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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  
Status 
Not Applicable 
 
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.

 
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