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CTRI Number  CTRI/2025/10/096492 [Registered on: 27/10/2025] Trial Registered Prospectively
Last Modified On: 24/10/2025
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 clinical study to compare the hemodynamic response to intubation(increase in Blood pressure and increase in heart rate) between C-MAC® video laryngoscope and C-MAC® video stylet(two types of intubation devices) in hypertensive patients scheduled for elective surgery under general anesthesia 
Scientific Title of Study   Hemodynamic response to endotracheal intubation with C-MAC® video laryngoscope versus C-MAC® video stylet in patients with controlled hypertension scheduled for elective surgery under general anesthesia -A randomized controlled trial 
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 Rupali Swami 
Designation  Post Graduate First Year Resident 
Affiliation  Lady Hardinge Medical College and associated hospitals 
Address  Department of Anaesthesia,5th floor (Academic Block) Lady Hardinge Medical College and associated hospitals,Shaheed Bhagat Singh Road, Connaught Place, DIZ Area, New Delhi

Central
DELHI
1100001
India 
Phone  9711883169  
Fax    
Email  rupaliswamy@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Ranju Singh 
Designation  Director Professor & Head 
Affiliation  Lady Hardinge Medical College and associated hospitals 
Address  Lady Hardinge Medical College and associated hospitals,Shaheed Bhagat Singh Road, Connaught Place, DIZ Area, New Delhi

Central
DELHI
110001
India 
Phone  9811151285  
Fax    
Email  ranjusingh1503@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Rupali Swami 
Designation  Post Graduate First Year Resident 
Affiliation  Lady Hardinge Medical College and associated hospitals 
Address  Department of Anaesthesia,5th floor (Academic Block) Lady Hardinge Medical College and associated hospitals,Shaheed Bhagat Singh Road, Connaught Place, DIZ Area, New Delhi

Central
DELHI
110001
India 
Phone  9711883169  
Fax    
Email  rupaliswamy@gmail.com  
 
Source of Monetary or Material Support  
Lady Hardinge Medical College and associated hospitals 
 
Primary Sponsor  
Name  Lady Hardinge Medical College and associated hospitals 
Address  Lady Hardinge Medical College and associated hospital,Shaheed Bhagat Singh Road, Connaught Place, DIZ Area, New Delhi,Delhi-110001, India 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 4  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Rupali Swami  Lady Hardinge Medical College and associated hospitals  Surgery OT (eighth floor) Emergency building Lady Hardinge Medical College and associated hospitals, Shaheed Bhagat Singh Road, Connaught Place, DIZ Area, New Delhi
Central
DELHI 
09711883169

rupaliswamy@gmail.com 
Dr Rupali Swami  Lady Hardinge Medical College and associated hospitals  Orthopaedics OT (First floor) Lady Hardinge Medical College and associated hospitals, Shaheed Bhagat Singh Road, Connaught Place, DIZ Area, New Delhi
Central
DELHI 
09711883169

rupaliswamy@gmail.com 
Dr Rupali Swami  Lady Hardinge Medical College and associated hospitals  Eye/ ENT OT (Seventh Floor) Lady Hardinge Medical College and associated hospitals, Shaheed Bhagat Singh Road, Connaught Place, DIZ Area, New Delhi
Central
DELHI 
09711883169

rupaliswamy@gmail.com 
Dr Rupali Swami  Lady Hardinge Medical College and associated hospitals  Gynaecology OT,Old Building first floor, Lady Hardinge Medical College and associated hospitals, Shaheed Bhagat Singh Road, Connaught Place, DIZ Area, New Delhi
Central
DELHI 
09711883169

rupaliswamy@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee for Human Research, LHMC and associated Hospitals,New Delhi-110001  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: I10||Essential (primary) hypertension, (3) ICD-10 Condition: I159||Secondary hypertension, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Hemodynamic response (heart rate, blood pressure) to endotracheal intubation using the C-MAC® video laryngoscope in patients with controlled hypertension scheduled for elective surgery under general anaesthesia  After induction of general anaesthesia patient will be intubated using C-MAC® video laryngoscope.Intubation time, POGO score and hemodynamic parameters (HR, SBP and DBP) will be recorded at baseline, pre-intubation, and 1, 3, and 5 minutes post-intubation. Any orodental trauma, intubation attempts, and required manoeuvres (e.g., OELM) will be noted.  
Comparator Agent  Hemodynamic response(heart rate, blood pressure) to endotracheal intubation with C-MAC® video stylet in patients with controlled hypertension scheduled for elective surgery under general anesthesia  After induction of general anaesthesia patient will be intubated using C-MAC® video stylet. Intubation time, POGO score and hemodynamic parameters (HR, SBP and DBP) will be recorded at baseline, pre-intubation, and 1, 3, and 5 minutes post-intubation. Any orodental trauma, intubation attempts, and required manoeuvres (e.g., OELM) will be noted. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Adults belonging to the age group 18-60 years with controlled hypertension on antihypertensive therapy, without any other
comorbidities (asthma/chronic obstructive pulmonary disease/diabetes mellitus/renal
dysfunction/active liver disease)posted for Elective surgical procedures under general anaesthesia  
 
