StrabismusPhase 4NCT04549844
Peribulbar Block for Prevention of Oculocardiac Reflex
A Phase 4 study testing Bupivacaine in people with Strabismus, run by Fayoum University Hospital at 1 site in Egypt.
Trial summary
Strabismus is a common ophthalmic problem in Egypt that usually requires surgical correction. This surgery primarily aims to improve alignment of visual axis but may be required only for cosmetic reasons. Read more about this study
- Who is it for?
- Ages 10 to 50 years
- Conditions the study is for
- Strabismus
- What is being tested?
- Bupivacaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 14 Aug 2019to 14 Oct 2020
- 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 10 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients aged 10 years to 50 years
- American society association (ASA) physical status I, II
- Patient scheduled for a unilateral strabismus surgery.
Who cannot join
- Refusal of local anesthesia.
- Contraindications of local anesthesia e.g. allergy or hypersensitivity to local anesthetics or orbital inflammation .
- Pregnancy
- Glaucoma
- Communication barrier between physician and patient e.g. impaired hearing, impaired mental status
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Medicine -Fayoum University
Al Fayyum, 1234
mohamed hassan ragab, M.Sc, 1090050298 ext. +20, dr.mido.anesthesia@gmail.com
About this study
Official title: Comparative Study Between Combined General Anesthesia With Peribulbar Block Versus Traditional General Anesthesia in Patients Undergoing Strabismus Surgery
Strabismus is a common ophthalmic problem in Egypt that usually requires surgical correction. This surgery primarily aims to improve alignment of visual axis but may be required only for cosmetic reasons. General anesthesia is mandatory for most cases however a concomitant local anesthetics administration is preferable to improve patient satisfaction, decrease postoperative analgesic requirements and reduce post-operative pain. Oculocardiac reflex is a noted serious complication that accompanies such surgeries and may be life threatening. Oculocardiac reflex (OCR) is one of the main challenges that face anesthesiologists during strabismus surgery. The incidence of OCR varies from 16 to 82 % in strabismus surgeries and this wide range does depend on the anesthetic agents, premedications, and the definition of OCR being used. Maintenance of adequate depth of anesthesia and the use of anti-cholinergic is the mainstay to reduce this risk. OCR is usually defined as a decrease in heart rate of more than 20 % from the baseline. This reflex is triggered by the pressure on the extra ocular muscles (EOM) or eyeball, orbital hematoma or trauma, the afferent limb is from orbital contents to ciliary ganglion then to the sensory nucleus of the trigeminal nerve near the fourth ventricle through the ophthalmic division of the trigeminal nerve. The main response of this reflex is transmitted through the vagus to the heart. This vagal stimulation leads to a decrease in heart rate (sinus bradycardia), contractility and arrhythmias such as atrioventricular block, ventricular fibrillation up to cardiac arrest.
The incidence of the OCR decreases with age and tends to be more pronounced in young healthy patients. It has been suggested that the anesthetic agents used during surgery influence the incidence of OCR. To date, the only successful method to interrupt an OCR is to stop the EOM traction, and then proceed with caution as surgery continues. Depth of anesthesia is another presumed factor having an impact on reducing of OCR incidence.
The response to surgical stimulus can be minimized or stopped with the help of peribulbar block.
Read the detailed description
The study will be performed from July 2019 to February 2020 at Fayoum University hospital after approval of the local institutional ethics committee and local institutional review board. The study design will be prospective, randomized, parallel groups, controlled clinical trial. A detailed informed consent will be signed by the eligible participants before recruitment and randomization.
Randomization \& blinding:
It will be done by using computer-generated random numbers that will be placed in separate opaque envelopes that will be opened by study investigators just before the surgery. Neither the participants, the study investigators, the attending clinicians, nor the data collectors will be aware of groups' allocation till the study end. The Consolidated Standards of Reporting Trials (CONSORT) recommendations for reporting randomized, controlled clinical trials will be followed. This is the randomized case-control study. 30 patients will be randomly divided into 2 study groups .each group contains 15 patients; Group GA: Total 15 cases who will receive general anesthesia only, i.e., without peribulbar block.
Group GB: Total 15 cases who will receive general anesthesia with peribulbar block.
Anesthetic technique:
Preoperative preparations:
History taking, physical examination and investigation will be done according to local protocol designed to evaluate the patients which include complete blood count and coagulation profile. All cases will have a routine pre-operative check-up, starve for 6 h for solids and 2 hours for clear fluids and water. Written informed consent will be signed by adult patients or parents of pediatric participants.
