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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  
self 
 
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  
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 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  
Status 
Not Applicable 
 
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.

 
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