| CTRI Number |
CTRI/2022/10/046472 [Registered on: 13/10/2022] Trial Registered Prospectively |
| Last Modified On: |
13/10/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of characteristics of Cisatracurium drug with different doses in elderly patients undergoing general anaesthesia. |
|
Scientific Title of Study
|
Comparison of neuromuscular blocking characteristics of Cisatracurium with and without its priming dose in elderly patients undergoing general anaesthesia. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Manish Kumar |
| Designation |
Post graduation resident doctor |
| Affiliation |
ABVIMS and Dr. RML Hospital |
| Address |
Department of anaesthesiology, ABVIMS and Dr. RML Hospital, Baba Kharak Singh Marg, New Delhi 110001
Central
DELHI
110001
India |
| Phone |
9910383656 |
| Fax |
|
| Email |
postmkumar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vijay Kumar Nagpal |
| Designation |
Professor |
| Affiliation |
ABVIMS and Dr. RML Hospital |
| Address |
Department of anaesthesiology, ABVIMS and Dr. RML Hospital, Baba Kharak Singh Marg, New Delhi 110001
Central
DELHI
110001
India |
| Phone |
9968304240 |
| Fax |
|
| Email |
nagpalvijaykumar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vijay Kumar Nagpal |
| Designation |
Professor |
| Affiliation |
ABVIMS and Dr. RML Hospital |
| Address |
Department of anaesthesiology, ABVIMS and Dr. RML Hospital, Baba Kharak Singh Marg, New Delhi 110001
Central
DELHI
110001
India |
| Phone |
9968304240 |
| Fax |
|
| Email |
nagpalvijaykumar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of anaesthesiology, ABVIMS and Dr. RML Hospital, Baba kharak Singh marg, New Delhi 110001 |
|
|
Primary Sponsor
|
| Name |
Department of anaesthesiology |
| Address |
ABVIMS and Dr. RMLHospital, Baba kharak Singh marg, New Delhi 110001 |
| 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 |
| Vijay Kumar Nagpal |
Dr. RML Hospital |
Department of anaesthesiology, 3rd floor, PGIMER building, ABVIMS and Dr. RML Hospital
Central
DELHI |
9968304240
nagpalvijaykumar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The institutional ethics committee, ABVIMS and Dr RML Hospital, New Delhi |
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 |
Control group |
This group will receive Normal Saline 5 ml, after 2 to 3 minutes full intubating dose of Cisatracurium at 0.15 mg/kg will be given. |
| Intervention |
Study group |
This group will receive priming dose of injection cisatracurium IV (0.015 mg/kg) & will dilute it with Normal Saline to make 5 ml, after 2 to 3 minutes remaining intubating dose of 0.135mg/kg will be given to patients. |
|
|
Inclusion Criteria
|
| Age From |
65.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
BMI 18-30, ASA grade 1&2, Modified Mallampati grade 1&2. |
|
| ExclusionCriteria |
| Details |
Patients with anticipated difficult airway, uncontrolled DM, uncontrolled hypertension, untreated CAD, post CVA, extremes of weight, uncontrolled asthma, neuromuscular disorders, history of atopy, active copd, patients on antibiotics, known history of allergy to Cisatracurium. |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Time to onset of neuromuscular block. |
Time at which TOF count is 2/4 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Time to complete block. |
Time at which TOF count is 4/4 |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
25/10/2022 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
AIM To compare neuromuscular blocking characteristics of cisatracurium with and without its priming dose in elderly patients undergoing General Anaesthesia.
PRIMARY OBJECTIVE :- To compare the effect on time of onset of action of cisatracurium given with and without its priming dose in elderly patients undergoing General Anaesthesia.
SECONDARY OBJECTIVES :- 1.) To compare the effect on the time to complete block of cisatracurium given with and without its priming dose in elderly patients undergoing General Anaesthesia. 2.) To compare hemodynamic parameters and side effect profile in patients of two groups.
METHOD OF RANDOMIZATION 60 ASA grade I and II patients will be divided into two groups 1 and 2 by using computer generated random number table. GROUP 1 (n= 30) : Patients will receive Priming Dose of Inj. Cisatracurium at dose of 0.015 mg/kg. GROUP 2 (n=30) : Patients will receive Normal Saline 5 ml.
METHOD OF PREPARING PRIMING DOSE :- Group 1 (n=30) will receive priming dose of injection cisatracurium IV (dose as per weight) & will dilute it with Normal Saline to make 5 ml. Group 2 (n=30) will receive Normal Saline 5 ml.
METHOD OF GIVING GENERAL ANESTHESIA A preanesthetic evaluation will be done for all the cases. Written and Informed Consent will be taken. All patients will be kept fasting for 8 hours night before surgery. In OT , multipara monitors will be attached to record ECG, Non-invasive blood pressure (NIBP), SpO2 , End-tidal Carbon dioxide (Et CO2) and temperature. Baseline parameters will be recorded for all patients. IV access will be established. Neuromuscular monitoring apparatus will be attached to the patient. NMT apparatus will be set to TOF with supramaximal stimulus at 0.05 Hz and frequency at 20 seconds. Patient will be pre-oxygenated with 100% O2 for 3 minutes using appropriate size face mask. Patients will receive Inj. Midazolam 0.03 mg/ kg IV, Inj. Fentanyl 2 mcg /kg IV Priming dose will be given in group 1 as 0.015 mg/kg in Normal Saline to make 5 ml solution and 5 ml Normal Saline only will be given in group 2. We will wait for 3 minutes after giving priming dose and before starting induction of anaesthesia.
METHOD OF ONSET OF ACTION : Time of onset will be noted when TOF count is 2/4
METHOD OF KNOWING COMPLETE BLOCK : Time to complete block will be noted when TOF count is 0/4
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