| CTRI Number |
CTRI/2025/09/094787 [Registered on: 15/09/2025] Trial Registered Prospectively |
| Last Modified On: |
13/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Administering inhaled ketamine in patients with increased severity of COPD. |
|
Scientific Title of Study
|
Effect of nebulised ketamine in management of acute exacerbation of COPD: A pilot randomised controlled 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 |
Akhilesh Singh Chandel |
| Designation |
Junior Resident |
| Affiliation |
AIIMS New Delhi |
| Address |
Department of Emergency Medicine AIIMS, Ansari Nagar, New Delhi
South
DELHI
110029
India |
| Phone |
8894005218 |
| Fax |
|
| Email |
akhileshsinghchandel@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prakash Ranjan Mishra |
| Designation |
Associate Professor |
| Affiliation |
AIIMS New Delhi |
| Address |
Department of Emergency Medicine AIIMS, Ansari Nagar, New Delhi
South
DELHI
110029
India |
| Phone |
8826118924 |
| Fax |
|
| Email |
ranjan.prakashmishra@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prakash Ranjan Mishra |
| Designation |
Associate Professor |
| Affiliation |
AIIMS New Delhi |
| Address |
Department of Emergency Medicine AIIMS, Ansari Nagar, New Delhi
South
DELHI
110029
India |
| Phone |
8826118924 |
| Fax |
|
| Email |
ranjan.prakashmishra@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institue of Medical Sciences, New Delhi, 110029, India |
|
|
Primary Sponsor
|
| Name |
Department of Emergency Medicine, AIIMS New Delhi |
| Address |
AIIMS New Delhi, Ansari Nagar, New Delhi 110029 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Akhilesh Singh Chandel |
All India Institue of Medical Sciences, New Delhi |
EM-1, Department of Emergency Medicine AIIMS, Ansari Nagar, New Delhi, 110029
South
DELHI |
08894005218
akhileshsinghchandel@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee for Post Graduate Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J00-J99||Diseases of the respiratory system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nebulised Ketamine plus standard care. |
Ketamine 0.5 mg/kg (max 50 mg) diluted in 10 mL normal saline nebulised using a jet nebuliser or with 1-4 l/min oxygen over 5-10 minutes along with standard care to a known case of COPD patient with acute exacerbation. |
| Comparator Agent |
Placebo plus standard care. |
10 ml normal saline nebulised using a jet nebuliser or with 1-4 l/min oxygen over 5-10 minutes along with standard care to a known case of COPD patient with acute exacerbation. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients with known diagnosis of COPD based on GOLD criteria
Presentation with acute exacerbation (increased dyspnoea, sputum volume, or purulence)
Ability to provide written informed consent
|
|
| ExclusionCriteria |
| Details |
Hemodynamic instability (SBP less than 90 mmHg or MAP less than 65 mmHg)
Immediate need for endotracheal intubation
Glasgow Coma Scale less than 15
Active psychosis or significant psychiatric illness
Known allergy or hypersensitivity to ketamine
Pregnancy or lactation
Chronic kidney disease (stage 4 or 5)
Decompensated liver disease
Recent myocardial infarction (less than 4 weeks)
Tracheostomy or patients already intubated |
|
|
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 evaluate the effect of nebulised ketamine, in addition to standard care, in improving respiratory function in patients with acute exacerbation of chronic obstructive pulmonary disease as measured by the change in peak expiratory flow rate at 0, 15, 30, 60 and 120 min of administration. |
0 to 120 min where 0 being the time of administration of nebulised ketamine. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the changes in oxygen saturation, respiratory rate and arterial blood gas parameters with in 120 mins. |
0 to 120 min where 0 being the time of administration of nebulised ketamine. |
| To evaluate the time to clinical improvement as judged by visual analogue score with in 120 mins. |
0 to 120 min where 0 being the time of administration of nebulised ketamine. |
| To determine the need for escalation of respiratory support to mechanical ventilation. |
0 to 120 min where 0 being the time of administration of nebulised ketamine. |
| To monitor for adverse effects like hallucinations, nausea etc. within 120 min. |
0 to 120 min where 0 being the time of administration of nebulised ketamine. |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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 2 |
|
Date of First Enrollment (India)
|
25/09/2025 |
| 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="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
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
|
This is a single-blind, randomized controlled Phase II trial designed to evaluate the efficacy and safety of nebulized ketamine as an adjunct to standard therapy in patients presenting with severe acute exacerbation of chronic obstructive pulmonary disease (AECOPD). Eligible patients presenting to the emergency department with severe AECOPD will be randomly assigned to receive either nebulized ketamine (0.5 mg/kg, max 50 mg in 10 mL NS) or nebulized saline (10 mL NS) every 20 minutes for up to three doses, in addition to standard COPD therapy. The primary outcome is the change in Peak Expiratory Flow Rate (PEFR) from baseline to 60 minutes. Secondary outcomes include dyspnea score (VAS), oxygen saturation, need for non-invasive ventilation or intubation, arterial blood gas and adverse effects within the first 2 hours. The sample size was calculated based on previous randomized trials using ketamine in airway diseases, targeting a total of 70 patients (including 10% attrition). |