| CTRI Number |
CTRI/2023/08/056012 [Registered on: 02/08/2023] Trial Registered Prospectively |
| Last Modified On: |
31/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A comparitive study between two muscle relaxants. |
|
Scientific Title of Study
|
Comparison of Cisatracurium with Atracurium with regard to intubating conditions and haemodynamic parameters during laryngoscopy in patients undergoing surgical procedures under general anaesthesia in a Tertiary Care Hospital in Sikkim. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Thumu Jaisheel Gabriel Joseph |
| Designation |
Post Graduate Trainee |
| Affiliation |
Central Referral Hospital |
| Address |
Room No 1, PG Room, Dept of Anaesthesiology and Critical Care, Main OT complex, Level 6, Central Referral Hospital, Sikkim Manipal Institute of Medical Sciences, 5th Mile, Tadong, Gangtok, Sikkim
East
SIKKIM
737102
India |
| Phone |
8116212923 |
| Fax |
|
| Email |
jaisheel1996@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Meyong Pincho Bhutia |
| Designation |
Professor |
| Affiliation |
Sikkim Manipal Institute of Medical Sciences |
| Address |
Consultants Room, Dept of Anaesthesiology and Critical Care, Main OT complex, Level 6, Central Referral Hospital, Sikkim Manipal Institute of Medical Sciences, 5th Mile, Tadong, Gangtok, Sikkim
East
SIKKIM
737102
India |
| Phone |
8617064429 |
| Fax |
|
| Email |
meyongbhutia@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Meyong Pincho Bhutia |
| Designation |
Professor |
| Affiliation |
Sikkim Manipal Institute of Medical Sciences |
| Address |
Consultants Room, Dept of Anaesthesiology and Critical Care, Main OT complex, Level 6, Central Referral Hospital, Sikkim Manipal Institute of Medical Sciences, 5th Mile, Tadong, Gangtok, Sikkim
East
SIKKIM
737102
India |
| Phone |
8617064429 |
| Fax |
|
| Email |
meyongbhutia@gmail.com |
|
|
Source of Monetary or Material Support
|
| Level 6, Main OT Complex, Central Referral Hospital, Sikkim Manipal Institute of Medical Sciences, 5th Mile, Tadong, Gangtok ,Sikkim 737102 |
|
|
Primary Sponsor
|
| Name |
Dr Thumu Jaisheel Gabriel Joseph |
| Address |
Room 507, PG Hostel, Sikkim Manipal Institute of Medical Sciences, 5th Mile, Tadong, Gangtok, Sikkim 737102 |
| Type of Sponsor |
Other [Principal Investigator] |
|
|
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 Thumu Jaisheel Gabriel Joseph |
Central Referral Hospital, Sikkim Manipal Institute of Medical Sciences |
Room No 1, PG Room, Dept of Anaesthesiology and Critical Care, Main OT complex, Level 6, Central Referral Hospital, Sikkim Manipal Institute of Medical Sciences, 5th Mile, Tadong, Gangtok, Sikkim
East
SIKKIM |
8116212923
jaisheel1996@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMIMS Institution Ethics Committee |
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 |
Atracurium |
A comparison of already used Atracurium with a newer muscle relaxant Cisatracurium in regards to heamodynamic parameters and intubating conditions. |
| Intervention |
Cisatracurium |
A comparison of Cisatracurium a newer muscle relaxant with Atracurium with regards to heamodynamic parameters and intubating conditions. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. American society of Anaesthesiology score [ASA]
I and 2
2. Both Males and Females
3. Age between 18 years and 60 years
4. Patients requiring endotracheal intubation
undergoing General anaesthesia
5. Patients undergoing only Elective Procedures |
|
| ExclusionCriteria |
| Details |
1. Any systemic co-morbidity including uncontrolled hypertension and diabetes, Heart block, renal impairment (serum creatinine greater than 2mg/dl, hepatic impairment (trans-aminases greater than double the normal values), psychiatric disorders like Schizophrenia and Mania
2. Patient not giving consent
3. ASA Grade 3 and Grade 4 patients
4. Patients with history of Bronchial Asthma
5. Patient on any addictive drug or allergic to any drugs used in the trial
6. Pregnant patient and lactating mothers
7. Anticipated Difficult Airway (Mallampati Class III and IV, thyromental height < 6 cm, inter-incisor distance <3cm and cervical instability.) |
|
|
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 |
1. To compare the effect of Muscle Relaxation between Atracurium & Cis Atracurium by comparing the ease of intubation
2. To compare the change in haemodynamic parameters while using either Atracurium or Cis Atracurium |
10 minutes after induction |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To compare the Time interval for first maintenance dose between Atracurium & Cis atracurium
2. To compare cost effectiveness between Atracurium & Cis atracurium |
At baseline |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
08/08/2023 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study aims at the comparison of two routinely used muscle relaxants which are Cisatracurium and Atracurium in regards to Haemodynamic conditions using ASA approved cardiac monitors, intubating conditions using stardardized gradings and compiling these results to conclude the better among the two drugs involved |