| CTRI Number |
CTRI/2024/11/077152 [Registered on: 20/11/2024] Trial Registered Prospectively |
| Last Modified On: |
19/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
POST-OPERATIVE SORE THROAT: COMPARING KINGVISION VIDEO LARYNGOSCOPE AND MACINTOSH LARYNGOSCOPE FOR ADULT PATIENTS REQUIRING GENERAL ANESTHESIA |
|
Scientific Title of Study
|
POST-OPERATIVE SORE THROAT: COMPARING KINGVISION VIDEO LARYNGOSCOPE AND MACINTOSH LARYNGOSCOPE FOR ADULT PATIENTS REQUIRING TRACHEAL 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 |
Dr PRIYANKA N H |
| Designation |
POST GRADUATE RESIDENT |
| Affiliation |
KODAGU INSTITUTE OF MEDICAL SCIENCES AND TEACHING HOSPITAL,MADIKERI |
| Address |
DEPARTMENT OF ANESTHESIOLOGY
KODAGU INSTITUTE OF MEDICAL SCIENCES AND TEACHING HOSPITAL,NEAR GT CIRCLE,MADIKERI
Kodagu
KARNATAKA
571201
India |
| Phone |
8073386171 |
| Fax |
|
| Email |
priyankanh071997@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR AIYAPPA D S |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
KODAGU INSTITUTE OF MEDICAL SCIENCES AND TEACHING HOSPITAL,MADIKERI |
| Address |
DEPARTMENT OF ANESTHESIOLOGY
KODAGU INSTITUTE OF MEDICAL SCIENCES AND TEACHING HOSPITAL
MADIKERI
Kodagu
KARNATAKA
571201
India |
| Phone |
9986336771 |
| Fax |
|
| Email |
draiyappads@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR AIYAPPA D S |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
KODAGU INSTITUTE OF MEDICAL SCIENCES AND TEACHING HOSPITAL,MADIKERI |
| Address |
DEPARTMENT OF ANESTHESIOLOGY
KODAGU INSTITUTE OF MEDICAL SCIENCES AND TEACHING HOSPITAL
MADIKERI
Kodagu
KARNATAKA
571201
India |
| Phone |
9986336771 |
| Fax |
|
| Email |
draiyappads@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kodagu Institute Of Medical Sciences and Teaching Hospital,Madikeri 571201 |
|
|
Primary Sponsor
|
| Name |
Kodagu Institute Of Medical Sciences and Teaching Hospital Madikeri |
| Address |
Kodagu Institute Of Medical Sciences and Teaching Hospital Madikeri 571201 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| PRIYANKA N H |
Kodagu Institute Of Medical Sciences and Teaching Hospital Madikeri |
Department Of Anesthesiology Kodagu Institute Of Medical Sciences and Teaching Hospital Madikeri 571201
Kodagu
KARNATAKA |
8073386171
priyankanh071997@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,Kodagu Institute of Medical Sciences,Madikeri |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Laryngoscopy and intubation |
Endotracheal intubation done using Macintosh laryngoscope in MCL group
|
| Intervention |
Laryngoscopy and intubation by kingvision video laryngoscope |
Endotracheal intubation done using kingvision video laryngoscope in VDL group |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing surgery under general anesthesia
1.ASA PS grade 1 and 2
2.Mallampati classification 1 and 2
3.BMI less than 30kg/m2 |
|
| ExclusionCriteria |
| Details |
1.Duration of surgery more than 4 hours
2.Recent upper respiratory tract infection
3.Patients requiring throat pack insertion
|
|
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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 |
| To compare incidence of postoperative sore throat(POST) after laryngoscopy and intubation using Macintosh laryngoscope and Kingvision video laryngoscope |
Incidence of sore throat- At 0th ,1st, 6th , 12th , 24th hour |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The severity of POST during first 24hours after surgery. |
Severity of sore throat-At 0th, 1st, 6th , 12th , 24th hour |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
30/11/2024 |
| 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="1"
Months="6"
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
|
POST-OPERATIVE SORE THROAT: COMPARING KINGVISION VIDEO LARYNGOSCOPE AND MACINTOSH LARYNGOSCOPE FOR ADULT PATIENTS REQUIRING TRACHEAL INTUBATION. On previous day of surgery, all patients will have pre anesthetic evaluation. Patient’s airway will be evaluated using modified Mallampati classification and airway evaluating parameters like inter incisor distance, thyromental distance, sternomental distance. Patients who meet the inclusion criteria will be randomly assigned to two equal groups. Group MCL: Endotracheal intubation done using Macintosh laryngoscope. Group VDL : endotracheal intubation done using king vision video laryngoscope On the day before surgery the patients will be explained how to rate the severity of POST by using a 04 point scale (0-3).The incidence of POST Will be recorded using a yes/no questionnaire. On the day of surgery, written informed consent will be obtained from all patients. Patient shifted to Operation theatre and standard multipara monitors are connected. IV access with 20G cannula will be established. Patients will be premedicated with injection injection Midazolam 0.02mg/kg , injection Fentanyl 2mcg/kg induction with injection Propofol 1-2 mg/kg , muscle relaxant with Vecuronium 0.1mg/kg. Patient in group MCL will be intubated with laryngoscope size 3 or 4 blade. Similarly, patients in group VDL Size 4 reusable blade will be used. Patients will be intubated with 7 and 8 mm endotracheal tube in women and men respectively. Pressure will be maintained between 20-25 cm of water, measured using portex cuff manometer. . Once the patient is intubated the observer will enter the Operation Theatre. General Anaesthesia will be maintained by 2% Sevoflurane on completion of surgery reversal with mixture of inj. Neostigmine 0.05mg/kg and Glycopyrolate 0.01mg/kg will be administered. Post extubation vitals noted. Once the patient is shifted to Post Anaesthesia Care Unit, patient will be asked by observer about incidence of POST and will be labelled as time 0 hr. Then, at 1st hour,6th hour,12thhour and at 24th hour. The data collected will be summarized and compiled. It will be entered into Microsoft Excel spreadsheet and then exported to data editor of SPSS version 26.0.Results will be expressed using charts and tables.
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