StrabismusNCT04821817
Peribulbar Rocuronium in Adult Strabismus Surgery
A study testing Normal saline and Rocuronium in people with Strabismus and Regional Anesthesia Morbidity, run by Tanta University at 1 site in Egypt.
Trial summary
This is a prospective randomized clinical study that will be carried on adult patients aged from 21-60 years and presented for strabismus surgery under peribulbar anesthesia. Patients will be excluded if they refused to participate or had a contraindication to peribulbar anesthesia. Read more about this study
- Who is it for?
- Ages 21 to 60 years
- Conditions the study is for
- Strabismus, Regional Anesthesia Morbidity, Rocuronium
- What is being tested?
- Normal saline and Rocuronium
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Apr 2021to 9 Feb 2025
- Phase
- Interventional
- 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 21 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adult patients
- Aged 21- 60 years
- American Society of Anesthesiologists class (ASA) I to III
- presented for elective strabismus surgery under peribulbar anesthesia.
Who cannot join
- Patient refusal to participate.
- uncooperative patient.
- Neurological disorders.
- Psychological disorders
- Suspected or diagnosed coagulopathy.
- Known allergy to the used medications.
- Ocular infection
- Co-existing glaucoma
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Rocuronium as an Anesthetic Adjuvant in Peribulbar Anesthesia for Adult Strabismus Surgery: Randomized Controlled Double-blind Study
- This is a prospective randomized clinical study that will be carried on adult patients aged from 21-60 years and presented for strabismus surgery under peribulbar anesthesia.
- Patients will be excluded if they refused to participate or had a contraindication to peribulbar anesthesia.
- Patients will be randomly distributed into either control group in which peribulbar anesthesia will be performed by injection of 10 ml local anesthetic mixture composed of 4 ml of plain bupivacaine 0.5%, 4 ml of lidocaine 2% containing 50 IU, and 2 ml normal saline or rocuronium group which peribulbar anesthesia will be performed by injection of 10 ml local anesthetic mixture composed of 4 ml of plain bupivacaine 0.5%, 4 ml of lidocaine 2% containing 50 IU, and 0.06 mg/kg of rocuronium in 2 ml normal saline.
- Measurements will include; -
- Patient age, weight, height, gestational age, and gravidity.
- The duration of globe akinesia (primary outcome).
- The onset of lid and globe akinesia and the duration of lid akinesia
- The onset and duration of sensory block
- Time required to start the surgery
- Akinesia score
- The visual analog score (VAS) which is composed of 0-10 score will be used to assess the severity of postoperative pain (where 0=no pain and 10=severe pain), The VAS score will be evaluated 1 h, 2 h postoperative, then every 2 h till 12 h. Any patients with VAS score more than 4 received rescue analgesia in the form of 50 mg tramadol intravenous injection with the calculation of the time for the first call of postoperative analgesia.
- Any detected complication as nausea and vomiting, pain on injection, or increased intraocular tension.
Read the detailed description
This prospective randomized double-blind study will be carried out on adult patients who will be presented for strabismus surgery in Ophthalmology Department in Tanta university hospitals over the 6-month duration, an informed written consent will be obtained from all the participants, all patients data will be confidential and will be used for the current study only.
The patients will be randomly allocated into two groups with the aid of computer-generated software of randomization. All the local anesthetic mixtures will be prepared under complete aseptic precautions by an anesthesia resident who will not participate in the study and will be blinded to its groups in to: - Group C (Control group) (20 Patients): Patients in this group will receive peribulbar anesthesia with a 10 ml local anesthetic mixture composed of 4 ml of plain bupivacaine 0.5%, 4 ml of lidocaine 2% containing 50 IU, and 2 ml normal saline.
Group R (rocuronium group) (20 patients): Patients in this group will receive peribulbar anesthesia with 10 ml local anesthetic mixture composed of 4 ml of plain bupivacaine 0.5%, 4 ml of lidocaine 2% containing 50 IU, and 0.06 mg/kg of rocuronium in 2 ml normal saline.
Anesthetic technique On arrival of patients to the pre-anesthesia preparation room, we will allow them to rest in a supine position with the connection of monitors that consist of 5 leads ECG, non-invasive blood pressure, pulse oximeter, and temperature. Also, intravascular access will be obtained.
Once the patient will be admitted to the operating theatre, all monitors will be applied. A nasal cannula was used at a flow rate of 2-4 l/min to supply oxygen to patients. The peribulbar block will be performed by the same anesthesiologist under aseptic precautions.
