| CTRI Number |
CTRI/2019/08/020647 [Registered on: 09/08/2019] Trial Registered Prospectively |
| Last Modified On: |
08/08/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Clinical trial to study the effect of two different muscle relaxant named Cis-Atracurium vs Rocuronium during General Anaesthesia for Laparoscopic Gall Bladder Suregry |
|
Scientific Title of Study
|
Cis-atracurium in different doses vs Rocuronium in Laparoscopic Cholecystectomy Surgery under General Anaesthesia: Prospective, Comparative, Randomised Controlled study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Samir Basak |
| Designation |
Divisional Medical Officer ( Anaesthesia) |
| Affiliation |
Central Hospital ,South Eastern Railway |
| Address |
Operation Theatre Complex,2nd Floor, Central Hospital,South Eastern Railway
11 Garden Reach Road
Kolkata
WEST BENGAL
700043
India |
| Phone |
9143067142 |
| Fax |
03324391330 |
| Email |
drsamirbasak@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Samir Basak |
| Designation |
Divisional Medical Officer ( Anaesthesia) |
| Affiliation |
Central Hospital ,South Eastern Railway |
| Address |
OT complex, 2nd Floor,Central Hospital,South Eastern Railway
11 Garden Reach Road
Kolkata
WEST BENGAL
700043
India |
| Phone |
9143067142 |
| Fax |
03324391330 |
| Email |
drsamirbasak@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Samir Basak |
| Designation |
Divisional Medical Officer ( Anaesthesia) |
| Affiliation |
Central Hospital ,South Eastern Railway |
| Address |
OT Complex,2nd Floor,Central Hospital,South Eastern Railway
11 Garden Reach Road
Kolkata
WEST BENGAL
700043
India |
| Phone |
9143067142 |
| Fax |
03324391330 |
| Email |
drsamirbasak@gmail.com |
|
|
Source of Monetary or Material Support
|
| 1.Central Hospital,South Eastern Railway,11 Garden Reach Road,Kolkata-700043,Phone - 03324503478 |
|
|
Primary Sponsor
|
| Name |
Central Hospital Garden Reach South Eastern Railway |
| Address |
11 Garden Reach Road,South Eastern Railway Head Quarter,Kolkata-700043 |
| Type of Sponsor |
Research institution and hospital |
|
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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 Samir Basak |
Central Hospital Garden Reach |
South Eastern Railway Head Quarter,11 Garden Reach Road,Kolkata--700043
Kolkata
WEST BENGAL |
03324504178
03324391330
drsamirbasak@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHICS COMMITTEE, CENTRAL HOSPITAL, SOUTH EASTERN RAILWAY |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K801||Calculus of gallbladder with othercholecystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Cis-Atracurium |
C1 group received 0.15 mg/kg of cisatracurium (3×ED 95 of cisatracurium) after induction of anaesthesia .The calculated dose of Muscle Relaxant will be injected intravenously over 5 s into a rapid infusion of normal saline by an investigator who is not aware of the study. |
| Comparator Agent |
Cis-Atracurium |
C2 group received 0.20 mg/kg of cisatracurium (4×ED 95 of cisatracurium) after induction of anaesthesia .The calculated dose of Muscle Relaxant will be injected intravenously over 5 s into a rapid infusion of normal saline by an investigator who is not aware of the study. |
| Comparator Agent |
Rocuronium |
R group received 0.90 mg/kg rocuronium (3×ED 95 of rocuronium)after induction of anaesthesia .The calculated dose of Muscle Relaxant will be injected intravenously over 5 s into a rapid infusion of normal saline by an investigator who is not aware of the study. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. American Society of Anaesthesiologist Physical Status(ASA-PS) I & II
2. Age group 18 --- 60 yrs.
3. Laparoscopic Cholecystectomy surgery under general anaesthesia & Endotracheal intubation with minimum one hour surgery duration (1.00 hrs)
|
|
| ExclusionCriteria |
| Details |
a. ASA class III or IV
b. Patients with anticipated difficult intubation (Mallampati score III and more),
c. BMI ≥ 30
d. Patient with diseases affecting neuromuscular transmission (myopathies).