ExclusionCriteria 
Details  1.Patients with Anticipated difficult airway(Mallampati classification III/IV),anatomical upper airway abnormality, cervical spine instability,restricted mouth opening, limited neck mobility
2 morbid obesity (BMI more than 30)
3.ischemic heart disease,cardiac arrythmias,significant heart disease
4. pregnant or lactating women
5. patients on beta blockers or clonidine 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Mean (± SD) change in SBP (mmHg) and HR (bpm) in patients with endotracheal
intubation via C-MAC® Video Laryngoscope and C-MAC® Video Stylet recorded at 1,3 and 5 minutes after
endotracheal intubation from baseline (induction) 
Mean (± SD) change in SBP (mmHg) and HR (bpm) in patients with endotracheal
intubation via C-MAC® Video Laryngoscope and C-MAC® Video Stylet recorded at 1,3 and 5 minutes after
endotracheal intubation from baseline (induction) 
 
Secondary Outcome  
Outcome  TimePoints 
Median (interquartile range (IQR) POGO score   Assessed at the time of intubation 
Proportion of patients requiring OELM for achieving successful intubation.   Assessed at the time of intubation 
Mean (± SD) time taken in seconds for tracheal intubation  Time from introduction of laryngoscope top the appearance of first square wave capnographic trace in first attempt 
Proportion of patients in whom successful intubation could be achieved  Assessed at the time of intubation 
Proportion of patients identified with orodental trauma.  Assessed at the time of intubation 
Mean (± SD) difference in serum cortisol levels 2 minutes after intubation from
the baseline levels 
Assessed at the time of intubation & 2 minutes post intubation 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   07/11/2025 
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="3"
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   METHODOLOGY 
The study will be conducted only after approval from the Institutional Ethical Committee (IEC) and will be registered with Clinical Trials Registry India (CTRI). A detailed pre-anesthetic check-up will be done for all patients. A written voluntary informed consent will be obtained for anaesthesia, surgery and participation in the study.
An anaesthesiologist with an experience of at least 20 successful endotracheal intubations with both the devices will perform the intubations. Patients will be randomised to one of the two groups:
Group VL: Intubation using the C-MAC video laryngoscope 
 Group VS: Intubation using the C-MAC video stylet  

Patients will be kept nil per oral (NPO) for 6 hours for solid foods, prior to surgery as per standard guidelines. Tablet alprazolam 0.25 mg will be given to all patients orally the night before surgery. Hypertensive patients shall receive the antihypertensive medication in the night before the surgery or on the morning of surgery as prescribed by the treating physician. After arrival in the operating room, an 18G or 20G peripheral intravenous catheter will be inserted. 
Standard monitoring will be applied, including non-invasive blood pressure (NIBP), electrocardiograph (ECG) with heart rate (HR) and pulse oximetry (SpO2) and baseline parameters will be recorded. A venous blood sample shall be obtained pre induction for baseline serum cortisol levels estimation. 
The appropriate device for intubation will be prepared. 
In group VL, the endotracheal tube shall be loaded with a stylet shaped in a hockey stick fashion while in group VS, the appropriately sized endotracheal tube shall be loaded on the well lubricated C-MAC VS.
Patients will be pre-oxygenated with 100% oxygen via a facemask for 3 minutes and anaesthesia will be induced intravenously with slow administration of injection (inj.) fentanyl 2 µg/Kg and inj. propofol 2 mg/Kg. After confirming adequate mask ventilation, inj. rocuronium 0.6 mg/Kg will be administered for neuromuscular blockade. Intermittent positive pressure ventilation will be continued with oxygen in air and 2% sevoflurane for 3 minutes. A venous sample will be obtained to estimate the serum cortisol levels pre intubation (which will be considered as baseline). The neuromuscular blockade will be monitored by the loss of the train of four (TOF) stimulation of the peripheral nerve, and intubation with a weight appropriate cuffed endotracheal tube will be done when a fully relaxed status is achieved (TOF 0/4).
Group VL: The VL will be positioned in the midline of the mouth, and the tip guided under vision towards the base of the tongue, then under monitor view towards the vallecula, allowing visibility of the glottic opening. Subsequently, close to the blade edge, the endotracheal tube over stylet will be advanced under direct vision, taking care to maintain the tube tip visibility at all times. The endotracheal tube will be advanced over the stylet immediately in front of the arytenoid cartilages with the assistance of monitor guidance
Group VS: The video stylet will be inserted into the endotracheal tube, and the tracheal tube will be fixed at the upper end to prevent the lens from sticking out of the tracheal tube and avoid contamination of the lens with secretions. After 11–12 cm (at the level of the upper larynx), the lens will be aimed to the left and middle of the neck while the screen is observed to locate the glottic opening. If required a jaw-thrust technique will be employed to create a pharyngeal space for visualization of laryngeal structures. The endotracheal tube will be advanced into the trachea, the core will be pulled out, the video stylet will be withdrawn. 

