FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2023/07/055886 [Registered on: 31/07/2023] Trial Registered Prospectively
Last Modified On: 20/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Descriptive 
Study Design  Other 
Public Title of Study   observing the intravenous drugs ketamine, dexmeditomidine and combination of ketamine of dexmeditomidine in the mitigation of agitation following general anaesthesia in patients undergoing nasal surgeries 
Scientific Title of Study   Comparison of ketamine, dexmedetomidine, ketodex in prevention of emergence agitation in adults undergoing nasal surgery 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  John Mammen 
Designation  Junior resident 
Affiliation  Kasturba Medical College,Manipal 
Address  Department of anesthesiology, Kasturba medical college, Manipal 576104

Udupi
KARNATAKA
576104
India 
Phone  9780062351  
Fax    
Email  karun.2393@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Rama Rani K 
Designation  Associate professor  
Affiliation  Kasturba Medical College,Manipal 
Address  Department of anaesthesiology, Kasturba medical college, Manipal, Udupi,Karnataka

Udupi
KARNATAKA
576104
India 
Phone  9902938044  
Fax    
Email  rama.rani@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Rama Rani K 
Designation  Associate professor  
Affiliation  Kasturba Medical College,Manipal 
Address  Department of anaesthesiology, Kasturba medical college, Manipal, Udupi,Karnataka

Udupi
KARNATAKA
576104
India 
Phone  9902938044  
Fax    
Email  rama.rani@manipal.edu  
 
Source of Monetary or Material Support  
Department of Anaesthesiology,Kasturba Medical College,Manipal 
 
Primary Sponsor  
Name  John Mammen 
Address  Department of anaesthesiology,Kasturba medical college,MAHE, Manipal 
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 John Mammen  Kasturba medical college   Department of Anaesthesiology,Kasturba medical college,Madhav nagar, Manipal,Udupi-576104 Udupi KARNATAKA
Udupi
KARNATAKA 
9780062351

karun.2393@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
kasturba medical college and Kasturba hospital institutional ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J30-J39||Other diseases of upper respiratory tract,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Patients of either sex scheduled for elective nasal surgeries under general anaesthesia
-American society of Anesthesiologists physical status I,II
 
 
ExclusionCriteria 
Details  Patients with altered mental status
Patients on psychoactive/analgesics/ Beta agonist drugs
Pregnant women
Patient with known allergy or hypersensitivity to the drugs used in the study
Patients with anticipated difficult airway
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare the level of emergence agitation in patients receiving ketamine, dexmedetomidine
and ketodex atrecovery from general anaesthesia & admission to post anaesthesia care unit, Hemodynamic parameters, post operative nausea vomiting, pain score
 
Level of agitation assessed by Riker Sedation Agitation scale, At recovery & at admission to PACU. hemodynamic parameters, postoperative nausea vomiting and pain scores every 15 minutes till 30 minutes, followed by every 30 minutes for 2 hours at post operative anaesthesia care unit 
 
Secondary Outcome  
Outcome  TimePoints 
Level of pain  Will be assessed by Numeric pain rating scale at admission to postoperative anaesthesia care unit & at discharge from postoperative anaesthesia care unit. 
Hemodynamic parameters  every 15 minutes till 30 minutes, followed by every 30 minutes for 2 hours at post operative anaesthesia care unit
 
Post operative nausea vomiting:  assessed by 4 Point Post operative nausea & vomiting scale at admission to post operative care unit and at discharge from post operative care unit
 
Discharge time in minutes  The time from arrival to post-anaesthesia care unite (PACU) to discharge to the ward according to modified Aldrete score 
Extubation time  Time from discontinuing sevoflurane to extubation. 
Recovery time  Time in minutes from when sevoflurane is discontinued,to response to first verbal command 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   10/08/2023 
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="4"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Yet Recruiting 
Recruitment Status of Trial (India)  Open to Recruitment 
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  

Emergence agitation is a common side effect seen following nasal surgeries. Emergence agitation involves restlessness, disorientation, excitation, non-purposeful movement, inconsolability, thrashing, and incoherence during early recovery from general anaesthesia and can cause injury to patients and unwanted accidents in the operation theatre and post anaesthesia care unit. Various drugs have been used to decrease the incidence of emergence agitation following nasal surgeries.We are comparing the effects of three drugs ketamine, dexmedetomidine and a combination of ketamine and dexmedetomidine ie; ketodex which are routinely used to ameliorate or prevent emergence agitation, by comparison of recovery characteristics including extubation and Recovery time( Time in minutes from when inhalation agent is discontinued,to response to first verbal command);Level of agitation assessed by Riker Sedation Agitation Scale,level of pain will be assessed by Numeric pain rating scale;Hemodynamic parameters will be compared at regular intervals  at post operative anaesthesia care unit;Post operative nausea vomiting will be assessed by 4 Point Post operative nausea and vomiting scale ;and Discharge time at arrival to post-anaesthesia care unite (PACU) to discharge to the ward according to modified Aldrete score, patients having Aldrete score of 9 or higher will be discharged to the ward.

 
Close