuse
History of any addiction
Cognitive dysfunction
Raised intracranial pressure |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in heart rate, blood pressure, during intubation, skin incision, and sternotomy |
At the time of intubation, 5 minutes after intubation, at the time of skin incision,sternotomy,5minutes after sternotomy |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Total dose of Propofol and Fentanyl required |
Intubation, skin incision , and sternotomy |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
07/07/2025 |
| Date of Study Completion (India) |
21/10/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Hemodynamic stability is crucial during cardiac surgery to ensure adequate organ perfusion and improve outcomes. Surgical stimuli such as laryngoscopy, intubation, skin incision, and sternotomy can provoke significant sympathetic responses, leading to increased heart rate and blood pressure—potentially harmful in patients with heart disease. Conventional drugs have limited success in attenuating these responses. Lidocaine and ketamine, due to their analgesic, anti-inflammatory, and cardiovascular properties, may help stabilize intraoperative hemodynamics and reduce anesthetic requirements. However, limited data exist on their effects during open valvular heart surgeries. This study aims to evaluate their efficacy in blunting hemodynamic responses during such procedures. |