The technique of peribulbar block Disposable needles in a size of 25 gauge and 16mm bevels will be used to perform the peribulbar injection. The injection site will be limited by the lateral nasal margin laterally, inferior orbital margin inferiorly, and the lower lacrimal punctum superiorly. Once the needle introduced, the patient will be asked to look in the four cardinal directions of the gaze, superior, inferior, nasal, and temporal to ensure that the needle is not penetrating the eye globe, then negative aspiration will be done to exclude intravascular position of the needle, then, the peribulbar injection of the previously prepared local anesthetic mixture will be performed over 30 seconds and followed by the fullness of the eyelids.
The eyelids will be closed and covered by eye pads carefully with an application of 20 mmHg pressure through an intermittent application of Honan ball for 10 min. The intermittent eye compression will be relieved after 1 min, 3 min, 5 min, 7 min, 9 min, and 10 min to assess the onset and the quality of sensory and motor blockade. The sensory block will be assessed by the abolishment of corneal reflex to the installation of physiological drops on the cornea or conjunctiva. The onset of anesthesia will be determined by the time interval from local anesthetics injection and loss of corneal reflex. The motor block will be evaluated by asking the patient to open, close, and squeeze his eye (Lid Akinesia) and to move his eye globe in the four directions of the gaze (globe akinesia). The quality of akinesia will be assessed through the use of akinesia score where 0=inability to move (total akinesia), 1=partial movement (partial akinesia), and 2=full movements (no akinesia). This score was used to assess both lid akinesia and globe akinesia in the four directions with an overall score of 10.
The onset of lid akinesia will be calculated from peribulbar injection to the partial loss of ability to open or squeeze eyelids, while the onset of globe akinesia will be estimated from the injection of the local anesthetic mixture and partial loss of movement of the eye globe in the four cardinal directions. The surgery will be considered to be optimal to be started when the patient had corneal anesthesia together with partial lid and globe akinesia. The optimal time to start the surgery will be considered as the elapsed time between local anesthetics injection and satisfying the goals to start the surgery. The intraocular pressure will be measured preoperatively and immediately before initiating the surgery with detection of a number of patients with an increase in the intraocular tension (increase intraocular pressure more than 25 mmHg or by more than 10 mmHg than the preoperative value).
The duration of the sensory block will be estimated to be the time interval from the peribulbar injection till regaining corneal sensation, while, the duration of lid or globe akinesia will be determined by the time elapsed between performing the peribulbar injection and the full regaining of lid or globe movement respectively.
The primary outcome will be the duration of globe akinesia. Secondary outcomes will include the onset and duration of sensory block.
- Conditions
- Strabismus, Regional Anesthesia Morbidity, Rocuronium
- Being tested
- Normal saline, Rocuronium
- Keywords
- Strabismus, peribulbar anesthesia, rocuronium, akinesia
- Medical subject headings
- Strabismus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Normal salineDrug
peribulbar anesthesia with 10 ml local anesthetic mixture composed of 4 ml of plain bupivacaine 0.5%, 4 ml of lidocaine 2% containing 50 IU, and 2 ml normal saline.
RocuroniumDrug
peribulbar anesthesia with 10 ml local anesthetic mixture composed of 4 ml of plain bupivacaine 0.5%, 4 ml of lidocaine 2% containing 50 IU, and 0.06 mg/kg of rocuronium in 2 ml normal saline.
| Study group | Role | What they receive |
|---|---|---|
| Group C (Control group) | Placebo comparator | Patients in this group will receive peribulbar anesthesia with 10 ml local anesthetic mixture composed of 4 ml of plain bupivacaine 0.5%, 4 ml of lidocaine 2% containing 50 IU, and 2 ml normal saline. Receives: Drug: Normal saline |
| Group R (rocuronium group) | Experimental | Patients in this group will receive peribulbar anesthesia with 10 ml local anesthetic mixture composed of 4 ml of plain bupivacaine 0.5%, 4 ml of lidocaine 2% containing 50 IU, and 0.06 mg/kg of rocuronium in 2 ml normal saline. Receives: Drug: Rocuronium |
What is being measured
The primary outcome is the main question the study is designed to answer.
The duration of globe akinesia
Time interval from reaching the highest lid and globe akinesia score till restoration of the full lid and globe movement
Measured: up to first 2 hours intraoperative
Secondary outcomes (2)
The onset of sensory block
Time interval from peribulbar injection till loss of corneal sensation
Measured: Intraoperative (every 2 minutes after peribulbar injection)
The duration of sensory block
time interval from the peribulbar injection till regaining corneal sensation,
Measured: Intraoperative (Every 30 minutes in the first 4 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2021
- Study start3 Apr 2021
- Primary completion9 Feb 2025
- Study completion9 Feb 2025
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.
