| CTRI Number |
CTRI/2025/07/091623 [Registered on: 24/07/2025] Trial Registered Prospectively |
| Last Modified On: |
23/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A comparison of 2 medicine for assessing quality of intubation (insertion of breathing tube in windpipe) |
|
Scientific Title of Study
|
Randomized prospective study to compare intubating conditions with cis-atracurium or atracurium under sevoflurane induction using train of four neuromuscular monitoring in adult patients undergoing elective surgery. |
| 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 Prateek Rastogi |
| Designation |
Junior Resident |
| Affiliation |
Lala Lajpat Rai Memorial Medical College Meerut |
| Address |
Department of Anaesthesia, Lala Lajpat Rai Memorial Medical College, Meerut, Uttar Pradesh India 250004
Meerut
UTTAR PRADESH
250004
India |
| Phone |
9650279444 |
| Fax |
|
| Email |
prateek1804@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vipin Kumar Dhama |
| Designation |
Professor |
| Affiliation |
Lala Lajpat Rai Memorial Medical College Meerut |
| Address |
Department of Anaesthesia, Lala Lajpat Rai Memorial Medical College, Meerut, Uttar Pradesh India 250004
Meerut
UTTAR PRADESH
250004
India |
| Phone |
9760014177 |
| Fax |
|
| Email |
drvipindhama@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prateek Rastogi |
| Designation |
Junior Resident |
| Affiliation |
Lala Lajpat Rai Memorial Medical College Meerut |
| Address |
Department of Anaesthesia, Lala Lajpat Rai Memorial Medical College, Meerut, Uttar Pradesh India 250004
Meerut
UTTAR PRADESH
250004
India |
| Phone |
9650279444 |
| Fax |
|
| Email |
prateek1804@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia, LLRM medical college Meerut 250004 |
|
|
Primary Sponsor
|
| Name |
LLRM medical college Meerut |
| Address |
Department of Anaesthesia, LLRM medical college, Meerut, Uttar
Pradesh 250004 |
| 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 Prateek Rastogi |
LLRM medical college Meerut |
Department of Anaesthesia
Meerut
UTTAR PRADESH |
9650279444
prateek1804@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee |
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. atracurium |
Loading dose of atracurium 0.5mg/kg under sevoflurane maintainence dose of 0.2mg/kg given to patients. |
| Comparator Agent |
Inj. cis-atracurium |
Loading dose of cis-atracurium 0.15mg/kg under sevoflurane maintainence dose of 0.03mg/kg given to patients. |
| Intervention |
To evaluate intubating conditions using train of four neuromuscular monitoring |
TOF Monitoring will be done every 30 seconds during sevoflurane and after giving loading dose of nondepolarizing neuromuscular blocking agents, every 30seconds till 4min ,followed by every 5min till 30minutes in all the participants of the study. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA GRADE 1 & 2 PATIENTS UNDERGOING ELECTIVE SURGERY WITH INFROMED CONSENT. |
|
| ExclusionCriteria |
| Details |
PATIENTS UNDER FOLLOWING CONDITIONS:-
1.PATIENTS REFUSAL
2.PREGNANCY
3.COAGULOPATHY
4.ANTICIPATED DIFFICULT AIRWAY
5.ANY SEVERE SYSTEMIC DISEASE |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate and compare the intubating conditions and quality of neuromuscular blockade using train of four. |
Intubating conditions and neuromuscular blockade will be assessed intaoperatively at baseline. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare systemic effect of cis-atracurium and atracurium on hemodynamic parameters (viz. heart rate, systolic and diastolic blood pressure, oxygen saturation) |
hemodynamic parameters (heart rate; blood pressure, SPO2) will also be noted every 1min till 10minutes and every 2 min. till next 20 minutes to look for the effect of drugs on heart rate, blood pressure |
|
|
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
15/08/2025 |
| 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 Yet Recruiting |
| 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 study is randomized prospective study to compare intubating conditions with cis-atracurium or atracurium under sevoflurane induction using train of four neuromuscular monitoring in adult patients undergoing elective surgery.
Also in this study , systemic effects of cis-atracurium and atracurium on hemodynamic parameters (viz .heart rate, systolic and diastolic blood pressure, oxygen saturation) are compared. |