| CTRI Number |
CTRI/2025/07/090446 [Registered on: 08/07/2025] Trial Registered Prospectively |
| Last Modified On: |
07/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Using intravenous and nebulized lignocaine before surgery to reduce the increase in blood pressure during laryngoscopy and intubation in women with severe preeclampsia undergoing a cesarean section. |
|
Scientific Title of Study
|
Efficacy of preoperative intravenous and nebulized lignocaine for attenuation of pressor response to laryngoscopy and intubation in severe preeclampsia undergoing lower segment cesarian section a randomized double blind study.
|
| Trial Acronym |
Randomized, parallel group trial |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rajendra Jhariya |
| Designation |
PG Resident |
| Affiliation |
Pt J N M Medical college Raipur |
| Address |
Department of Anesthesiology and pain medicine
Pt J N M Medical college Raipur Chhattisgarh
Raipur
CHHATTISGARH
492001
India |
| Phone |
07987255640 |
| Fax |
|
| Email |
rajendra.jhariya1996@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pratibha Jain Shah |
| Designation |
HOD and Professor |
| Affiliation |
Pt J N M Medical college Raipur |
| Address |
Department of Anesthesiology and pain medicine Pt J N M Medical college Raipur
Raipur
CHHATTISGARH
492001
India |
| Phone |
9827276620 |
| Fax |
|
| Email |
prati_jain@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pratibha Jain Shah |
| Designation |
HOD and Professor |
| Affiliation |
Pt J N M Medical college Raipur |
| Address |
Department of Anesthesiology and pain medicine Pt J N M Medical college Raipur
Raipur
CHHATTISGARH
492001
India |
| Phone |
9827276620 |
| Fax |
|
| Email |
prati_jain@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anesthesiology and pain medicine Pt JNM Medical college Raipur Chhattisgarh, 492001, India |
|
|
Primary Sponsor
|
| Name |
Department of Anesthesiology and pain medicine Pt JNM Medical college Raipur |
| Address |
In front of central jail moudhapara Raipur C.G. pincode:492001 INDIA |
| 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 |
| Dr Rajendra jhariya |
Dr. Bhimrao Ambedkar Memorial hospital Raipur |
Department of anesthesia and pain Medicine and cesarian OT department of Obstetrics and Gynecology Pt JNM medical college Raipur
Raipur
CHHATTISGARH |
7987255640
Rajendra.jhariya1996@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Pt JNM Medical College Raipur (C.G.) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O141||Severe pre-eclampsia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Intravenous lignocaine |
Group B will recive nebulization with 5ml NS, 15 minute before induction + Intravenous Lignocaine 2% 1.5mg/kg, 3minute before induction |
| Comparator Agent |
Lignocaine Nebulization |
Group A will recieve Nebulization with 4% Lignocaine 2 mg/kg, 15 minute before induction + IV NS 3ml, 3 minute before induction |
| Intervention |
Nebulized and intravenous lignocaine (anaesthetic drug) |
Intravenous Cannula inserted as per standard protocol |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Parturients with severe preeclampsia (Systolic blood pressure more than 160 mmhg or diastolic blood pressure more than 110 mmhg at two occasions at least 4 hour apart, new onset headache or visual disturbance, platelet less than1 lakh, epigastric pain) undergoing Lower Segment cesarian section
2. Mallampatti grading I and II |
|
| ExclusionCriteria |
| Details |
1. More than one attempt of intubation
2. Time taken for intubation more than 40 seconds
3. Any cardiac diseases, uncontrolled diabetes mellitus
4. Creatinine more than 2mg/dl, elevated liver enzyme |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Difference in Systolic blood pressure
2.Difference in Diastolic blood pressure
3.Difference in mean arterial pressure
4.Difference in heart rate |
Baseline (Before nebulization) T0
Before iv injection (T1)
Before induction (T2)
After induction & before laryngoscopy (T3)
After laryngoscopy & before intubation(T4)
After intubation (T5)
1MIN (T6)
1 MIN 30 SEC (T7)
2MIN (T8)
2 MIN 30 SEC (T9)
3 MIN (T10)
3MIN 30 SEC (T11)
4MIN (T12)
4MIN 30 SEC (T13)
5MIN |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Incidence and grade of coughing during extubation
2.Incidence and grade of hoarseness
3.Incidence and grade of post operative sorethroat
4.Neonatal outcome (APGAR score) |
Grade of cough at from the end of surgery to 5 minute after extubation
Hoarseness at 1 & 2 hour after PACU admission
Post operative sore throat at 1 & 2 hour after PACU admission
APGAR score at 1 & 5 minute after baby delivered
|
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
18/07/2025 |
| 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="1"
Months="0"
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
|
This is randomized double blind study comparing efficacy of nebulized versus intravenous lignocaine for attenuation of pressor response during laryngoscopy and intubation on patients with severe preeclampsia undergoing LSCS under general anaesthesia. Patients will be enrolled with sample size of 80 (40 in each group) after clinical evaluation and informed consent. Participants will be randomly divided into two groups by computer-generated numbers to receive either nebulized lignocaine or intravenous lignocaine as premedication. Standard monitoring and anaesthesia protocols will be followed, including induction under general anaesthesia and maintenance with isoflurane, nitrous oxide, and oxygen. As primary outcome vitals will be monitored during the preoperative period, before induction, after laryngoscopy and intubation, and every 30 seconds until 5 minutes and secondary outcome will be Neonatal Apgar scores recorded at 1 and 5 minutes after the baby is delivered Cough score using a 4-point scale, hoarseness of voice and sore throat at 1 and 2 hours postoperatively using standardized grading systems, and patients will be observed in the PACU for 24 hours |