Intraoperative technique and management:
Upon arrival to the operating room standard monitors (Pulse oximeter, Noninvasive blood pressure monitoring, and Electrocardiogram) will be applied and continued all over the operation and a peripheral intravenous (IV) cannula (20G) will be inserted.
After adequate pre-oxygenation, Induction will be accomplished with the injection of propofol 2 mg/kg and Fentanyl 1 µg/kg IV. Endotracheal intubation will be facilitated by the intravenous injection of 0.5 mg/kg atracurium. General anesthesia will be maintained by mechanical ventilation with oxygen and air (50:50), isoflurane.
Patients in peribulbar block group will receive lidocaine 2%, bupivacaine 0.5% and hyaluronidase with total volume 0.06 ml/kg keeping the ratio 1: 1 between lidocaine combined with hyaluronidase and bupivacaine by 24 Gauge needle after induction of general anesthesia and before start of surgery.
Intraoperative OCR with decrease of heart rate more than 20% from baseline. If happened it will be managed by asking the operator to stop the surgical traction and giving 0.01 mg/kg of atropine. If cardiac arrest was identified, resuscitation will be according to advanced cardiac life support (ACLS) protocols.
Perioperative Nausea and vomiting will be treated by ondansetron 0.15 mg/kg intravenously over 15 min.
Postoperative monitoring, Pain control and follow up:
At the end of surgery, Participant will be transferred to postoperative anesthesia care unit (PACU) with standard monitoring applied. Pain will be evaluated by visual analog score (VAS) score from (0_ 100) (where; zero = no pain, 100=worst imaginable pain) assessed at 2 ,4, 6 ,12 ,24 and after 24 h.
- Conditions
- Strabismus
- Being tested
- Bupivacaine
- Keywords
- Peribulbar block, Oculocardiac reflex
- Medical subject headings
- Strabismus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupivacaineDrug
Also called xylocaine hyaluronidase
After adequate pre-oxygenation, Induction will be accomplished with the injection of propofol 2 mg/kg and Fentanyl 1 µg/kg IV. Endotracheal intubation will be facilitated by the intravenous injection of 0.5 mg/kg atracurium. General anesthesia will be maintained by mechanical ventilation with oxygen and air (50:50), isoflurane.
Patients in peribulbar block group will receive lidocaine 2%, bupivacaine 0.5% and hyaluronidase with total volume 0.06 ml/kg keeping the ratio 1: 1 between lidocaine combined with hyaluronidase and bupivacaine by 24 Gauge needle after induction of general anesthesia and before start of surgery.
| Study group | Role | What they receive |
|---|---|---|
| the intervention group (G A) | Active comparator | Group general anaesthesia plus peribulbar block : Total 35 cases who will receive general anesthesia with peribulbar block (bupivacaine 0.5 % xylocaine 2% hyaluronidase with total volume 0.06 mg \kg (bupivacaine : (xylocaine :hyaluronidase ) 1:1) Patients in peribulbar block group will receive lidocaine 2%, bupivacaine 0.5% and hyaluronidase with total volume 0.06 ml/kg keeping the ratio 1: 1 between lidocaine combined with hyaluronidase and bupivacaine by 24 Gauge needle after induction of general anesthesia and before start of surgery. Receives: Drug: Bupivacaine |
| the control group (G B ) | Placebo comparator | General group: Total 35 cases who will receive general anesthesia only, i.e., without peribulbar block. (Fentanyl 1µg\kg, atracurium 0.5 mg\kg and propofol 2mg \kg.
After adequate pre-oxygenation, Induction will be accomplished with the injection of propofol 2 mg/kg and Fentanyl 1 µg/kg IV. Endotracheal intubation will be facilitated by the intravenous injection of 0.5 mg/kg atracurium. General anesthesia will be maintained by mechanical ventilation with oxygen and air (50:50), isoflurane. Receives: Drug: Bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of Oculocardiac reflex .
