CTRI Number |
CTRI/2023/05/052779 [Registered on: 17/05/2023] Trial Registered Prospectively |
Last Modified On: |
16/05/2023 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Medical Device Surgical/Anesthesia |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
Change in blood pressure & pulse rate during endotracheal intubation with videolaryngoscopy and conventional laryngoscopy |
Scientific Title of Study
|
Haemodynamic response to laryngoscopy with videolaryngoscopy and conventional direct laryngoscopy in patients requiring endotracheal intubation for general anaesthesia:A randomized comparative study |
Trial Acronym |
NA |
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
DR AKSHATA GAMBHIR CHOUGULE |
Designation |
JUNIOR RESIDENT ANAESTHESIOLOGY |
Affiliation |
Government Medical College and Hospital, Aurangabad. |
Address |
Department of Anaesthesiology
Government Medical College and Hospital Aurangabad
Panchakki road, Aurangabad
Aurangabad MAHARASHTRA 424001 India |
Phone |
9657446916 |
Fax |
-- |
Email |
chougule.akshata.1008@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
DR AKSHATA GAMBHIR CHOUGULE |
Designation |
JUNIOR RESIDENT ANAESTHESIOLOGY |
Affiliation |
Government Medical College and Hospital, Aurangabad. |
Address |
Department of Anaesthesiology
Government Medical College and Hospital Aurangabad
Panchakki road, Aurangabad
Aurangabad MAHARASHTRA 424001 India |
Phone |
9657446916 |
Fax |
-- |
Email |
chougule.akshata.1008@gmail.com |
|
Details of Contact Person Public Query
|
Name |
DR AKSHATA GAMBHIR CHOUGULE |
Designation |
JUNIOR RESIDENT ANAESTHESIOLOGY |
Affiliation |
Government Medical College and Hospital, Aurangabad. |
Address |
Department of Anaesthesiology
Government Medical College and Hospital Aurangabad
Panchakki road, Aurangabad
Aurangabad MAHARASHTRA 424001 India |
Phone |
9657446916 |
Fax |
-- |
Email |
chougule.akshata.1008@gmail.com |
|
Source of Monetary or Material Support
|
Institutional Support-Dean Govt. Medical College, Aurangabad |
|
Primary Sponsor
|
Name |
The Dean GMCHA |
Address |
Government Medical College and Hospital, Aurangabad.
|
Type of Sponsor |
Government medical college |
|
Details of Secondary Sponsor
|
Name |
Address |
Dr G V Tadwalker |
Professor & Head, Dept. of Anaesthesiology, Government Medical College and Hospital, Aurangabad.
|
|
Countries of Recruitment
|
India |
Sites of Study
|
No of Sites = 1 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
Dr Joshi S A |
Government Medical College and Hospital, Aurangabad. |
Operation Theatre 1, 3, 4
Dept. of Anaesthesiology
Government Medical College and Hospital, Aurangabd-INDIA
Aurangabad MAHARASHTRA |
9422777903 -- khadkesuchita@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
INSTITUTIONAL ETHICS COMMITTEE GOVT. MEDICAL COLLEGE AURANGABAD |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: K37||Unspecified appendicitis, (3) ICD-10 Condition: K689||Other disorders of retroperitoneum, (4) ICD-10 Condition: K808||Other cholelithiasis, (5) ICD-10 Condition: N200||Calculus of kidney, (6) ICD-10 Condition: N630||Unspecified lump in unspecified breast, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
Haemodynamic response after endotracheal intubation with conventional Macintosh laryngoscope |
Rise in Heart rate, systolic BP, Diastolic BP, Mean Arterial,Pressure will be measured after endotracheal intubation with conventional Macintosh laryngoscope |
Intervention |
Haemodynamic response to endotracheal intubation with Videolaryngoscope |
Rise in Heart rate, systolic BP, Diastolic BP, Mean Arterial,Pressure will be measured after endotracheal intubation with Videolaryngoscope |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
Patients of both genders posted for surgery under general
anaesthesia, age 18-60 years, BMI<30, ASA Grade I &
II, Mallampatti Grade - I & II
|
|
ExclusionCriteria |
Details |
1 ASA Grade III & IV
2. Mallampatti Grade III & IV
3. Risk of Gastric Aspiration
4. BMI>30
5. Pregnant female
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
Primary Outcome
|
Outcome |
TimePoints |
Pressor response to laryngoscopy with video laryngoscope & conventional direct laryngoscope-systolic BP, Diastolic BP, mean arterial pressure, heart rate |
Baseline, at 1-minute 3, 5 10 & 15 minutes after endotracheal intubation |
|
Secondary Outcome
|
Outcome |
TimePoints |
1.To compare duration of laryngoscopy with video laryngoscope & conventional direct laryngoscope for patients requiring endotracheal intubation for general anaesthesia.
2.Complications related to intubation
|
Baseline, at 1-minute 3, 5 10 & 15 minutes after endotracheal intubation |
|
Target Sample Size
|
Total Sample Size="100" Sample Size from India="100"
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)
|
01/06/2023 |
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
|
The study will be published in indexed medical journal after completion |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
Direct Laryngoscopy is the most common technique used for tracheal intubation. In recent years, video laryngoscope has been developed and provide better laryngoscopic view. These devices also claimed that because of lower lifting force, it would generate a less hemodynamic response during intubation period. This Randomized, Prospective, comparative study is planned to compare pressor response to laryngoscopy with video laryngoscope & conventional direct laryngoscope along with duration of laryngoscopy in patients requiring general anaesthesia with endotracheal intubation. Total 100 patients of both genders posted for elective surgery under GA, age 18-60 years, BMI<30, ASA Grade I & II, Mallampatti Grade - I & II will be enrolled. Standard technique will be uses for induction of anaesthesia. Systolic BP, diastolic BP, mean arterial pressure & heart rate will be noted serially as baseline (T1), after premedication (T2), post induction, (T3) And post intubation (T4) post intubation at 1-minute (T5) 3-minute(T6) 5minute (T7) 10-minute(T8)15 minute (T9). An independent observer will note the hemodynamic parameters & duration of intubation. Data will be presented as mean (SD) for continuous variables, percentage for categorical variables & analysed with appropriate statistical test using SPSS version 16.0. |