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CTRI Number  CTRI/2024/07/070232 [Registered on: 09/07/2024] Trial Registered Prospectively
Last Modified On: 29/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To assess and compare Video Laryngoscopy versus Conventional Laryngoscopy during endotracheal intubation by comparing the time taken for endotracheal intubation in seconds in patients undergoing Surgery under General Anaesthesia 
Scientific Title of Study   Study to compare time taken to intubate with Videolaryngoscopy versus Conventional laryngoscopy in adult patients undergoing Surgery under General Anesthesia- Prospective randomized study at SMS medical college and attached group of hospital, Jaipur 
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 Harpreet Kaur 
Designation  Senior Professor 
Affiliation  Sawai Man Singh Medical College and attached Hospitals 
Address  Department of Anaesthesia, Sawai Man Singh Medical College and Attached Hospitals
Jawahar Lal Nehru Marg, Jaipur
Jaipur
RAJASTHAN
302004
India 
Phone  9899785993  
Fax    
Email  rupihar@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Harpreet Kaur 
Designation  Senior Professor 
Affiliation  Sawai Man Singh Medical College and Attached Hospitals 
Address  Department of Anaesthesia, Sawai Man Singh Medical College and attached Hospitals
Jawahar Lal Nehru Marg, Jaipur

RAJASTHAN
302004
India 
Phone  9899785993  
Fax    
Email  rupihar@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Pankaj Maurya 
Designation  Resident Doctor 
Affiliation  Sawai Man Singh Medical College and Attached Hospitals 
Address  Department of Anaesthesia, Sawai Man Singh Medical College and attached Hospitals
Jawahar Lal Nehru Marg, Jaipur
Jaipur
RAJASTHAN
302004
India 
Phone  9928019924  
Fax    
Email  mauryapankaj84@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesia, Sawai Man Singh Medical College and Attached Hospitals, Jaipur 
 
Primary Sponsor  
Name  Department of Anaesthesia Sawai Man Singh Medical College and Attached Hospitals 
Address  Department of Anaesthesia, Sawai Man Singh Medical College and Attached Hospitals, Jaipur Rajasthan 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Harpreet Kaur  Sawai Man Singh Medical College and attached Hospitals  Department of Anaesthesia, Dhanwantri Block Second Floor
Jaipur
RAJASTHAN 
9899785993

rupihar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ofiice of Ethics Committee Sawai Man Singh Medical College and Attached Hospitals,Jaipur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K800||Calculus of gallbladder with acutecholecystitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Conventional Laryngoscope  Time taken for endotracheal intubation in seconds 
Comparator Agent  Video Laryngoscope  Time taken for Endotracheal Intubation in seconds 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1.Adult patients undergoing elective Surgery under General Anaesthesia.
2.Patients having American Society of Anesthesiologist (ASA) physical status I and II..
3.Patients consenting to participate.
4.Patients with Mallampati grade 1 or 2. 
 
ExclusionCriteria 
Details  1.Patient refusal.
2.Patient should not be a part of other study
3.Patient with anticipated difficult intubation
4.Patients having oxygen saturation less than 92% after bag and mask ventilation with 100% oxygen
5.Patient with known risk of Aspiration
6.Emergency surgery 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1.Mean Total Intubation time in Seconds
2.Mean Ease of intubation score
3.Mean Modified Cormack Lehane grading
5.Mean Haemodynamic parameters :Systolic Blood Pressure(SBP), Diastolic Blood Pressure(DBP), Mean Arterial Pressure(MAP), Heart Rate(HR) 
1. Baseline
2. After Induction
3. 1min after induction
4. 5 min after induction 
 
Secondary Outcome  
Outcome  TimePoints 
N/A  N/A 
 
Target Sample Size   Total Sample Size="88"
Sample Size from India="88" 
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   Post Marketing Surveillance 
Date of First Enrollment (India)   15/07/2024 
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="0"
Months="2"
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  

Direct laryngoscopy is most widely used method of oro-tracheal intubation but at times it could be difficult, and may lead to adverse effect on cardiovascular system. Video laryngoscopy in contrast provides better visualization of airway making oro-tracheal intubation easy. In this study we will compare the use of Video laryngoscope (Group A) versus the macintosh (direct) laryngoscope blade (Group B) for routine airway management. 88 ASA grade 1 and grade 2 patients between the age of 18 and 60 yrs scheduled for elective laparoscopic cholecystectomy surgery will be included in the study. Informed written consent will be taken in the vernacular language. Premedication with injection (Inj) glycopyrolate 0.2 mg intravenous(i.v) 10 mins before + Inj. midazolam 0.02mg/kg i.v. 10 mins and (inj) metoclopramide 10mg i.v. 10mins before  + injection fentanyl 2mcg/kg i.v. will be given. All the patients will be preoxygenated with 100% oxygen through a face mask for three minutes, then general anesthesia will be induced with intravenous administration of inj. propofol (2 mg/kg), and inj Succinylcholine (2 mg/kg) Then patients will be randomly divided into 2 groups. Group  A (n=44) will be intubated using video laryngoscope (indirect) and Group B (n=44) will be intubated using direct laryngoscope (Macintosh) In the group A, an intubating stylet will be used. The oro-tracheal intubation will be carried out. Time taken for tracheal intubation procedure, visualization of airway, Haemodynamic parameters (Systolic BP, diastolic BP, mean arterial pressure, heart rate) will be assessed at numerous intervals as follow: baseline, after induction of anesthesia, one and five minutes after intubation.

 
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