- More trials run by Tanta UniversityThe 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sameh Abdelkhalik Ahmed Ismaiel, Tanta University
- Investigators
- Sameh Abdelkhalik, M.D, Principal investigator, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04821817
- Sponsor's protocol ID
- 34506/2/21
- Status last verified
- Feb 2025
- First submitted
- 24 Mar 2021
- Last updated
- 13 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data of primary outcome will be available with the corresponding author till 6 months after approval of the publication of the trial.
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Rocuronium as an Anesthetic Adjuvant in Peribulbar Anesthesia for Adult Strabismus Surgery: Randomized Controlled Double-blind Study
- ClinicalTrials.gov ID
- NCT04821817
- Acronym / sponsor ID
- 34506/2/21
- Conditions
- Strabismus, Regional Anesthesia Morbidity, Rocuronium
- Keywords
- Strabismus, peribulbar anesthesia, rocuronium, akinesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 3 Apr 2021 (actual)
- Primary completion
- 9 Feb 2025 (actual)
- Study completion
- 9 Feb 2025 (actual)
- First posted
- 30 Mar 2021 (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.
- This is a prospective randomized clinical study that will be carried on adult patients aged from 21-60 years and presented for strabismus surgery under peribulbar anesthesia.
- Patients will be excluded if they refused to participate or had a contraindication to peribulbar anesthesia.
- Patients will be randomly distributed into either control group in which peribulbar anesthesia will be performed by injection of 10 ml local anesthetic mixture composed of 4 ml of plain bupivacaine 0.5%, 4 ml of lidocaine 2% containing 50 IU, and 2 ml normal saline or rocuronium group which peribulbar anesthesia will be performed by injection of 10 ml local anesthetic mixture composed of 4 ml of plain bupivacaine 0.5%, 4 ml of lidocaine 2% containing 50 IU, and 0.06 mg/kg of rocuronium in 2 ml normal saline.
- Measurements will include; -
- Patient age, weight, height, gestational age, and gravidity.
- The duration of globe akinesia (primary outcome).
- The onset of lid and globe akinesia and the duration of lid akinesia
- The onset and duration of sensory block
- Time required to start the surgery
- Akinesia score
- The visual analog score (VAS) which is composed of 0-10 score will be used to assess the severity of postoperative pain (where 0=no pain and 10=severe pain), The VAS score will be evaluated 1 h, 2 h postoperative, then every 2 h till 12 h. Any patients with VAS score more than 4 received rescue analgesia in the form of 50 mg tramadol intravenous injection with the calculation of the time for the first call of postoperative analgesia.
- Any detected complication as nausea and vomiting, pain on injection, or increased intraocular tension.
Detailed description
This prospective randomized double-blind study will be carried out on adult patients who will be presented for strabismus surgery in Ophthalmology Department in Tanta university hospitals over the 6-month duration, an informed written consent will be obtained from all the participants, all patients data will be confidential and will be used for the current study only.
The patients will be randomly allocated into two groups with the aid of computer-generated software of randomization. All the local anesthetic mixtures will be prepared under complete aseptic precautions by an anesthesia resident who will not participate in the study and will be blinded to its groups in to: - Group C (Control group) (20 Patients): Patients in this group will receive peribulbar anesthesia with a 10 ml local anesthetic mixture composed of 4 ml of plain bupivacaine 0.5%, 4 ml of lidocaine 2% containing 50 IU, and 2 ml normal saline.
Group R (rocuronium group) (20 patients): Patients in this group will receive peribulbar anesthesia with 10 ml local anesthetic mixture composed of 4 ml of plain bupivacaine 0.5%, 4 ml of lidocaine 2% containing 50 IU, and 0.06 mg/kg of rocuronium in 2 ml normal saline.
Anesthetic technique On arrival of patients to the pre-anesthesia preparation room, we will allow them to rest in a supine position with the connection of monitors that consist of 5 leads ECG, non-invasive blood pressure, pulse oximeter, and temperature. Also, intravascular access will be obtained.
Once the patient will be admitted to the operating theatre, all monitors will be applied. A nasal cannula was used at a flow rate of 2-4 l/min to supply oxygen to patients. The peribulbar block will be performed by the same anesthesiologist under aseptic precautions.
The technique of peribulbar block Disposable needles in a size of 25 gauge and 16mm bevels will be used to perform the peribulbar injection. The injection site will be limited by the lateral nasal margin laterally, inferior orbital margin inferiorly, and the lower lacrimal punctum superiorly. Once the needle introduced, the patient will be asked to look in the four cardinal directions of the gaze, superior, inferior, nasal, and temporal to ensure that the needle is not penetrating the eye globe, then negative aspiration will be done to exclude intravascular position of the needle, then, the peribulbar injection of the previously prepared local anesthetic mixture will be performed over 30 seconds and followed by the fullness of the eyelids.
