CTRI Number |
CTRI/2024/03/063919 [Registered on: 11/03/2024] Trial Registered Prospectively |
Last Modified On: |
08/03/2024 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Drug |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
A clinical study to compare the effectiveness of reducing post operative sore throat in tonsillectomy following dexmedetomidine intraoral spray versus ketamine intraoral spray |
Scientific Title of Study
|
A comparative study to evaluate the attenuation of post operative sore throat in tonsillectomy following dexmedetomidine intraoral spray versus ketamine intraoral spray: A clinical study |
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 Ranadhee Paul |
Designation |
Assistant Professor, Department Of Anaesthesiology |
Affiliation |
Silchar Medical College And Hospital |
Address |
Department Of Anaesthesiology, Silchar Medical College And Hospital, P.O. Ghungoor, Silchar, Cachar , Assam
Cachar ASSAM 788014 India |
Phone |
7002334288 |
Fax |
|
Email |
binoy.bihari@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Ranadhee Paul |
Designation |
Assistant Professor, Department Of Anaesthesiology |
Affiliation |
Silchar Medical College And Hospital |
Address |
Department Of Anaesthesiology, Silchar Medical College And Hospital, P.O. Ghungoor, Silchar, Cachar, Assam
Cachar ASSAM 788014 India |
Phone |
7002334288 |
Fax |
|
Email |
binoy.bihari@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Ranadhee Paul |
Designation |
Assistant Professor, Department Of Anaesthesiology |
Affiliation |
Silchar Medical College And Hospital |
Address |
Department Of Anaesthesiology, Silchar Medical College And Hospital, P.O. Ghungoor, Silchar, Cachar, Assam
Cachar ASSAM 788014 India |
Phone |
7002334288 |
Fax |
|
Email |
binoy.bihari@gmail.com |
|
Source of Monetary or Material Support
|
Silchar Medical College And Hospital,Silchar, PIN 788014, Cachar, Assam |
|
Primary Sponsor
|
Name |
Dr Ranadhee Paul |
Address |
Department Of Anaesthesiology,Silchar Medical College And Hospital, P.O. Ghungoor, Silchar,Cachar,Assam, PIN 788014 |
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 Ranadhee Paul |
Silchar Medical College And Hospital |
Department Of Anaesthesiology, SMCH, Silchar, Cachar, Assam Cachar ASSAM |
7002334288
binoy.bihari@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethics Committee of Silchar Medical College And Hospital |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: J350||Chronic tonsillitis and adenoiditis, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Dexmedetomidine intraoral spray |
Dexmedetomidine intraoral spray(2mcg/kg) is given 2 minutes before intubation under direct laryngoscopy. |
Comparator Agent |
Ketamine intraoral spray |
Ketamine intraoral spray(25mg diluted in 2 cc saline) is given 2 minutes before intubation under direct laryngoscopy.
|
|
Inclusion Criteria
|
Age From |
12.00 Year(s) |
Age To |
30.00 Year(s) |
Gender |
Both |
Details |
1.Only ASA I and II without any anticipated difficult airway (MPS -I & II) will be included .
2.Patients between age 12-30 years
3.Patients of both sexes
4.Patients scheduled for elective tonsillectomy under general anaesthesia
|
|
ExclusionCriteria |
Details |
1.Refusal to valid informed consent.
2.History of allergy to the study drugs.
3. Patients with Cardiovascular, respiratory, renal , hepatic or neuromuscular diseases.
4. Patients with a history of preoperative sore throat, asthma, respiratory tract infection,consumption of analgesic in preoperative period, operating time more than 90 minutes, and requirement of more than one attempt for passage of endotracheal tube.
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Participant Blinded |
Primary Outcome
|
Outcome |
TimePoints |
To determine whether Dexmedetomidine or Ketamine intraoral spray is more effective in attenuating the post-operative sore throat in tonsillectomy. |
Comparing the time required for attenuation of sore throat in the two groups of participants at 0 hour, 2 hours, 6 hours 12 hours 18 hours and 24 hours post operatively. |
|
Secondary Outcome
|
Outcome |
TimePoints |
To evaluate any adverse effects of the drugs used i.e. Dexmedetomidine & Ketamine intraoral spray. |
To evaluate adverse effects of the drugs at 0 hour, 2 hours, 6 hours, 12 hours, 18 hours, 24 hours post operatively |
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
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)
|
07/04/2024 |
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="0" 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
|
Tracheal or nasal intubation for general anesthesia causes airway mucosa trauma resulting in postoperative sore throat (POST), hoarseness, and cough . POST is a minor and common problem in patients undergoing endotracheal intubation , which commonly occurs 12 to 24 hours after the operation. Despite the mildness of symptoms, POST is one of the major cause of post operative dissatisfaction after surgery . In most cases, POST heals after surgery without specific treatment. Moderate to severe POSTS with dysphagia and pain can be treated with pharmacological agents. Ketamine, a dissociative anesthetic agent, is the most potent of NMDA antagonists. Ketamine interacts noncompetitively with the NMDA receptors, suppresses the NMDA receptor mediated central sensitization, and potentially decreases postoperative pain Dexmedetomidine is an alpha2 adrenergic agonists which have sedative, hypnotic ,anxiolytic, analgesic, and sympatholytic effects. The analgesic effect of dexmedetomidine is mediated through stimulation of alpha 2c and alpha 2a receptors in the dorsal horn directly suppressing pain transmission by reducing the release of pronociceptive transmitters, substance P and glutamate and hyperpolarization of interneurons. Therefore, this study attempted primarily to shed light upon the efficacy of dexmedetomidine intraoral spray versus ketamine intraoral spray on reducing postoperative sore throat after tonsillectomy. |