StrabismusPhase 4NCT02379546
The Effect of Anaesthesia Depth on Oculo-cardiac Reflex
A Phase 4 study testing Desflurane and Bispectral index monitoring in people with Strabismus and Anesthesia, General, run by Tokat Gaziosmanpasa University at 1 site in Turkey (Türkiye).
Trial summary
This study was designed to determine the effect of the depth of anesthesia on the oculocardiac reflex (OCR) during pediatric strabismus surgery. Read more about this study
- Who is it for?
- Ages 3 to 16 years
- Conditions the study is for
- Strabismus, Anesthesia, General
- What is being tested?
- Desflurane and Bispectral index monitoring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Aug 2013to May 2015
- 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 3 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- physical status ASA (American Society of Anesthesiologists) I
- scheduled for elective strabismus surgery under general anesthesia
- aged between 3-16 years
Who cannot join
- have a neurological or cardiovascular disease
- receiving antiepileptic or another medications known to affect EEG or ECG
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Anaesthesia Depth on Oculo-cardiac Reflex in Strabismus Surgery
This study was designed to determine the effect of the depth of anesthesia on the oculocardiac reflex (OCR) during pediatric strabismus surgery.
Read the detailed description
The oculo-cardiac reflex (OCR) is a trigeminovagal reflex which is started by the stimulus on the extra-ocular muscle and may lead to serious bradycardia or arrhythmia in the patients during strabismus surgery. It is presumed that the depth of anesthesia is one of the influencing factor on the OCR. But the clinical trials which are evaluating the relationship between the anesthesia depth and OCR are scarce. The main objective of this study is to determine the impact of the depth of anaesthesia that is adjusted with the bispectral index (BIS) monitor on the incidence of OCR in pediatric patients undergoing strabismus surgery.
- Conditions
- Strabismus, Anesthesia, General
- Being tested
- Desflurane, Bispectral index monitoring
- Keywords
- reflex, oculocardiac, monitoring, intraoperative
- Medical subject headings
- Strabismus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DesfluraneDrug
Desflurane will be used to maintain the anesthesia and the dose of desflurane will be adjusted according to the Bispectral İndex Monitoring
Bispectral index monitoringDevice
Also called BIS
Bispectral index monitoring (BIS XP, A-2000, VERSİON 3.31, Aspect Medical Systems, Newton, Mass, USA)will be used to determine the depth of anesthesia
| Study group | Role | What they receive |
|---|---|---|
| BIS<50 | Experimental | Anaesthesia will be maintained with desflurane in a 50% O2-Air mixture by titrating the concentration according to the Bispectral index monitoring to keep the Bispectral index values below 50. Receives: Drug: Desflurane; Device: Bispectral index monitoring |
| BIS≥50 | Active comparator | Anaesthesia will be maintained with desflurane in a 50% O2-Air mixture by titrating the concentration according to the Bispectral index monitoring to keep the Bispectral index values above 50. Receives: Drug: Desflurane; Device: Bispectral index monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect of the anaesthesia depth on the incidence of oculocardiac reflex
Measured: during the traction of the extra-ocular muscle in the strabismus surgery
Secondary outcomes (1)
The incidence of the oculocardiac reflex depending the type of operated extra-ocular muscle during the strabismus surgery
Measured: during the traction of the extra-ocular muscle in the strabismus surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2015 (estimated)
- Study startAug 2013
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrabismusStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tokat Gaziosmanpasa University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tuğba Karaman, Tokat Gaziosmanpasa University
- Investigators
- Tuğba Karaman, Principal investigator, GOU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02379546
- Sponsor's protocol ID
- GaziosmanpashaU-2
- Status last verified
- May 2015
- First submitted
- 17 Feb 2015
- Last updated
- 28 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Anaesthesia Depth on Oculo-cardiac Reflex in Strabismus Surgery
- ClinicalTrials.gov ID
- NCT02379546
- Acronym / sponsor ID
- GaziosmanpashaU-2
- Conditions
- Strabismus, Anesthesia, General
- Keywords
- reflex, oculocardiac, monitoring, intraoperative
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Tokat Gaziosmanpasa UniversityUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 5 Mar 2015 (estimated)
- 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.