Occurence of bradycardia with heart rate decrease by 20% from baseline value or if dysrhythmias or sinus arrest after traction on extraocular muscles
Measured: 3 minutes after traction on extraocular muscles during squint surgery
Secondary outcomes (11)
Degree of post operative pain
Assessment by visual analog scale (VAS) score from 0 to 10 degree with 0 : no pain and 10: worst pain
Measured: 2 hours post operatively
Degree of post operative pain
Assessment by visual analog scale (VAS) score from 0 to 10 degree with 0 : no pain and 10: worst pain
Measured: 4 hours postoperatively
Degree of post operative pain
Assessment by visual analog scale (VAS) score from 0 to 10 degree with 0 : no pain and 10: worst pain
Measured: 6 hours postoperatively
Degree of post operative pain
Assessment by visual analog scale (VAS) score from 0 to 10 degree with 0 : no pain and 10: worst pain
Measured: 12 hours postoperatively
Degree of post operative pain
Assessment by visual analog scale (VAS) score from 0 to 10 degree with 0 : no pain and 10: worst pain
Measured: 24 hours postoperatively
Incidence of postoperative nausea and vomiting (PONV)
0: No nausea or vomiting
1: nausea or vomiting
Measured: 24 hours in the postoperative period
Patient satisfaction
According to satisfaction score from 0 to 3 (0:poor,1:fair, 2:good, 3:excellent)
Measured: 2 hours postoperatively
Patient satisfaction
According to satisfaction score from 0 to 3 (0:poor,1:fair, 2:good, 3:excellent)
Measured: 4 hours postoperatively
Patient satisfaction
According to satisfaction score from 0 to 3 (0:poor,1:fair, 2:good, 3:excellent)
Measured: 6 hours postoperatively
Patient satisfaction
According to satisfaction score from 0 to 3 (0:poor,1:fair, 2:good, 3:excellent)
Measured: 12 hours postoperatively
Patient satisfaction
According to satisfaction score from 0 to 3 (0:poor,1:fair, 2:good, 3:excellent)
Measured: 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2020
- Study start14 Aug 2019
- Primary completion14 Sep 2020 (estimated)
- Study completion14 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fayoum University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed yehia abdel latif, Fayoum University Hospital
- Investigators
- Maged Labib Boulos, MD, Principal investigator, faculty of medicine -fayoum universityKhalid Gamal Abu eleinen, MD, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04549844
- Sponsor's protocol ID
- M427
- Status last verified
- Sep 2020
- First submitted
- 4 Sep 2020
- Last updated
- 16 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Karanovic N, Carev M, Ujevic A, Kardum G, Dogas Z. Association of oculocardiac reflex and postoperative nausea and vomiting in strabismus surgery in children anesthetized with halothane and nitrous oxide. Paediatr Anaesth. 2006 Sep;16(9):948-54. doi: 10.1111/j.1460-9592.2006.01865.x.
PubMed 16918657Kosaka M, Asamura S, Kamiishi H. Oculocardiac reflex induced by zygomatic fracture; a case report. J Craniomaxillofac Surg. 2000 Apr;28(2):106-9. doi: 10.1054/jcms.2000.0107.
PubMed 10958423
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Combined General Anesthesia With Peribulbar Block Versus Traditional General Anesthesia in Patients Undergoing Strabismus Surgery
- ClinicalTrials.gov ID
- NCT04549844
- Acronym / sponsor ID
- M427
- Conditions
- Strabismus
- Keywords
- Peribulbar block, Oculocardiac reflex
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Fayoum University HospitalUniversity, hospital or other
- Study start
- 14 Aug 2019 (actual)
- Primary completion
- 14 Sep 2020 (estimated)
- Study completion
- 14 Oct 2020 (estimated)
- First posted
- 16 Sep 2020 (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.
Strabismus is a common ophthalmic problem in Egypt that usually requires surgical correction. This surgery primarily aims to improve alignment of visual axis but may be required only for cosmetic reasons. General anesthesia is mandatory for most cases however a concomitant local anesthetics administration is preferable to improve patient satisfaction, decrease postoperative analgesic requirements and reduce post-operative pain. Oculocardiac reflex is a noted serious complication that accompanies such surgeries and may be life threatening. Oculocardiac reflex (OCR) is one of the main challenges that face anesthesiologists during strabismus surgery. The incidence of OCR varies from 16 to 82 % in strabismus surgeries and this wide range does depend on the anesthetic agents, premedications, and the definition of OCR being used. Maintenance of adequate depth of anesthesia and the use of anti-cholinergic is the mainstay to reduce this risk. OCR is usually defined as a decrease in heart rate of more than 20 % from the baseline. This reflex is triggered by the pressure on the extra ocular muscles (EOM) or eyeball, orbital hematoma or trauma, the afferent limb is from orbital contents to ciliary ganglion then to the sensory nucleus of the trigeminal nerve near the fourth ventricle through the ophthalmic division of the trigeminal nerve. The main response of this reflex is transmitted through the vagus to the heart. This vagal stimulation leads to a decrease in heart rate (sinus bradycardia), contractility and arrhythmias such as atrioventricular block, ventricular fibrillation up to cardiac arrest.
