| CTRI Number |
CTRI/2024/03/064761 [Registered on: 26/03/2024] Trial Registered Prospectively |
| Last Modified On: |
22/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to compare cisatracurium and atracurium during general anesthesia. |
|
Scientific Title of Study
|
A comparative study of onset, duration and intubating conditions of cisatracurium and atracurium during 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 |
Josiah Peter Andrews |
| Designation |
PG Resident - Department of Anesthesia |
| Affiliation |
Pacific Medical College and Hospital |
| Address |
Pacific Medical College and Hospital,
Department of Anesthesia,
Bhillon Ka Bedla,
Udaipur,
Rajasthan
Udaipur
RAJASTHAN
313001
India |
| Phone |
6238427729 |
| Fax |
|
| Email |
josiahpa@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sameer Goyal |
| Designation |
Professor - Department of Anesthesia |
| Affiliation |
Pacific Medical College and Hospital |
| Address |
Pacific Medical College and Hospital,
Department of Anesthesia,
Bhillon Ka Bedla,
Udaipur,
Rajasthan
Udaipur
RAJASTHAN
313001
India |
| Phone |
8890802830 |
| Fax |
|
| Email |
sameergoy@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Josiah Peter Andrews |
| Designation |
PG Resident - Department of Anesthesia |
| Affiliation |
Pacific Medical College and Hospital |
| Address |
Pacific Medical College and Hospital,
Department of Anesthesia,
Bhillon Ka Bedla,
Udaipur,
Rajasthan
Udaipur
RAJASTHAN
313001
India |
| Phone |
6238427729 |
| Fax |
|
| Email |
josiahpa@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Pacific Medical College And Hospital, Udaipur |
|
|
Primary Sponsor
|
| Name |
Pacific Medical College and Hospital |
| Address |
Pacific Medical College and Hospital, Bhillon Ka Bedla,
Udaipur - 313001
Rajasthan
|
| Type of Sponsor |
Private 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 Sameer Goyal |
Pacific Medical College and Hospital, Udaipur |
Department of Anesthesia
Pacific Medical College and Hospital
Bhillon Ka Bedla
Udaipur - 313001
Rajasthan
Udaipur
RAJASTHAN |
8890802830
sameergoy@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Pacific Medical College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H65-H75||Diseases of middle ear and mastoid, (2) ICD-10 Condition: K315||Obstruction of duodenum, (3) ICD-10 Condition: K800||Calculus of gallbladder with acutecholecystitis, (4) ICD-10 Condition: N200||Calculus of kidney, (5) ICD-10 Condition: N630||Unspecified lump in unspecified breast, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Injection Atracurium |
Injection Atracurium 0.5mg/kg (2xED95) loading dose to first maintenance dose in general anesthesia surgeries. |
| Comparator Agent |
Injection Cisatracurium |
Injection Cisatracurium 0.15mg/kg(3xED95) loading dose to first maintenance dose in general anesthesia surgeries. |
| Comparator Agent |
Injection Cisatracurium |
Injection Cisatracurium 0.1mg/kg (2xED95) loading dose to first maintenance dose in general anesthesia surgeries. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patient willing to give consent.
Age between 18 to 65 years of both sexes
Patients belonging to ASA Grade - I and II
Mallampati Classification – I and II
Elective Surgeries
Weight 50 – 80kg
|
|
| ExclusionCriteria |
| Details |
Patients who have refused consent.
Patients with Neuromuscular disease
Known or anticipated difficult airway
Patient receiving drugs known to interact with neuromuscular blocking agents
Pregnant and lactating women
Patients with cardiovascular, hepatic and renal disorders
Patients with known drug allergy to any of the study drugs
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Through this study we will be able to know whether Cisatracurium or Atracurium is a better non-depolarizing muscle relaxant in regards to onset, duration and intubating conditions during General Anesthesia. |
24 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Same as above |
24 months |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
02/04/2024 |
| 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="2"
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
|
An ideal neuromuscular blocking agent for intubation should have a rapid onset, a brief duration of action, free from hemodynamic changes, devoid of residual paralysis and provide excellent intubating conditions like fully relaxed jaw, widely open vocal cord and absence of intubation-response.
Through this study we will be able to know whether Cisatracurium or Atracurium is a better non- depolarizing muscle relaxant in regards to onset, duration and intubating conditions during general anesthesia.
|