Propofol Target-controlled InfusionPhase 4ONSDNCT07359508
Effect of Desflurane v/s Propofol on the Optic Nerve Sheath Diameter
A Phase 4 study testing Desflurane and Propofol (Group P) in people with Propofol Target-controlled Infusion and Desflurane, run by All India Institute of Medical Sciences at 1 site in India.
Trial summary
effect of propofol vs desflurane on ONSD Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Propofol Target-controlled Infusion, Desflurane, Optic Nerve Sheath Diameter
- What is being tested?
- Desflurane and Propofol (Group P)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 1 siteIndia
- Study dates
- 10 Jan 2024to 15 Jul 2025
- Phase
- Phase 4
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patient aged 18-60 years ASA grade I or II scheduled for elective laparoscopic cholecystectomy
Who cannot join
- patients with ophthalmological and cerebrovascular diseases, systemic infections, psychiatric disorders, pregnancy, Intracranial space occupying lesion, abnormal liver/kidney functions prior myocardial infarction.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Desflurane v/s Propofol on the Optic Nerve Sheath Diameter in Patients Undergoing Laparoscopic Cholecystectomy
effect of propofol vs desflurane on ONSD
- Being tested
- Desflurane, Propofol (Group P)
- Keywords
- propofol, ONSD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DesfluraneDrug
In the D group, anesthesia was maintained with oxygen/air (40:60), desflurane, fentanyl and vecuronium
Propofol (Group P)Drug
In the P group, anesthesia was maintained with oxygen/air (40:60), propofol infusion @50 to 100mcg/kg/min, fentanyl and Vecuronium
| Study group | Role | What they receive |
|---|---|---|
| Propofol group | Experimental | propofol infusion will be given in this group after induction of the patient Receives: Drug: Propofol (Group P) |
| Desflurane | Experimental | desflurane inhalation will be given in this group, after induction Receives: Drug: Desflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Optic nerve sheath diameter(ONSD)
ONSD will be measured in the operation thetaer
Measured: before induction, introperative period for every 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2026
- Study start10 Jan 2024
- Primary completion15 Jun 2025
- Study completion15 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Propofol Target-controlled InfusionStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- All India Institute of Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- All India Institute of Medical Science, Raebareli
- Responsible party
- Principal investigator, ADABALA VIJAY BABU, All India Institute of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07359508
- Sponsor's protocol ID
- 2
- Other IDs
- AllMS
- Acronym
- ONSD
- Status last verified
- Jan 2026
- First submitted
- 14 Jan 2026
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Desflurane v/s Propofol on the Optic Nerve Sheath Diameter in Patients Undergoing Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT07359508
- Acronym / sponsor ID
- ONSD / 2
- Keywords
- propofol, ONSD
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- All India Institute of Medical SciencesUniversity, hospital or other
- Collaborators
- All India Institute of Medical Science, Raebareli
- Study start
- 10 Jan 2024 (actual)
- Primary completion
- 15 Jun 2025 (actual)
- Study completion
- 15 Jul 2025 (actual)
- First posted
- 22 Jan 2026 (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.
effect of propofol vs desflurane on ONSD
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Propofol group | Experimental | Drug: Propofol (Group P)propofol infusion will be given in this group after induction of the patient |
| Desflurane | Experimental | Drug: Desfluranedesflurane inhalation will be given in this group, after induction |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patient aged 18-60 years ASA grade I or II scheduled for elective laparoscopic cholecystectomy
Key exclusion criteria (1 listed)
- patients with ophthalmological and cerebrovascular diseases, systemic infections, psychiatric disorders, pregnancy, Intracranial space occupying lesion, abnormal liver/kidney functions prior myocardial infarction.
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 |
|---|---|---|
| DesfluraneIn the D group, anesthesia was maintained with oxygen/air (40:60), desflurane, fentanyl and vecuronium | Drug | Desflurane |
| Propofol (Group P)In the P group, anesthesia was maintained with oxygen/air (40:60), propofol infusion @50 to 100mcg/kg/min, fentanyl and Vecuronium | Drug | Propofol group |
Primary outcome
Optic nerve sheath diameter(ONSD)
Time frame: before induction, introperative period for every 10 minutes
ONSD will be measured in the operation thetaer
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Desflurane and Propofol (Group P) in people with Propofol Target-controlled Infusion and Desflurane, run by All India Institute of Medical Sciences at 1 site in India.
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: finished, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Optic nerve sheath diameter(ONSD) (time frame: before induction, introperative period for every 10 minutes). 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 22 Jan 2026.