Chronic Obstructive Pulmonary DiseaseSevoCOPDNCT06108973
Evaluation of Consumption of Sevoflurane in Chronic Obstructive Pulmonary Disease Patients
An observational study of Chronic Obstructive Pulmonary Disease, run by Employee's State Insurance Corporation, New Delhi.
Trial summary
All the Patients undergoing General Anesthesia and the patients who are having Chronic Obstructive Pulmonary Disease will be considered for this study. The Volume consumption of Sevoflurane will be studied in accordance with age, sex, duration , type of surgery, site of surgery and BMI.The volume consumption of… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Capnography
- Type of treatment
- Medical device
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2024to 30 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Geography South East Asia-Sothern Peninsular INDIA' Soci Economic Mid Earning
Who may be able to join
- Both Sex All Age Group Patient willing to give consent COPD patient
Who cannot join
- Not willing to give consent Cancerous Lung Lung Lobectomy
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Evaluation of Consumption of Sevoflurane in Chronic Obstructive Pulmonary Disease Patients Under General Anesthesia
All the Patients undergoing General Anesthesia and the patients who are having Chronic Obstructive Pulmonary Disease will be considered for this study. The Volume consumption of Sevoflurane will be studied in accordance with age, sex, duration , type of surgery, site of surgery and BMI.The volume consumption of sevoflurane is compared with Chronic Obstructive Pulmonary Disease and Normal Patients .
Read the detailed description
Chronic Obstructive pulmonary disease is known to escalate the consumption of Inhalation Agents in General Anesthesia. Hence the Data to Collect the Official Record
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Capnography
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CapnographyDevice
To know the Co2 graph in COPD and Normal patients under General Anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Normal Patients | Normal patients without any Lung Pathology for General Anesthesia Receives: Device: Capnography | |
| COPD patients | Established Chronic Obstructive Pulmonary Disease for General Anesthesia Receives: Device: Capnography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimation of Volume consumption of Sevoflurane
The consumption is expressed in Volume ml/kg
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2023
- Study start1 Jan 2024 (estimated)
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Employee's State Insurance Corporation, New Delhi
- Sponsor type
- Other government
- Collaborators
- Medtronic Spine LLC
- Responsible party
- Principal investigator, Santhosh Kumar T N, Employee's State Insurance Corporation, New Delhi
- Investigators
- Dr Manjunath, MD, Principal investigator, ESIC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06108973
- Sponsor's protocol ID
- 00127102023
- Acronym
- SevoCOPD
- Status last verified
- Oct 2023
- First submitted
- 26 Oct 2023
- Last updated
- 31 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Consumption of Sevoflurane in Chronic Obstructive Pulmonary Disease Patients Under General Anesthesia
- ClinicalTrials.gov ID
- NCT06108973
- Acronym / sponsor ID
- SevoCOPD / 00127102023
- Conditions
- Chronic Obstructive Pulmonary Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Employee's State Insurance Corporation, New DelhiOther government
- Collaborators
- Medtronic Spine LLC
- Study start
- 1 Jan 2024 (estimated)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Mar 2025 (estimated)
- First posted
- 31 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
All the Patients undergoing General Anesthesia and the patients who are having Chronic Obstructive Pulmonary Disease will be considered for this study. The Volume consumption of Sevoflurane will be studied in accordance with age, sex, duration , type of surgery, site of surgery and BMI.The volume consumption of sevoflurane is compared with Chronic Obstructive Pulmonary Disease and Normal Patients .
Detailed description
Chronic Obstructive pulmonary disease is known to escalate the consumption of Inhalation Agents in General Anesthesia. Hence the Data to Collect the Official Record
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal Patients | – | Device: CapnographyNormal patients without any Lung Pathology for General Anesthesia |
| COPD patients | – | Device: CapnographyEstablished Chronic Obstructive Pulmonary Disease for General Anesthesia |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Geography South East Asia-Sothern Peninsular INDIA' Soci Economic Mid Earning
Key inclusion criteria (1 listed)
- Both Sex All Age Group Patient willing to give consent COPD patient
Key exclusion criteria (1 listed)
- Not willing to give consent Cancerous Lung Lung Lobectomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CapnographyTo know the Co2 graph in COPD and Normal patients under General Anesthesia | Device | COPD patients, Normal Patients |
Primary outcome
Estimation of Volume consumption of Sevoflurane
Time frame: 8 weeks
The consumption is expressed in Volume ml/kg
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2023.
- Individual participant dataSharing planned: No
Related trials for Chronic Obstructive Pulmonary Disease
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease
Chronic Graft Versus Host Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr Manjunath, MD principal investigator
ESIC
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease, run by Employee's State Insurance Corporation, New Delhi.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Santhosh Kumar T N, BSc (6366470104, tumakuru572102@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Estimation of Volume consumption of Sevoflurane (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2023.