The incidence of the OCR decreases with age and tends to be more pronounced in young healthy patients. It has been suggested that the anesthetic agents used during surgery influence the incidence of OCR. To date, the only successful method to interrupt an OCR is to stop the EOM traction, and then proceed with caution as surgery continues. Depth of anesthesia is another presumed factor having an impact on reducing of OCR incidence.
The response to surgical stimulus can be minimized or stopped with the help of peribulbar block.
Detailed description
The study will be performed from July 2019 to February 2020 at Fayoum University hospital after approval of the local institutional ethics committee and local institutional review board. The study design will be prospective, randomized, parallel groups, controlled clinical trial. A detailed informed consent will be signed by the eligible participants before recruitment and randomization.
Randomization \& blinding:
It will be done by using computer-generated random numbers that will be placed in separate opaque envelopes that will be opened by study investigators just before the surgery. Neither the participants, the study investigators, the attending clinicians, nor the data collectors will be aware of groups' allocation till the study end. The Consolidated Standards of Reporting Trials (CONSORT) recommendations for reporting randomized, controlled clinical trials will be followed. This is the randomized case-control study. 30 patients will be randomly divided into 2 study groups .each group contains 15 patients; Group GA: Total 15 cases who will receive general anesthesia only, i.e., without peribulbar block.
Group GB: Total 15 cases who will receive general anesthesia with peribulbar block.
Anesthetic technique:
Preoperative preparations:
History taking, physical examination and investigation will be done according to local protocol designed to evaluate the patients which include complete blood count and coagulation profile. All cases will have a routine pre-operative check-up, starve for 6 h for solids and 2 hours for clear fluids and water. Written informed consent will be signed by adult patients or parents of pediatric participants.
Intraoperative technique and management:
Upon arrival to the operating room standard monitors (Pulse oximeter, Noninvasive blood pressure monitoring, and Electrocardiogram) will be applied and continued all over the operation and a peripheral intravenous (IV) cannula (20G) will be inserted.
After adequate pre-oxygenation, Induction will be accomplished with the injection of propofol 2 mg/kg and Fentanyl 1 µg/kg IV. Endotracheal intubation will be facilitated by the intravenous injection of 0.5 mg/kg atracurium. General anesthesia will be maintained by mechanical ventilation with oxygen and air (50:50), isoflurane.
Patients in peribulbar block group will receive lidocaine 2%, bupivacaine 0.5% and hyaluronidase with total volume 0.06 ml/kg keeping the ratio 1: 1 between lidocaine combined with hyaluronidase and bupivacaine by 24 Gauge needle after induction of general anesthesia and before start of surgery.
Intraoperative OCR with decrease of heart rate more than 20% from baseline. If happened it will be managed by asking the operator to stop the surgical traction and giving 0.01 mg/kg of atropine. If cardiac arrest was identified, resuscitation will be according to advanced cardiac life support (ACLS) protocols.
Perioperative Nausea and vomiting will be treated by ondansetron 0.15 mg/kg intravenously over 15 min.
