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CTRI Number  CTRI/2025/07/090543 [Registered on: 09/07/2025] Trial Registered Prospectively
Last Modified On: 17/07/2025
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   Effect of 180 Degree Rotation Technique Versus Conventional Intubation on Postoperative Sore Throat in Adult patients Undergoing General Anaesthesia 
Scientific Title of Study   Comparison Between Incidence of Post Operative Sore Throat with Conventional Intubation and 180 Degree Rotation of Endotracheal Tube During Intubation in Adult Patient Under General Anaesthesia 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Kundan Kumar Jangir 
Designation  Post graduate student  
Affiliation  ABVIMS and Dr RML Hospital New Delhi  
Address  Room number 301 3rd floor Department of Anaesthesia ABVIMS and Dr RML Hospital Central Delhi 110001 India

Central
DELHI
110001
India 
Phone  9079718509  
Fax    
Email  kundanjangir207@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Sanjeev Sharma 
Designation  Professor  
Affiliation  ABVIMS and Dr RML Hospital New Delhi  
Address  Room number 301 3rd floor Department of Anaesthesia ABVIMS and Dr RML Hospital central Delhi 110001 India

Central
DELHI
110001
India 
Phone  9873768774  
Fax    
Email  drss21@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Sanjeev Sharma 
Designation  Anaesthesia  
Affiliation  ABVIMS and Dr RML Hospital New Delhi  
Address  Room number 301 3rd floor Department of Anaesthesia ABVIMS and Dr RML Hospital central Delhi 110001 India

Central
DELHI
110001
India 
Phone  9873768774  
Fax    
Email  drss21@yahoo.com  
 
Source of Monetary or Material Support  
ABVIMS and Dr RML Hospital Baba Kharak Singh Marg Near Gurudwara Bangla Sahib Connaught Place New Delhi 110001 Central Delhi  
 
Primary Sponsor  
Name  NIL 
Address  NIL 
Type of Sponsor  Other [] 
 
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 Kundan Kumar Jangir   ABVIMS and Dr RML Hospital New Delhi   Room no 301 3rd floor Department of Anaesthesia ABVIMS and Dr RML Hospital 110001 New Delhi India
Central
DELHI 		 9079718509

kundanjangir207@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee ABVIMS and Dr RML Hospital New Delhi   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Healthy Human Volunteers  Medical and surgical  
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Intubation using 180 degree rotation of Endotracheal tube   Comparison between incidence of postoperative sore throat in conventional intubation and 180 degree rotation of Endotracheal tube during intubation  
Intervention  Nil  Nil 
Comparator Agent  Oral Conventional Intubation   Comparison of incidence of postoperative sore throat in conventional intubation and 180 degree rotation of Endotracheal tube during intubation  
Comparator Agent  Oral Endotracheal intubation   conventional intubation and 180 degree rotation of Endotracheal tube during intubation 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  ASA l-lll
Patient undergoing general anaesthesia with an Endotracheal tube placement
Age more than 18 years
Ability to communicate pain in the postoperative period  
 
ExclusionCriteria 
Details  Pre existing sore throat, upper respiratory tract infection or recent cold with in 2 weeks
Pregnant women
Surgery involving pharynx larynx and vocal cord
More than one attempt of intubation
History of lung disease
Difficult airway  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Incidence of postoperative sore throat assess by sore throat grading
 		 At baseline
 
 
Secondary Outcome  
Outcome  TimePoints 
Severity of postoperative sore throat at different time intervals after extubation
Assessment of Hemodynamic parameters HR, SBP, DBP,MAP after intubation
Duration of surgery  		 At baseline  
 
Target Sample Size   Total Sample Size="250"
Sample Size from India="250" 
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 4 
Date of First Enrollment (India)   25/07/2025 
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
Modification(s)  		 Years="1"
Months="5"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  
GROUP C , patients intubated by conventional method of intubation.
GROUP R , patients intubated by 180 degree rotation of endotracheal tube during intubation.
After shifting the patient to the operating room, patient will be placed in supine position and
standard monitors will be attached including heart rate , electrocardiogram , non
invasive blood pressure monitor and pulse oximetry. Pre-oxygenation will be done
with 100 percent Oxygen for 3 minutes. Induction will be done with inj. midazolam 1mg, inj.
propofol 2 mg per kg , inj. fentanyl 2 mcg per kg, inj. vecuronium 0.1mg per kg intravenously.
Appropriate size of endotracheal tube will be chosen according to the age of the patient.
Patient will be placed in the supine position with the head in sniffing position to facilitate
optimal alignment of the oral pharyngeal and laryngeal axis. After achieving adequate depth of anaesthesia and ensuring jaw relaxation, the endotracheal tube inserted using MacIntosh
laryngoscope by conventional method and 180 degree clockwise rotation of endotracheal
tube when tip of endotracheal tube just enters in glottis. Correct positioning will be confirmed
by observing bilateral chest movement, five point auscultation of breath sounds and the
presence of a square wave capnography. The patient will be ventilated using oxygen plus nitrous
oxide or Air plus sevoflurane until MAC 0.8 to 1.2 is achieved. Further course of anaesthesia will
proceed as per standard protocols keeping in mind need of the patient,  and surgery.
At the end of the surgery, neuromuscular blockade will be reversed using intravenous
neostigmine 0.05mg per kg and glycopyrrolate 0.01mg per kg. After confirming adequate reversal of
neuromuscular blockade and return of spontaneous respiration, the endotracheal tube will be
removed once the patient is awake, obeying verbal commands and able to maintain a patent
airway. The patient will be then shifted to the post op recovery room. In cases where
endotracheal tube removal is not performed due to clinical or surgical reasons, the patient
will be excluded from the study to maintain consistency in outcome assessment.
 
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