| CTRI Number |
CTRI/2019/05/019453 [Registered on: 30/05/2019] Trial Registered Prospectively |
| Last Modified On: |
29/05/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparision of effect of cisatracurium and vecuronium (both muscle relaxant) in a patient undergoing laproscopic appendicectomy |
|
Scientific Title of Study
|
Evaluation of haemodynamic and pharmacodynamic effects of cisatracurium and vecuronium in participants undergoing laproscopic appendicectomy:A prospective randomized parallel group double blind clinical trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nimisha Tank |
| Designation |
Juniour Resident |
| Affiliation |
Government medical college bhavnagar |
| Address |
Department of Anaesthesiology,
Sir T Hospital
Bhavanagar
Government medical college
Bhavnagar
Bhavnagar
GUJARAT
364001
India |
| Phone |
9913490328 |
| Fax |
|
| Email |
nimishatank689@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shilpa Doshi |
| Designation |
Associate Professor |
| Affiliation |
Government medical college Bhavnagar |
| Address |
Department of Anaesthesiology
Bhavanagar
Government medical college
Bhavnagar
Bhavnagar
GUJARAT
364001
India |
| Phone |
9428810763 |
| Fax |
|
| Email |
drshilpadoshi@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nimisha Tank |
| Designation |
Juniour Resident |
| Affiliation |
Government medical college Bhavnagar |
| Address |
Department of Anaesthesiology
Bhavanagar
Government medical college
Bhavnagar
Bhavnagar
GUJARAT
364001
India |
| Phone |
9913490328 |
| Fax |
|
| Email |
nimishatank689@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dhanvantari Granthalaya electronic data base Government medical college
Near jail road Bhavanagar |
|
|
Primary Sponsor
|
| Name |
Government medical college Bhavnagar |
| Address |
Sir T hospital Government medical college Bhavnagar 364001 Gujarat |
| 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 Nimisha Tank |
Sir T hospital |
Department of surgery
second floor, Sir T hospital
Bhavanagar
Bhavnagar
GUJARAT |
9913490328
nimishatank689@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional review board, GMC, Bhavanagar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K353||Acute appendicitis with localizedperitonitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Injection Cisatrcurium |
Cisatracurium is also non depolarizing muscle relexant with more potency and slower onset of action with 30 to 60 minute of duration of action.
it releases very less amount of histamine so more cardiostable agent.
it is eliminated by hoffmann elimination so used in both renal or hepatic failure.
Loading dose-0.15 mg/kg
Maintenance dose-0.03 mg/kg |
| Comparator Agent |
Injection Vecuronium |
Vecuronium is a non depolarizing muscle relaxant with intermediate duration of action, and most popular agent used.
it is eliminated by both hepatic and renal route so effects are prolonged in both hepatic or renal failure.
Loading dose-0.10 mg/kg
Maintenance dose-0.02 mg/kg |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1)Informed written consent
2)18 to 50 years of age
3)Patient is of either gender
4)ASA physical status I and II
5)Undergoing elective laproscopic appendicectomy
6)Requiring endotracheal intubation |
|
| ExclusionCriteria |
| Details |
1)Refusing to give consent
2)Anticipated difficult airway
3)Pre existing liver or renal failure
4)Therapy with drug known to interfere with neuromuscular transmission
5)Antenatal and lactating females
6)Prolonged preoperative bed rest
7)Patient having neuromuscular disorders
8)ASA physical status III and IV |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
1)Time of onset of action
2)Intubation time
3)Time interval between loading and first maintenance dose
4)Time interval between maintenance doses
5)Extubation time
6)Total number of doses required
|
1)Noted when TOF count is reduced to 3 on PNS afer giving loading dose
2)Noted when no response to TOF on PNS after giving loading dose
3)Noted when TOF count is more than 2 on PNS after giving loading dose
4)Noted when TOF count is more than 2 on PNS after giving top up dose of drug
5)Noted from end of the operation to extubation and TOF count is 4 on PNS
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Haemodynamic effects( pulse, non invasive blood pressure monitoring) |
Baseline
5 min. after inj. fentanyl
After intubation
At 10 min. ,20 min.,30 min.,60 min.,90 min. ,120 min.,
At the end of operation
At extubation
2 min. after extubation |
|
|
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)
|
03/06/2019 |
| 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="1"
Months="6"
Days="15" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Neuromuscular blocking agents (NBM’S) both depolarizing and non depolarizing are routinely used to facilitate tracheal intubation during induction of anaesthesia and to maintain satisfactory muscle relaxation during surgery. Atracurium, a non depolarizing muscle relexant with an intermediate duration of action is independent of hepatic and renal functions to terminate its action and had minimal side effects but it also shows weak histamine releasing properties which contribute to many of its cardiovascular side effects. Thus newer agent cis-atracurium has no histamine releasing properties, greater haemodynemic stability, hoffmann degradation so elimination of drug is independent of hepatic and renal failure. |