| CTRI Number |
CTRI/2018/04/013537 [Registered on: 27/04/2018] Trial Registered Prospectively |
| Last Modified On: |
24/01/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Comparative study |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Blood pressure changes with different equipment used for anaesthesia |
|
Scientific Title of Study
|
To compare haemodynamic changes during MacIntosh, McCoy and video laryngoscopy |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Joginder Pal |
| Designation |
Professor |
| Affiliation |
Govt Medical College Amritsar |
| Address |
Department of Anaesthesia
Govt Medical College, Amritsar
Amritsar
PUNJAB
143001
India |
| Phone |
9501025275 |
| Fax |
|
| Email |
drjpattri@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ruchinder Kaur |
| Designation |
Junior Resident |
| Affiliation |
Govt Medical College Amritsar |
| Address |
Department of Anaesthesia
Govt Medical College, Amritsar
Amritsar
PUNJAB
143001
India |
| Phone |
|
| Fax |
|
| Email |
ruchinderrandhawa@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ruchinder Kaur |
| Designation |
Junior Resident |
| Affiliation |
Govt Medical College Amritsar |
| Address |
Department of Anaesthesia
Govt Medical College, Amritsar
Amritsar
PUNJAB
143001
India |
| Phone |
|
| Fax |
|
| Email |
ruchinderrandhawa@gmail.com |
|
|
Source of Monetary or Material Support
|
| Guru Nanak Dev Hospital Amritsar |
|
|
Primary Sponsor
|
| Name |
Govt Medical College Amritsar |
| Address |
Deptt of Anaesthesia
GMC Amritsar |
| 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 Joginder Pal |
Guru Nanak Dev Hospital Amritsar |
Department of Anaesthesia and ICU, Guru Nanak Dev Hospital, Majitha road
Amritsar
PUNJAB |
9501025275
drjpattri@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
ASA Grade I and II, (1) ICD-10 Condition: K801||Calculus of gallbladder with othercholecystitis, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. ASA grade I and II patients.
2. Patients between 15-65 yrs of age.
3. Mallampati grade I and II patients.
|
|
| ExclusionCriteria |
| Details |
1. Patients with hepatic dysfunction, renal dysfunction and severe cardiac dysfunction (ef<55 %)
2. Patients with difficult airway (Mallampati grade III and IV)
3. Morbidly obese patients.
4. Patients with neurological disease and severe respiratory disease
5. ASA grade 3 and 4 patients
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the pressor responses during laryngoscopy with macintosh vs McCoy vs video laryngoscope. Pressor responses will be including :-
1. Systolic blood pressure
2. Diastolic blood pressure
3. Mean arterial blood pressure
4. Heart rate
5. Electrocardiographic changes
|
10 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Any complications arising from above procedure.
2. Any sore throat incidences post extubation.
|
24 hours |
|
|
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 1 |
|
Date of First Enrollment (India)
|
30/04/2018 |
| 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="1"
Days="1" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Other (Terminated) |
|
Publication Details
|
Non yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Hemodynamic changes
that occur during laryngoscopy and intubation can significantly increase the
risk of ischemia in cardiac and cerebrovascular patients. Our basic goal will
be directed towards attenuation of these stress responses in ASA grade I and II
patients. We will divide our patients into three groups A,B and C comprising of
30 patients each. Group A will be intubated with conventional Macintosh
laryngoscope, Group B will be intubated with McCoy laryngoscope and Group C
will be intubated with Video laryngoscope. All these groups will receive same
pre-medication and inducing drugs. In the end of the study, hemodynamic changes
to different kinds of laryngoscopies will be observed, compared and analysed. Hemodynamic
parameters will comprise of heart rate, systolic blood pressure, diastolic
blood pressure, mean arterial blood pressure and electrocardiographic changes. These
Hemodynamic parameters will be recorded in patients undergoing intubation
during general anaesthesia in elective open cholecystectomy surgeries. |