Postoperative monitoring, Pain control and follow up:
At the end of surgery, Participant will be transferred to postoperative anesthesia care unit (PACU) with standard monitoring applied. Pain will be evaluated by visual analog score (VAS) score from (0_ 100) (where; zero = no pain, 100=worst imaginable pain) assessed at 2 ,4, 6 ,12 ,24 and after 24 h.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the intervention group (G A) | Active comparator | Drug: BupivacaineGroup general anaesthesia plus peribulbar block : Total 35 cases who will receive general anesthesia with peribulbar block (bupivacaine 0.5 % xylocaine 2% hyaluronidase with total volume 0.06 mg \kg (bupivacaine : (xylocaine :hyaluronidase ) 1:1) Patients in peribulbar block group will receive lidocaine 2%, bupivacaine 0.5% and hyaluronidase with total volume 0.06 ml/kg keeping the ratio 1: 1 between lidocaine combined with hyaluronidase and bupivacaine by 24 Gauge needle after induction of general anesthesia and before start of surgery. |
| the control group (G B ) | Placebo comparator | Drug: BupivacaineGeneral group: Total 35 cases who will receive general anesthesia only, i.e., without peribulbar block. (Fentanyl 1µg\kg, atracurium 0.5 mg\kg and propofol 2mg \kg. After adequate pre-oxygenation, Induction will be accomplished with the injection of propofol 2 mg/kg and Fentanyl 1 µg/kg IV. Endotracheal intubation will be facilitated by the intravenous injection of 0.5 mg/kg atracurium. General anesthesia will be maintained by mechanical ventilation with oxygen and air (50:50), isoflurane. |
Who may qualify
- Ages
- 10 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Patients aged 10 years to 50 years
- American society association (ASA) physical status I, II
- Patient scheduled for a unilateral strabismus surgery.
Key exclusion criteria (5 listed)
- Refusal of local anesthesia.
- Contraindications of local anesthesia e.g. allergy or hypersensitivity to local anesthetics or orbital inflammation .
- Pregnancy
- Glaucoma
- Communication barrier between physician and patient e.g. impaired hearing, impaired mental status
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 |
|---|---|---|
| BupivacaineAlso: xylocaine hyaluronidaseAfter adequate pre-oxygenation, Induction will be accomplished with the injection of propofol 2 mg/kg and Fentanyl 1 µg/kg IV. Endotracheal intubation will be facilitated by the intravenous injection of 0.5 mg/kg atracurium. General anesthesia will be maintained by mechanical ventilation with oxygen and air (50:50), isoflurane. Patients in peribulbar block group will receive lidocaine 2%, bupivacaine 0.5% and hyaluronidase with total volume 0.06 ml/kg keeping the ratio 1: 1 between lidocaine combined with hyaluronidase and bupivacaine by 24 Gauge needle after induction of general anesthesia and before start of surgery. | Drug | the control group (G B ), the intervention group (G A) |
Primary outcome
The incidence of Oculocardiac reflex .
Time frame: 3 minutes after traction on extraocular muscles during squint surgery
Occurence of bradycardia with heart rate decrease by 20% from baseline value or if dysrhythmias or sinus arrest after traction on extraocular muscles
11 secondary outcomes
Degree of post operative pain
Time frame: 2 hours post operatively
Degree of post operative pain
Time frame: 4 hours postoperatively
Degree of post operative pain
Time frame: 6 hours postoperatively
Degree of post operative pain
Time frame: 12 hours postoperatively
Degree of post operative pain
Time frame: 24 hours postoperatively
Incidence of postoperative nausea and vomiting (PONV)
Time frame: 24 hours in the postoperative period
Patient satisfaction
Time frame: 2 hours postoperatively
Patient satisfaction
Time frame: 4 hours postoperatively
Patient satisfaction
Time frame: 6 hours postoperatively
Patient satisfaction
Time frame: 12 hours postoperatively
Patient satisfaction
Time frame: 24 hours postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2020.
- Background: PubMed 16918657Karanovic N, Carev M, Ujevic A, Kardum G, Dogas Z. Association of oculocardiac reflex and postoperative nausea and vomiting in strabismus surgery in children anesthetized with halothane and nitrous oxide. Paediatr Anaesth. 2006 Sep;16(9):948-54. doi: 10.1111/j.1460-9592.2006.01865.x.
- Background: PubMed 10958423Kosaka M, Asamura S, Kamiishi H. Oculocardiac reflex induced by zygomatic fracture; a case report. J Craniomaxillofac Surg. 2000 Apr;28(2):106-9. doi: 10.1054/jcms.2000.0107.
- Individual participant dataSharing planned: No
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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.
Maged Labib Boulos, MD principal investigator
faculty of medicine -fayoum university
Khalid Gamal Abu eleinen, MD principal investigator
Cairo University
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 Bupivacaine in people with Strabismus, run by Fayoum University Hospital at 1 site in Egypt.
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 16 Sep 2020. 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 Egypt. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact mahmoud Ramadan Ahmed, Bch (1000993093 ext. +20, mahram35@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of Oculocardiac reflex . (time frame: 3 minutes after traction on extraocular muscles during squint surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04549844, which also lists 2 linked publications.
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 16 Sep 2020.