| CTRI Number |
CTRI/2021/08/035869 [Registered on: 24/08/2021] Trial Registered Prospectively |
| Last Modified On: |
17/08/2021 |
| 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 study to compare the conditions for intubation of two drugs used as muscle relaxants namely Cisatracurium and Rocuronium. |
|
Scientific Title of Study
|
A Randomised Double-blind Study to Compare the Intubating Conditions of Cisatracurium and Rocuronium for Intubation |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anjali Anna Thomas |
| Designation |
Post graduate resident |
| Affiliation |
Malankara Orthodox Syrian Church Medical College and Hospital |
| Address |
Department of Anesthesiology and Critical Care,
Malankara Orthodox Syrian Church Medical College and Hospital,
Kolenchery
Ernakulam district
Kerala
Kadavil Athanni, Puthencavu P.O,
Chengannur
Alappuzha district
Kerala
Pin code 689123
Alappuzha
KERALA
682311
India |
| Phone |
9567715967 |
| Fax |
|
| Email |
anjaliannathomas@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrRakhee S |
| Designation |
Professor |
| Affiliation |
Malankara Orthodox Syrian Church Medical College and Hospital |
| Address |
Department of Anesthesiology and Critical Care,
Malankara Orthodox Syrian Church Medical College and Hospital,
Kolenchery
Ernakulam district
Kerala
Ernakulam
KERALA
682311
India |
| Phone |
9495567033 |
| Fax |
|
| Email |
rakheeksd79@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Anjali Anna Thomas |
| Designation |
Post graduate resident |
| Affiliation |
Malankara Orthodox Syrian Church Medical College and Hospital |
| Address |
Department of Anesthesiology and Critical Care,
Malankara Orthodox Syrian Church Medical College and Hospital,
Kolenchery
Ernakulam district
Kerala
Kadavil Athanni, Puthencavu P.O,
Chengannur
Alappuzha district
Kerala
Pin code 689123
KERALA
682311
India |
| Phone |
9567715967 |
| Fax |
|
| Email |
anjaliannathomas@gmail.com |
|
|
Source of Monetary or Material Support
|
| Malankara Orthodox Syrian Church Medical College and Hospital |
|
|
Primary Sponsor
|
| Name |
Malankara Orthodox Syrian Church Medical College |
| Address |
Kolenchery, Ernakulam district
Pin code 682311 |
| 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 |
| Anjali Anna Thomas |
Malankara Orthodox Syrian Church Medical College and Hospital |
Department of Anaesthesia and Critical Care/Room number 409
Ernakulam
KERALA |
9567715967
anjaliannathomas@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ECR/728/Inst/KI/2015/RR-18 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
With the exception of anticipated difficult intubation as seen in MP III or IV, chronic alcoholics, patients with diseases affecting neuromuscular transmission |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Cistracurium |
Cistracurium is a non depolarizing muscle relaxant that is used to achieve muscle relaxation for endotracheal intubation and surgical procedures. In this study, we would like to find out if Cistracurium at a dosage of 0.3mg/kg could provide a early onset of action so that it could be used in patients with renal failure where Succinyl choline and Rocuronium are contraindicated. |
| Comparator Agent |
Rocuronium |
Rocuronium is a non depolarizing muscle relaxant that can be used in Rapid sequence induction at a dose of 0.9mg/Kg when Succinyl choline is contraindicated (due to its rapid onset of action). In this study, Rocuronium will be used in the dose of 0.9mg/kg |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
All patients undergoing surgeries requiring general anesthesia (procedures requiring general anesthesia for one hour or more).
ASA Status of I and II.
BMI between 20 - 30 kg/m2. |
|
| ExclusionCriteria |
| Details |
Patients with anticipated difficult intubation.
Chronic alcoholics.
Patients with diseases affecting neuromuscular transmission.
Patients on medications known to interfere with neuromuscular blockers. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Onset time and intubating conditions of Cisatracurium and Rocuronium based on TOF stimuli and Copper Grading system respectively |
Assessed at 30 seconds interval |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Hemodynamic parameters between the two drugs are compared.
Duration of action of the two drugs in the given doses are compared. |
Baseline values of hemodynamic parameters noted, followed by at one minute interval before intubation and at every five minute interval after intubation up to 30 minutes. |
|
|
Target Sample Size
|
Total Sample Size="216"
Sample Size from India="216"
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)
|
31/08/2021 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Neuromuscular blockers are commonly used in general anaesthesia for endotracheal intubation and for providing muscle relaxation intraoperatively. An ideal neuromuscular blocking agent needs to take the shortest time to provide muscle relaxation for laryngoscopy and endotracheal intubation and furnish the best intubating conditions. Such drugs are especially useful in rapid sequence intubation in emergencies in the presence of a full stomach or conditions with an increased risk of aspiration. Rocuronium bromide is an aminosteroid non-depolarizing neuromuscular blocker. It has become one of the most popular non-depolarizing neuromuscular blockers in clinical anesthesia due to its rapid onset of action. It becomes handy for rapid sequence intubation where succinylcholine is contraindicated. But it has the disadvantage that it accumulates in renal failure. Cisatracurium is a stereoisomer of a nondepolarizing neuromuscular blocker Atracurium and has an intermediate duration of action. Cisatracurium undergoes Hoffmann degradation and produces the metabolite Laudanosine. This study is planned to find out if Cisatracurium can be used as an alternative to Rocuronium for rapid sequence intubation by comparing the onset time of the drugs in the given doses, intubating conditions, the duration of action of the drugs in the given doses, and hemodynamic parameters.
STUDY HYPOTHESIS : There is no significant difference in the onset time and intubating conditions between Cisatracurium and Rocuronium for intubation. There is no difference in the duration of action of Cisatracurium and Rocuronium in the dose used. There is no significant difference in the hemodynamic parameters between Cisatracurium and Rocuronium. |