CTRI Number |
CTRI/2017/12/011009 [Registered on: 28/12/2017] Trial Registered Retrospectively |
Last Modified On: |
19/12/2017 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Surgical/Anesthesia |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
Ketamine nebulisation in Post-operative sore throat |
Scientific Title of Study
|
Dose-dependent effectiveness of Ketamine nebulisation in preventing post-operative sore throat due to tracheal intubation: A Prospective Randomised Controlled Trial. |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Madhava Reddy R |
Designation |
Professor |
Affiliation |
Kempegowda Institute of Medical Sciences, Bangalore |
Address |
Major OT complex, 4th floor,
Department of Anaesthesiology, KIMS Hospital, Bangalore
Bangalore KARNATAKA 560004 India |
Phone |
9379094790 |
Fax |
|
Email |
madhavareddy.r@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Madhava Reddy R |
Designation |
Professor |
Affiliation |
Kempegowda Institute of Medical Sciences, Bangalore |
Address |
Major OT complex 4th floor,
Department of Anaesthesiology, KIMS Hospital, Bangalore
Bangalore KARNATAKA 560004 India |
Phone |
9379094790 |
Fax |
|
Email |
madhavareddy.r@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Madhava Reddy R |
Designation |
Professor |
Affiliation |
Kempegowda Institute of Medical Sciences, Bangalore |
Address |
Major OT complex 4th floor,
Department of Anaesthesiology, KIMS Hospital, Bangalore
Bangalore KARNATAKA 560004 India |
Phone |
9379094790 |
Fax |
|
Email |
madhavareddy.r@gmail.com |
|
Source of Monetary or Material Support
|
|
Primary Sponsor
|
Name |
Dr Madhava Reddy R |
Address |
Major OT complex, 4th floor, Department of Anaesthesiology, KIMS Hospital, Bangalore |
Type of Sponsor |
Other [self ] |
|
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 |
Dr Madhava Reddy |
Kempegowda Institute Of Medical Sciences |
Major OT Anaesthesiology, KIMS Hospital, Bangalore complex, 4th floor, Department of Anaesthesiology, V V Puram, Bangalore 560004
Bangalore KARNATAKA |
9379094790 9379094790 madhavareddy.r@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
KIMS-IEC |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
post operative sore throat , |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
preservative free Ketamine |
1 mg/kg, Aneket 50 mg/ml, 2ml ampoule, Neon Laboratories Ltd |
Comparator Agent |
preservative free Ketamine |
1.5 mg/kg, Aneket 50 mg/ml, 2ml ampoule, Neon Laboratories Ltd |
Intervention |
preservative free Ketamine |
0.5 mg/kg, Aneket 50 mg/ml, 2ml ampoule, Neon Laboratories Ltd |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
1. ASA physical status 1 and 2
2. patients undergoing surgeries in supine position under general Anaesthesia
3. surgeries lasting more than one hour |
|
ExclusionCriteria |
Details |
1. Patients with Mallampati class greater than 2
2. pre-operative sore throat,
3. allergy to study drug,
4. recent history of NSAID medication,
5. smokers, asthmatics, patients with COPD, 6.head and neck surgeries,
7.those who require more than two attempts at intubation,
8.surgeries requiring nasogastric tube and throat pack insertion.
9.Patients in whom extubation caused coughing or bucking. |
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
Primary Outcome
|
Outcome |
TimePoints |
post operative sore throat at 4 hours |
4 hours |
|
Secondary Outcome
|
Outcome |
TimePoints |
post operative sore throat at 0, 2, 6,8, 12, 24 hours |
0, 2, 6,8, 12, 24 hours |
|
Target Sample Size
|
Total Sample Size="90" Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "90"
Final Enrollment numbers achieved (India)="90" |
Phase of Trial
|
N/A |
Date of First Enrollment (India)
|
20/11/2015 |
Date of Study Completion (India) |
15/05/2017 |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
15/05/2017 |
Estimated Duration of Trial
|
Years="0" Months="6" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Completed |
Publication Details
|
accepted for publication in Sri Lankan Journal of Anaesthesia |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
Background : Sore throat is a common and distressing post operative complication following endotracheal intubation that contributes to patient discomfort. Several pharmacological and non-pharmacological methods may be used to attenuate post-operative sore throat. In literature there is no study evaluating dose-dependent effectiveness of ketamine nebulisation, neither has there been a study to assess patient acceptability with ketamine nebulisation. The prime objective of this study was to assess graded doses of ketamine nebulization in attenuation of post-operative sore throat and patient acceptability and satisfaction. Materials and Methods: 90 patients between age group of 18 and 60 years of ASA physical status 1 and 2 of either sex undergoing surgeries in supine position under general anaesthesia lasting for more than one hour were randomly allocated into three groups. Group A received 0.5 mg/kg, group B received 1 mg/kg and group C received 1.5mg/kg body weight of nebulized preservative free ketamine for 15 minutes, 5 minutes before intubation. The patients were then assessed for acceptability to ketamine nebulization. At the end of the surgery post-operative sore throat was assessed at 0, 2, 4, 6, 8, 12 and 24 hours. Results: Nebulized ketamine at a dose of 0.5 mg/kg was comparatively less effective than 1 mg/kg and 1.5 mg/kg and the difference was statistically significant. 1 mg/kg and 1.5 mg/kg of nebulized ketamine are better and equally effective in reducing the incidence and severity of post-operative sore throat. There was no statistical difference in the acceptability scores to the different doses of nebulised ketamine. Conclusion: Nebulized ketamine is well accepted by all patients and effective in reducing the severity of post-operative sore throat without any untoward effects. However larger population estimation of serum ketamine levels is needed to find out a better dose of ketamine for nebulization to prevent the incidence and severity of post-operative sore throat. |