| CTRI Number |
CTRI/2025/08/092743 [Registered on: 11/08/2025] Trial Registered Prospectively |
| Last Modified On: |
08/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to compare the effect of nasal spray forms of ketamine and dexmedetomidine in reducing pain after nose surgery (septoplasty) in adult patients |
|
Scientific Title of Study
|
Comparison of Intranasal Dexmedetomidine and Intranasal Ketamine as preemptive analgesics in patients undergoing septoplasty: A prospective randomized trial |
| 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 Abin Thomas |
| Designation |
Doctor, Junior resident |
| Affiliation |
AIIMS Mangalagiri |
| Address |
Department of Anesthesiology, AIIMS MANGALAGIRI, Mangalagiri, Guntur , Andhra Pradesh
AIIMS MANGALAGIRI, Mangalagiri, Guntur , Andhra Pradesh
Guntur
ANDHRA PRADESH
522503
India |
| Phone |
7907026432 |
| Fax |
|
| Email |
m02jan025001@aiimsmangalagiri.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sunit Kumar Gupta |
| Designation |
Associate professor |
| Affiliation |
Department of Anesthesiology,AIIMS Mangalagiri |
| Address |
Room no 1052, Department of Anesthesiology,AIIMS MANGALAGIRI, Mangalagiri, Guntur , Andhra Pradesh
AIIMS MANGALAGIRI, Mangalagiri, Guntur , Andhra Pradesh
Guntur
ANDHRA PRADESH
522503
India |
| Phone |
9878984295 |
| Fax |
|
| Email |
drsunit.anesth@aiimsmangaklagiri.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Abin Thomas |
| Designation |
Doctor, Junior resident |
| Affiliation |
AIIMS Mangalagiri |
| Address |
Room no 1052,Department of Anesthesiology, AIIMS MANGALAGIRI, Mangalagiri, Guntur , Andhra Pradesh
AIIMS MANGALAGIRI, Mangalagiri, Guntur , Andhra Pradesh
Guntur
ANDHRA PRADESH
522503
India |
| Phone |
7907026432 |
| Fax |
|
| Email |
m02jan025001@aiimsmangalagiri.edu.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Abin Thomas |
| Address |
Junior Resident (Academic),
Department of Anesthesiology,
All India Institute of Medical Sciences (AIIMS),
Mangalagiri, Guntur District,
Andhra Pradesh – 522503, India
|
| Type of Sponsor |
Other [Individual ] |
|
|
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 Abin Thomas |
AIIMS Mangalagiri |
Room no 1052, Department of Anesthesiology,AIIMS Mangalagiri, Mangalagiri, Guntur, Andhra Pradesh,522503
Guntur
ANDHRA PRADESH |
7907026432
m02jan025001@aiimsmangalagiri.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute ethics committee Aiims Mangalagiri |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J342||Deviated nasal septum, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Intranasal Dexmedetomidine
|
Intranasal dexmedetomidine 2 mcg/kg administered using an insulin syringe 45–60 minutes prior to induction. The drug is instilled in 0.3 ml increments, half in each nostril, with a total volume not exceeding 2 ml. |
| Comparator Agent |
Intranasal Ketamine
|
Intranasal ketamine 0.5 mg/kg administered using an insulin syringe 45–60 minutes prior to induction. The drug is instilled in 0.3 ml increments, half in each nostril, with a total volume not exceeding 2 ml.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged 18 to 60 years, ASA physical status I or II, undergoing elective septoplasty under general anaesthesia at AIIMS Mangalagiri, willing to provide written informed consent. |
|
| ExclusionCriteria |
| Details |
Patients aged less than 18 or more than 60 years of age, known allergy to study drugs, pregnant or lactating women, BMI more than 30 kg perm², septoplasty lasting more than 120 minutes, refusal to participate. |
|
|
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 |
| Numeric Rating Scale (NRS) pain score at the 4th postoperative hour |
primary outcome — NRS pain score — will be assessed at the 4th postoperative hour. So, the time point for the primary outcome is the 4th hour after surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Sedation score using Ramsay Sedation Scale |
Preoperatively and at 1, 4, 12, and 24 hours postoperatively
|
| Intraoperative and postoperative hemodynamic parameters (heart rate, blood pressure, MAP, SpO2) |
Intraoperatively every 15 minutes and postoperatively at 1, 4, 12, and 24 hours |
Requirement of additional intraoperative analgesics
|
Throughout intraoperative period
|
Requirement of rescue analgesics in postoperative period
|
Within 24 hours postoperatively |
| Incidence of drug-related adverse effects |
From drug administration until 24 hours postoperatively
|
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
01/10/2025 |
| 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="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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [m02jan025001@aiimsmangalagiri.edu.in].
- For how long will this data be available start date provided 01-09-2025 and end date provided 31-08-2032?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This is a prospective, randomized, double-blind clinical trial conducted at AIIMS Mangalagiri to compare the perioperative analgesic effectiveness of intranasal dexmedetomidine and intranasal ketamine as pre-emptive analgesics in adult patients undergoing septoplasty. A total of 60 patients will be enrolled and randomized into two equal groups. One group will receive intranasal dexmedetomidine 2 mcg per kg, and the other will receive intranasal ketamine 0.5 mg per kg, administered 45 to 60 minutes prior to induction of general anesthesia. The primary outcome is pain score at the fourth postoperative hour using the Numeric Rating Scale. Secondary outcomes include sedation scores, hemodynamic stability, requirement for additional analgesics, and incidence of adverse effects. The study aims to identify the more effective non-invasive pre-emptive analgesic agent for use in septoplasty.
|