e. Patients with severe Cardiovascular, respiratory , renal diseases
f. Patients on drug & alcohol abuses.
g. Gastroesophageal refiux or hiatus hernia.
h. Patients posted for emergency surgery.
i. H/o allergy to drugs frequently used in anaesthesia
j. Patients receiving medication known to interfere with NMBs (anticonvulsants, amino glycosides or polypeptide antibiotics
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Comparison of two different doses of cis-atracurium i.e. (3×ED 95) 0.15 mg/kg & (4×ED 95) 0.20 mg/kg vs Rocuronium(3×ED 95) 0.90 mg/kg in (Total 3 groups i.e. CIS 1,CIS 2,ROC)
1. To compare Onset time of the Muscle Relaxant among 3 groups.
2. To compare Time to intubation among 3 groups .
3. To compare Intubating condition among 3 groups .
4. To compare Clinical duration of the Intubating 1st dose or DUR 25 among 3 groups.
|
August 2019 to February 2020 i.e. 6 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Haemodynamic changes ( Mean Arterial Pressure, Heart Rate) among the three groups.
2. Any Adverse reaction to drugs (itching, pruritus, anaphylaxis) among the groups .
|
August 2019 to February 2020 i.e. 6 month |
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
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)
|
11/08/2019 |
| 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="0"
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)?
|
|
Brief Summary
|
cis-atracurium is non-depolarising neuromuscular blocking agents with advantages like being metabolised by Hoffmann elimination and as a most potent molecule it produces less laudanosine, dose not release histamine in clinical dose ranges .And it is noticed that even after large doses there is no cardiovascular changes . Inspite of these advantages it is of limited use because of slow onset and unsatisfactory intubating condition compared with equipotent doses of other neuromuscular blocking agents like Rocuronium. But we could not use rocuronium in hepatic and renal compromised patients because it mostly metabolised in liver . In this study we will investigate wheather Cis-atracurium with increasing doses can be near ideal neuromuscular blocking agents in comparison to rocuronium in producing acceptable intubating condition with relatively safe and short duration of muscle paralysis. Assuming p value <0.05 to be significant and considering effect to be two sided, we get Za =1.96; assuming power of the study to be 90% we get Z1- b = 1.28 ; considering an effect size of 95 to be statistically significant we get n =25 in each group. Hence minimum 25 patients will be taken in each group. After obtaining approval fro institutional ethical committe & informed written consent will be taken from 25 patients of each group under going general anaesthesia and endotracheal intubation for Laparoscopic Cholecystectomy surgery .All the patients will be put on IV canula & standard monitors (Skanray) including NIBP,ECG,Pulse Oxymetry . Before induction of anaesthesia TOF Scan NMT Monitor probe will be placed on the thumb & monitor will be swiched on. All the patients will receive premedication inj. Fentanyl 2mcg/kg just before induction of anaesthesia. After preoxygenation with 100% oxygen, patient will be induced with 2mg/kg IV Propofol over 30 sec.After loss of consiousness to facilitate tracheal intubation,neuromuscular blocking agents will be infused either with a single bolus dose of Cisatracurium or Rocuronium . The calculated amount of muscle relaxant will be injected over 5 sec into a rapid infusion of normal saline .Following maximal depression of T1 (onset time) , direct laryngoscopy will be initiated followed by tracheal intubation .The ulner nerve will be stimulated at the wrist with a square wave stimulus set at a current of 50 mA and duration of 0.2 ms each will be delivered in a train-of-four (TOF) sequence,repeated every 12 sec using TOF Scan NMT Monitor. After intubation ,anaesthesia will be maintained by 65% nitrous oxide and 3.0 volume % Desflurane (inspired) . |