This study was designed to determine the effect of the depth of anesthesia on the oculocardiac reflex (OCR) during pediatric strabismus surgery.
Detailed description
The oculo-cardiac reflex (OCR) is a trigeminovagal reflex which is started by the stimulus on the extra-ocular muscle and may lead to serious bradycardia or arrhythmia in the patients during strabismus surgery. It is presumed that the depth of anesthesia is one of the influencing factor on the OCR. But the clinical trials which are evaluating the relationship between the anesthesia depth and OCR are scarce. The main objective of this study is to determine the impact of the depth of anaesthesia that is adjusted with the bispectral index (BIS) monitor on the incidence of OCR in pediatric patients undergoing strabismus surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BIS<50 | Experimental | Drug: Desflurane, Device: Bispectral index monitoringAnaesthesia will be maintained with desflurane in a 50% O2-Air mixture by titrating the concentration according to the Bispectral index monitoring to keep the Bispectral index values below 50. |
| BIS≥50 | Active comparator | Drug: Desflurane, Device: Bispectral index monitoringAnaesthesia will be maintained with desflurane in a 50% O2-Air mixture by titrating the concentration according to the Bispectral index monitoring to keep the Bispectral index values above 50. |
Who may qualify
- Ages
- 3 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- physical status ASA (American Society of Anesthesiologists) I
- scheduled for elective strabismus surgery under general anesthesia
- aged between 3-16 years
Key exclusion criteria (2 listed)
- have a neurological or cardiovascular disease
- receiving antiepileptic or another medications known to affect EEG or ECG
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 |
|---|---|---|
| DesfluraneDesflurane will be used to maintain the anesthesia and the dose of desflurane will be adjusted according to the Bispectral İndex Monitoring | Drug | BIS<50, BIS≥50 |
| Bispectral index monitoringAlso: BISBispectral index monitoring (BIS XP, A-2000, VERSİON 3.31, Aspect Medical Systems, Newton, Mass, USA)will be used to determine the depth of anesthesia | Device | BIS<50, BIS≥50 |
Primary outcome
The effect of the anaesthesia depth on the incidence of oculocardiac reflex
Time frame: during the traction of the extra-ocular muscle in the strabismus surgery
1 secondary outcome
The incidence of the oculocardiac reflex depending the type of operated extra-ocular muscle during the strabismus surgery
Time frame: during the traction of the extra-ocular muscle in the strabismus surgery
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 28 May 2015.
Related trials for Strabismus
Not yet recruiting
Comparative Study Of Combined Recession-Resection And Fenestration of Superior Rectus Muscle for Treatment of Dissociated Vertical Deviation
Dissociated Vertical Deviation
RecruitingObservational study
Intraoperative OCT Guidance of Intraocular Surgery II
Macular Holes, Epiretinal Membrane
Not yet recruitingPhase 4
Effect of Ketamine-Propofol Total Intravenous Anesthesia Versus Sevoflurane-Based Anesthesia on Postoperative Vomiting in Children Undergoing Strabismus Surgery
Postoperative Vomiting, Postoperative Nausea and Vomiting
RecruitingObservational study
Eye-Hand Cross-Dominance and Upper Extremity Performance in Volleyball Players
Volleyball Player
Recruiting
Vision Therapy Versus Prism Treatment in Small-angle Acute Acquired Concomitant Esotropia
Esotropia
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.
Tuğba Karaman principal investigator
GOU
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 Bispectral index monitoring in people with Strabismus and Anesthesia, General, run by Tokat Gaziosmanpasa University at 1 site in Turkey (Türkiye).
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 2 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 28 May 2015. 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 Turkey (Türkiye). 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?
The effect of the anaesthesia depth on the incidence of oculocardiac reflex (time frame: during the traction of the extra-ocular muscle in the strabismus surgery). 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 28 May 2015.