Administering inhaled ketamine in patients with increased severity of COPD.

Effect of nebulised ketamine in management of acute exacerbation of COPD: A pilot randomised controlled trial. - NIL

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/09/094787

Enrollment

Registered

2025-09-15

Start date

Unknown

Completion date

Unknown

Last updated

2025-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: J00-J99- Diseases of the respiratory system

Interventions

Intervention1: 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 wi

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
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.Timepoint: 0 to 120 min where 0 being the time of administration of nebulised ketamine.	—

Secondary

Measure	Time frame
To assess the changes in oxygen saturation, respiratory rate and arterial blood gas parameters with in 120 mins.Timepoint: 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.Timepoint: 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.Timepoint: 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.Timepoint: 0 to 120 min where 0 being the time of administration of nebulised ketamine.	—

Measure

Time frame

To assess the changes in oxygen saturation, respiratory rate and arterial blood gas parameters with in 120 mins.Timepoint: 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.Timepoint: 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.Timepoint: 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.Timepoint: 0 to 120 min where 0 being the time of administration of nebulised ketamine.

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Countries

India

Contacts

Public ContactPrakash Ranjan Mishra

AIIMS New Delhi

ranjan.prakashmishra@gmail.com8826118924

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026