Anesthesia and AnalgesiaPhase 2/3NCT06382831
Opioid Free Versus Opioid Balanced Anesthesia in Ophthalmic Surgery
A Phase 2/3 study testing Dexmedetomidine and Fentanyl in people with Anesthesia and Analgesia and Anesthesia, Endotracheal, run by Universitas Indonesia.
Trial summary
Anesthesia without the use of opioid (Opioid free anesthesia) is an alternative to conventional opioid balanced anesthesia, with less post operative nausea and vomiting, and comparable analgesia. This study aim to compare the effect of opioid free versus opioid balanced anesthesia in ophthalmology surgery Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Anesthesia and Analgesia, Anesthesia, Endotracheal
- What is being tested?
- Dexmedetomidine and Fentanyl
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2024to 1 Oct 2024
- Phase
- Phase 2/3
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Physical status of ASA 1-2
- Undergo elective ophthalmology surgery under general anesthesia with laryngeal mask insertion
- BMI 17.5-34.9
Who cannot join
- Allergy to study drugs
- Baseline heart rate < 70 beat per minute or systolic blood pressure < 100 mmHg
- Will undergo regional block
- Operation lasting for > 4 hours or < 90 minutes
- Consumes opioid routinely prior to operation
About this study
Official title: Comparing Opioid Free Versus Opioid Balanced Anesthesia in Ophthalmic Surgery: a Single Centre Randomized Controlled Trial
Anesthesia without the use of opioid (Opioid free anesthesia) is an alternative to conventional opioid balanced anesthesia, with less post operative nausea and vomiting, and comparable analgesia. This study aim to compare the effect of opioid free versus opioid balanced anesthesia in ophthalmology surgery
- Conditions
- Anesthesia and Analgesia, Anesthesia, Endotracheal
- Being tested
- Dexmedetomidine, Fentanyl
- Keywords
- Opioid free anesthesia, Ocular surgery, Ophthalmology surgery, Dexmedetomidine, Post operative nausea and vomiting
- Medical subject headings
- Agnosia, Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Opioid free anesthesia
FentanylDrug
Control given Opioid balanced anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Not described Receives: Drug: Fentanyl |
| Opioid free anesthesia | Experimental | Not described Receives: Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative nausea and vomiting (PONV)
Incidence of PONV
Measured: 24 hours
Pain score
Pain score assessed with numerical rating scale (0-10) where higher value corresponds to more pain experienced by the patient
Measured: 24 hours
Time to laryngeal mask exertion
Measured from the last surgical knot to LMA exertion
Measured: Intraoperative
Adverse effect
Severe changes in hemodynamics, including severe bradycardia, tachycardia, hypotension, hypertension, desaturation
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2024
- Study start1 Jun 2024 (estimated)
- Primary completion1 Aug 2024 (estimated)
- Study completion1 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia and AnalgesiaStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aida Rosita Tantri, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06382831
- Sponsor's protocol ID
- IndonesiaU240201
- Status last verified
- Apr 2024
- First submitted
- 19 Apr 2024
- Last updated
- 30 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Participants' data is kept under strict regulation by the study investigator and will not be shared without participants' consent
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Opioid Free Versus Opioid Balanced Anesthesia in Ophthalmic Surgery: a Single Centre Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06382831
- Acronym / sponsor ID
- IndonesiaU240201
- Conditions
- Anesthesia and Analgesia, Anesthesia, Endotracheal
- Keywords
- Opioid free anesthesia, Ocular surgery, Ophthalmology surgery, Dexmedetomidine, Post operative nausea and vomiting
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 1 Jun 2024 (estimated)
- Primary completion
- 1 Aug 2024 (estimated)
- Study completion
- 1 Oct 2024 (estimated)
- First posted
- 24 Apr 2024 (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.
Anesthesia without the use of opioid (Opioid free anesthesia) is an alternative to conventional opioid balanced anesthesia, with less post operative nausea and vomiting, and comparable analgesia. This study aim to compare the effect of opioid free versus opioid balanced anesthesia in ophthalmology surgery
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Drug: Fentanyl |
| Opioid free anesthesia | Experimental | Drug: Dexmedetomidine |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Physical status of ASA 1-2
- Undergo elective ophthalmology surgery under general anesthesia with laryngeal mask insertion
- BMI 17.5-34.9
Key exclusion criteria (5 listed)
- Allergy to study drugs
- Baseline heart rate < 70 beat per minute or systolic blood pressure < 100 mmHg
- Will undergo regional block
- Operation lasting for > 4 hours or < 90 minutes
- Consumes opioid routinely prior to operation
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 |
|---|---|---|
| DexmedetomidineOpioid free anesthesia | Drug | Opioid free anesthesia |
| FentanylControl given Opioid balanced anesthesia | Drug | Control |
Primary outcome
Postoperative nausea and vomiting (PONV)
Time frame: 24 hours
Incidence of PONV
Pain score
Time frame: 24 hours
Pain score assessed with numerical rating scale (0-10) where higher value corresponds to more pain experienced by the patient
Time to laryngeal mask exertion
Time frame: Intraoperative
Measured from the last surgical knot to LMA exertion
Adverse effect
Time frame: 24 hours
Severe changes in hemodynamics, including severe bradycardia, tachycardia, hypotension, hypertension, desaturation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2024.
- Individual participant dataSharing planned: No. Participants' data is kept under strict regulation by the study investigator and will not be shared without participants' consent
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Pain Management
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.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Dexmedetomidine and Fentanyl in people with Anesthesia and Analgesia and Anesthesia, Endotracheal, run by Universitas Indonesia.
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 3 inclusion and 5 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 30 Apr 2024. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
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?
Postoperative nausea and vomiting (PONV) (time frame: 24 hours). The study lists 4 primary outcomes in all. 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 30 Apr 2024.