CTRI

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CTRI Number

CTRI/2025/07/091505 [Registered on: 23/07/2025] Trial Registered Prospectively

Last Modified On:

22/07/2025

Post Graduate Thesis

Yes

Type of Trial

Observational

Type of Study

Cross Sectional Study

Study Design

Single Arm Study

Public Title of Study

Comparison of sore throat after surgery in different surgical positions

Scientific Title of Study

Comparison of post-operative sore throat (POST) in supine with non-supine positions in patients undergoing general anaesthesia with oral intubation

Trial Acronym

NIL

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Sandra Sarah Sabu
Designation	Postgraduate
Affiliation	Manipal College of Health Professions
Address	Anaesthesia and Operation Theatre Technology, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal Udupi KARNATAKA 576104 India
Phone	7994045823
Fax
Email	sandra.mchpmpl2024@learner.manipal.edu

Details of Contact Person
Scientific Query

Name	Dr Nisha Sara M Jacob
Designation	Associate Professor
Affiliation	Kasturba Medical College
Address	Department of Anaesthesia, Kasturba Medical College, Manipal, Manipal Academy of Higher Education, Manipal Udupi KARNATAKA 576104 India
Phone	919500574751
Fax
Email	nishasara@gmail.com

Details of Contact Person
Public Query

Name	Sandra Sarah Sabu
Designation	Postgraduate
Affiliation	Manipal College of Health Professions
Address	Anaesthesia and Operation Theatre Technology, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal Udupi KARNATAKA 576104 India
Phone	7994045823
Fax
Email	sandra.mchpmpl2024@learner.manipal.edu

Source of Monetary or Material Support

Kasturba Hospital,Udupi - Hebri Rd, Madhav Nagar, Manipal, Karnataka 576104

Primary Sponsor

Name	Sandra Sarah Sabu
Address	Anaesthesia and Operation Theatre Technology, 5th floor, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal, Karnataka, 576104
Type of Sponsor	Other [Self]

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 Nisha Sara M Jacob	Kasturba Hospital	Operation theatre complex,1st floor, Main OT Block, Manipal, Karnataka 576104 Udupi KARNATAKA	91 95005 74751 nishasara@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Institutional Ethics Committee-2(Student Research)	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,

Intervention / Comparator Agent

Type	Name	Details
Intervention	Nil	Nil
Intervention	Nil	Nil
Intervention	Nil	Nil

Inclusion Criteria

Age From	18.00 Year(s)
Age To	99.00 Year(s)
Gender	Both
Details	•Patients above the age of 18 years undergoing elective surgeries in general anaesthesia with oral intubation •American Society of Anesthesiologists Physical Status classification system: 1-4

ExclusionCriteria

Details

Surgeries involving the airway (nasal, oral and tracheal surgeries),Sitting position,Neurosurgery,Cardiothoracic surgery,Pregnant women,Nasotracheal intubation,Double lumen tube insertion planned,Postoperative nasogastric tube insertion planned,Patients having upper and lower respiratory tract infections(less than 2 weeks before surgery)

Method of Generating Random Sequence

Not Applicable

Method of Concealment

Not Applicable

Blinding/Masking

Not Applicable

Primary Outcome

Outcome	TimePoints
To observe the incidence of postoperative sore throat, hoarseness and difficulty in swallowing	2 hrs and 24 hrs after surgery during postoperative period

Secondary Outcome

Outcome	TimePoints
NIL	NIL

Target Sample Size

Total Sample Size="192"
Sample Size from India="192"
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)

02/08/2025

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="0"
Months="8"
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

Previous studies revolve around the repeated incidences of POST in patients receiving general anaesthesia during surgery.

The evaluation of postoperative sore throat is accomplished by comparing the cuff pressures at different time intervals and by interviewing patients for hoarseness, cough and POST pain during postoperative recovery period.

Cuff pressures(>20cm) H2O and cough at emergence time contributed to risk of postoperative sore throat, irrespective to surgical procedure or the type of endotracheal tube.

Increased duration of surgery, increased age of patients and larger size endotracheal tubes have an impact in the development of postoperative sore throat.

Increased cuff pressures were observed especially in the prone position during the surgical procedure.

There is a lack of literature on the incidence of POST in different positions in patients undergoing procedures under general anaesthesia.

This study aims to observe the incidence of postoperative sore throat in different surgical positions in patients undergoing elective procedures in general anaesthesia with endotracheal tubes.