Reflex, OculocardiacNCT04950881
Cervical Vagus Nerve Block Prevents Ocularvagal Reflex
A study testing Ultrasound guided vagus nerve block and Bradycardia Treatment in people with Reflex, Oculocardiac, run by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University at 1 site in China.
Trial summary
In ophthalmic surgery, surgical operations such as pulling certain eye tissues or compressing the eyeball often leads to bradycardia, arrhythmia even cardiac arrest, bradypnea, nausea and vomiting and elevated blood sugar level. The condition is called the ocularvagal reflex (OVR). Read more about this study
- Who is it for?
- Ages 16 to 70 years
- Conditions the study is for
- Reflex, Oculocardiac
- What is being tested?
- Ultrasound guided vagus nerve block and Bradycardia Treatment
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2021to 31 Mar 2023
- 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 16 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients received surgeries with high-risk OVR, including the strabismus surgery, the posterior scleral reinforcement, and the insertion of ocular implant.
Who cannot join
- Those who have pre-existed vocal cord damage before surgery (such as hoarseness, electronic laryngoscopy shows fixed vocal cords or arytenoid cartilage dislocation).
- Those with a history of surgery on the both sides of the neck (eg, thyroidectomy, carotid endarterectomy).
- American Society of Anesthesiologist (ASA) Grade > 3
- Patients with infection at the neck puncture site, or severe coagulation abnormalities before surgery, or a history of local anesthetic allergy, or who have a pacemaker.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Daping Hospital, Army Medical University
Chongqing, Chongqing Municipality, 400042
Qingxiang Mao, Ph.D., 02368729729, maomaosmmu@126.com
About this study
Official title: Ultrasound-guided Cervical Vagus Nerve Block Prevents Ocularvagal Reflex in Ophthalmic Surgery
In ophthalmic surgery, surgical operations such as pulling certain eye tissues or compressing the eyeball often leads to bradycardia, arrhythmia even cardiac arrest, bradypnea, nausea and vomiting and elevated blood sugar level. The condition is called the ocularvagal reflex (OVR). Traditionally, when the bradycardia or arrhythmia happens, the operation has to be suspended, and atropine or isoproterenol is given intravenously to treat the bradycardia. Vagus nerve block may be an effective way to prevent and alleviate this vagal reflex. However it is difficult to perform the nerve block with anatomical landmark (blind) methods. In this study, the investigators used ultrasound-guided right cervical vagus nerve block to reduce the incidence of the OVR. The researchers hypothesized that low concentrations of lidocaine or ropivacaine can block the right cervical vagus nerve and reduce the incidence of intraoperative OVR. Researchers evaluated the changes of heart rate, blood pressure, oxygen saturation, and airway pressure in patients undergoing high-risk OVR surgery.
- Conditions
- Reflex, Oculocardiac
- Being tested
- Ultrasound guided vagus nerve block, Bradycardia Treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound guided vagus nerve blockProcedure or surgery
Before the operation starts, patients received the ultrasound guided vagus nerve block. A 50mm Braun nerve stimulation needle is guided by the ultrasonic beam to insert into the carotid sheath and 10ml of lidocaine or ropivacaine is injected.
Bradycardia TreatmentDrug
If the OVR happens because the surgical stimulation, the operation suspends and atropine (0.01-0.02mg/kg) or isoproterenol (1-2 μg/per time)is given intravenously to increase the heart rate.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Sham comparator | Conventional monitor and treatment The surgery is performed after patient is under general anesthesia. If patient's heart rate significantly slows down or bradycardia/arrhythmia happens, the surgeon will be asked to suspend the operation. Meanwhile, atropine (0.01-0.02mg/kg) is given intravenously to increase the heart rate. If atropine fails to increase the heart rate, isoproterenol (1-2 μg/per time) will be given intravenously to increase the heart rate. Receives: Drug: Bradycardia Treatment |
| Nerve block group | Experimental | After the patient is under general anesthesia, an attending physicians perform the ultrasound-guided cervical vagus nerve block (using a 50mm Braun nerve stimulation needle, and the patients were injected with 10ml of lidocaine or ropivacaine ). Then the operation starts. If patient's heart rate significantly slows down or bradycardia/arrhythmia happens, the surgeon will be asked to suspend the operation. Meanwhile, atropine (0.01-0.02mg/kg) is given intravenously to increase the heart rate. If atropine fails to increase the heart rate, isoproterenol (1-2 μg/per time) will be given intravenously to increase the heart rate. After endotracheal tube is removed, the patient will be followed up for next 24 hours. Receives: Procedure: Ultrasound guided vagus nerve block; Drug: Bradycardia Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of heart rate
Changes of heart rate in beat per minute from Baseline
Measured: during the operation
Secondary outcomes (5)
Changes of Blood pressure
Changes of systolic blood pressure in mmHg from Baseline
Measured: during the operation
Changes of Peak airway pressure
Changes of Blood pressure in mmHg from Baseline
Measured: during the operation
Changes of SpO2
Changes of SpO2 in percentage in mmHg from Baseline
Measured: during the operation
Nausea and vomiting in times
Measured: 24 hours after the operation
Voice changes in grades (0-3)
Changes of Voice changes in grades (0-3) from Baseline. 0 means good, 2 means moderate change of voice, 3 means hoarse voice
Measured: 24 hours after the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2021
- Study start1 Jul 2021
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Mar 2023 (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 Reflex, OculocardiacStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qingxiang Mao, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04950881
- Sponsor's protocol ID
- 2021-55
- Status last verified
- Feb 2022
- First submitted
- 20 Jun 2021
- Last updated
- 21 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Casutt M, Breitenmoser I, Werner L, Seelos R, Konrad C. Ultrasound-guided carotid sheath block for carotid endarterectomy: a case series of the spread of injectate. Heart Lung Vessel. 2015;7(2):168-176.
