Cervical Vagus Nerve Block Prevents Ocularvagal Reflex

NCT ID: NCT04950881

Last Updated: 2022-02-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-01
• Study Completion Date: 2023-03-31

Brief 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). 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Control group

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.

Group Type: SHAM_COMPARATOR

Bradycardia Treatment

Intervention Type: DRUG

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.

Nerve block group

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.

Group Type: EXPERIMENTAL

Ultrasound guided vagus nerve block

Intervention Type: PROCEDURE

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 Treatment

Intervention Type: DRUG

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.

Interventions

Ultrasound guided vagus nerve block

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.

Intervention Type: PROCEDURE

Bradycardia Treatment

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patients received surgeries with high-risk OVR, including the strabismus surgery, the posterior scleral reinforcement, and the insertion of ocular implant.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

OTHER

Sponsor Role: lead

Responsible Party

Qingxiang Mao

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Daping Hospital, Army Medical University

Chongqing, Chongqing Municipality, China

Site Status: RECRUITING

Countries

China

Facility Contacts

Qingxiang Mao, Ph.D.

Role: primary

maomaosmmu@126.com

02368729729

References

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.

Reference Type: BACKGROUND

PMID: 26157743 (View on PubMed)

Arnold 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.

Reference Type: BACKGROUND

PMID: 30871507 (View on PubMed)

Other Identifiers

2021-55

Identifier Type: -

Identifier Source: org_study_id