 The cuff of the endotracheal tube will be slowly inflated with air so that there is no leak at a peak airway pressure of 20 cmH2O. Adequate ventilation will be confirmed by bilateral chest movements and capnographic waveforms. 
 The hemodynamic parameters such as HR, SBP, DBP will be recorded at following time intervals: baseline, immediately pre intubation and 1-, 3- and 5-minutes post intubation. Percentage of glottic opening (POGO) score-(100% is Visualisation of entire glottis from anterior commissure of vocal cords to arytenoids and 0% is No glottic opening visualised) will be recorded. Any OELM required for successful intubation and the number of patients requiring application of OELM will be recorded. Time taken for tracheal intubation will be measured (in seconds) as the time from introduction of intubating device into the mouth to till the appearance of first square wave capnograph. Any evidence of orodental trauma in terms of injury to lips, teeth, gums, and mucosa of the oropharynx shall be observed while withdrawing the device after the endotracheal intubation is achieved. 
Failure of intubation shall be defined if more than three attempts are required to secure the airway. In such a situation, the airway will be secured as per the anesthesiologist discretion and the patient will be excluded from the study.
 Second venous blood sample shall be collected for estimation of serum cortisol levels at 2 minutes post intubation in plain red capped vacutainer. Both the sample tubes collected at pre induction and 2 minutes post intubation will be labelled appropriately and sample will be sent to lab for further processing. After clot formation, sample will be centrifuged at 1500 rpm for 5 minutes. The separated serum will be pipetted in labelled aliquots for storing at -20 degrees in deep freeze. Batch analysis of samples will be performed on DXI 800 immunoassay analyzer using kit method for estimation of serum cortisol levels.

After successful intubation the patients’ lungs will be ventilated with a mixture of oxygen in air with sevoflurane maintaining a minimum alveolar concentration (MAC) of 1.0-1.2, with the patient on controlled mechanical ventilation to maintain normocarbia. Electrocardiograph with HR, NIBP, SpO2, end tidal carbon dioxide (EtCO2), end tidal anaesthetic gas concentration, MAC and temperature will be monitored for all patients throughout. In case of severe hemodynamic response, the plane of anaesthesia will be deepened by increasing the concentration of inhalational anaesthetic agent and if required injection propofol will be administered intravenously in small aliquots of 10-20mg, if the hemodynamic response does not settle, then inj. labetalol 20mg intravenous bolus shall be administered slowly. The patient would be subsequently handed over for surgery.
 At the end of the surgery, anaesthesia will be terminated, neuromuscular blockade will be reversed and the patient’s trachea will be extubated. The patient will be then transferred to the post-anaesthesia care unit (PACU).   
 



 WHY IS THIS RESEARCH WORK NECESSARY?
 This study aims to fill this gap by comparing the hemodynamic responses and change in serum cortisol levels elicited by VL and VS when used for endotracheal intubation in patients with well-controlled hypertension undergoing elective surgery. By identifying the technique that produces a lesser pressor response, our study may support safer airway management strategies in hypertensive patients, ultimately contributing to improved perioperative outcomes. 
 
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