PubMed 26157743Arnold RW, Bond AN, McCall M, Lunoe L. The oculocardiac reflex and depth of anesthesia measured by brain wave. BMC Anesthesiol. 2019 Mar 14;19(1):36. doi: 10.1186/s12871-019-0712-z.
PubMed 30871507
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-guided Cervical Vagus Nerve Block Prevents Ocularvagal Reflex in Ophthalmic Surgery
- ClinicalTrials.gov ID
- NCT04950881
- Acronym / sponsor ID
- 2021-55
- Conditions
- Reflex, Oculocardiac
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical UniversityUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Mar 2023 (estimated)
- First posted
- 6 Jul 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.
In ophthalmic surgery, surgical operations such as pulling certain eye tissues or compressing the eyeball often leads to bradycardia, arrhythmia even cardiac arrest, bradypnea, nausea and vomiting and elevated blood sugar level. The condition is called the ocularvagal reflex (OVR). Traditionally, when the bradycardia or arrhythmia happens, the operation has to be suspended, and atropine or isoproterenol is given intravenously to treat the bradycardia. Vagus nerve block may be an effective way to prevent and alleviate this vagal reflex. However it is difficult to perform the nerve block with anatomical landmark (blind) methods. In this study, the investigators used ultrasound-guided right cervical vagus nerve block to reduce the incidence of the OVR. The researchers hypothesized that low concentrations of lidocaine or ropivacaine can block the right cervical vagus nerve and reduce the incidence of intraoperative OVR. Researchers evaluated the changes of heart rate, blood pressure, oxygen saturation, and airway pressure in patients undergoing high-risk OVR surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Sham comparator | Drug: Bradycardia TreatmentConventional monitor and treatment The surgery is performed after patient is under general anesthesia. If patient's heart rate significantly slows down or bradycardia/arrhythmia happens, the surgeon will be asked to suspend the operation. Meanwhile, atropine (0.01-0.02mg/kg) is given intravenously to increase the heart rate. If atropine fails to increase the heart rate, isoproterenol (1-2 μg/per time) will be given intravenously to increase the heart rate. |
| Nerve block group | Experimental | Procedure: Ultrasound guided vagus nerve block, Drug: Bradycardia TreatmentAfter the patient is under general anesthesia, an attending physicians perform the ultrasound-guided cervical vagus nerve block (using a 50mm Braun nerve stimulation needle, and the patients were injected with 10ml of lidocaine or ropivacaine ). Then the operation starts. If patient's heart rate significantly slows down or bradycardia/arrhythmia happens, the surgeon will be asked to suspend the operation. Meanwhile, atropine (0.01-0.02mg/kg) is given intravenously to increase the heart rate. If atropine fails to increase the heart rate, isoproterenol (1-2 μg/per time) will be given intravenously to increase the heart rate. After endotracheal tube is removed, the patient will be followed up for next 24 hours. |
Who may qualify
- Ages
- 16 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients received surgeries with high-risk OVR, including the strabismus surgery, the posterior scleral reinforcement, and the insertion of ocular implant.
Key exclusion criteria (4 listed)
- Those who have pre-existed vocal cord damage before surgery (such as hoarseness, electronic laryngoscopy shows fixed vocal cords or arytenoid cartilage dislocation).
- Those with a history of surgery on the both sides of the neck (eg, thyroidectomy, carotid endarterectomy).
- American Society of Anesthesiologist (ASA) Grade > 3
- Patients with infection at the neck puncture site, or severe coagulation abnormalities before surgery, or a history of local anesthetic allergy, or who have a pacemaker.
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 |
|---|---|---|
| Ultrasound guided vagus nerve blockBefore the operation starts, patients received the ultrasound guided vagus nerve block. A 50mm Braun nerve stimulation needle is guided by the ultrasonic beam to insert into the carotid sheath and 10ml of lidocaine or ropivacaine is injected. | Procedure or surgery | Nerve block group |
| Bradycardia TreatmentIf the OVR happens because the surgical stimulation, the operation suspends and atropine (0.01-0.02mg/kg) or isoproterenol (1-2 μg/per time)is given intravenously to increase the heart rate. | Drug | Control group, Nerve block group |
Primary outcome
Changes of heart rate
Time frame: during the operation
Changes of heart rate in beat per minute from Baseline
5 secondary outcomes
Changes of Blood pressure
Time frame: during the operation
Changes of Peak airway pressure
Time frame: during the operation
Changes of SpO2
Time frame: during the operation
Nausea and vomiting in times
Time frame: 24 hours after the operation
Voice changes in grades (0-3)
Time frame: 24 hours after the operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2022.
- Background: PubMed 26157743Casutt M, Breitenmoser I, Werner L, Seelos R, Konrad C. Ultrasound-guided carotid sheath block for carotid endarterectomy: a case series of the spread of injectate. Heart Lung Vessel. 2015;7(2):168-176.
- Background: PubMed 30871507Arnold RW, Bond AN, McCall M, Lunoe L. The oculocardiac reflex and depth of anesthesia measured by brain wave. BMC Anesthesiol. 2019 Mar 14;19(1):36. doi: 10.1186/s12871-019-0712-z.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound guided vagus nerve block and Bradycardia Treatment in people with Reflex, Oculocardiac, run by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University at 1 site in China.
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 4 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 21 Feb 2022. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of heart rate (time frame: during the operation). 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 NCT04950881, 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 21 Feb 2022.