The eyelids will be closed and covered by eye pads carefully with an application of 20 mmHg pressure through an intermittent application of Honan ball for 10 min. The intermittent eye compression will be relieved after 1 min, 3 min, 5 min, 7 min, 9 min, and 10 min to assess the onset and the quality of sensory and motor blockade. The sensory block will be assessed by the abolishment of corneal reflex to the installation of physiological drops on the cornea or conjunctiva. The onset of anesthesia will be determined by the time interval from local anesthetics injection and loss of corneal reflex. The motor block will be evaluated by asking the patient to open, close, and squeeze his eye (Lid Akinesia) and to move his eye globe in the four directions of the gaze (globe akinesia). The quality of akinesia will be assessed through the use of akinesia score where 0=inability to move (total akinesia), 1=partial movement (partial akinesia), and 2=full movements (no akinesia). This score was used to assess both lid akinesia and globe akinesia in the four directions with an overall score of 10.
The onset of lid akinesia will be calculated from peribulbar injection to the partial loss of ability to open or squeeze eyelids, while the onset of globe akinesia will be estimated from the injection of the local anesthetic mixture and partial loss of movement of the eye globe in the four cardinal directions. The surgery will be considered to be optimal to be started when the patient had corneal anesthesia together with partial lid and globe akinesia. The optimal time to start the surgery will be considered as the elapsed time between local anesthetics injection and satisfying the goals to start the surgery. The intraocular pressure will be measured preoperatively and immediately before initiating the surgery with detection of a number of patients with an increase in the intraocular tension (increase intraocular pressure more than 25 mmHg or by more than 10 mmHg than the preoperative value).
The duration of the sensory block will be estimated to be the time interval from the peribulbar injection till regaining corneal sensation, while, the duration of lid or globe akinesia will be determined by the time elapsed between performing the peribulbar injection and the full regaining of lid or globe movement respectively.
The primary outcome will be the duration of globe akinesia. Secondary outcomes will include the onset and duration of sensory block.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group C (Control group) | Placebo comparator | Drug: Normal salinePatients in this group will receive peribulbar anesthesia with 10 ml local anesthetic mixture composed of 4 ml of plain bupivacaine 0.5%, 4 ml of lidocaine 2% containing 50 IU, and 2 ml normal saline. |
| Group R (rocuronium group) | Experimental | Drug: RocuroniumPatients in this group will receive peribulbar anesthesia with 10 ml local anesthetic mixture composed of 4 ml of plain bupivacaine 0.5%, 4 ml of lidocaine 2% containing 50 IU, and 0.06 mg/kg of rocuronium in 2 ml normal saline. |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Adult patients
- Aged 21- 60 years
- American Society of Anesthesiologists class (ASA) I to III
- presented for elective strabismus surgery under peribulbar anesthesia.
Key exclusion criteria (8 listed)
- Patient refusal to participate.
- uncooperative patient.
- Neurological disorders.
- Psychological disorders
- Suspected or diagnosed coagulopathy.
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 |
|---|---|---|
| Normal salineperibulbar anesthesia with 10 ml local anesthetic mixture composed of 4 ml of plain bupivacaine 0.5%, 4 ml of lidocaine 2% containing 50 IU, and 2 ml normal saline. | Drug | Group C (Control group) |
| Rocuroniumperibulbar anesthesia with 10 ml local anesthetic mixture composed of 4 ml of plain bupivacaine 0.5%, 4 ml of lidocaine 2% containing 50 IU, and 0.06 mg/kg of rocuronium in 2 ml normal saline. | Drug | Group R (rocuronium group) |
Primary outcome
The duration of globe akinesia
Time frame: up to first 2 hours intraoperative
Time interval from reaching the highest lid and globe akinesia score till restoration of the full lid and globe movement
2 secondary outcomes
The onset of sensory block
Time frame: Intraoperative (every 2 minutes after peribulbar injection)
The duration of sensory block
Time frame: Intraoperative (Every 30 minutes in the first 4 hours)
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 13 Feb 2025.
- Individual participant dataSharing planned: Yes. The data of primary outcome will be available with the corresponding author till 6 months after approval of the publication of the trial.
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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.
Sameh Abdelkhalik, M.D principal investigator
Tanta University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Normal saline and Rocuronium in people with Strabismus and Regional Anesthesia Morbidity, run by Tanta University 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 4 inclusion and 8 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 13 Feb 2025. 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.
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 duration of globe akinesia (time frame: up to first 2 hours intraoperative). 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 13 Feb 2025.