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
|
|
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
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: J30-J39||Other diseases of upper respiratory tract, |
|
Intervention / Comparator Agent
|
|
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. |