Cervical Vagus Nerve Block Prevents Ocularvagal Reflex

NCT04950881 | Unknown

• 1 other identifier: 2021-55
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Changes of heart rate

  Changes of heart rate in beat per minute from Baseline

  during the operation

Secondary Outcomes (5)

• Changes of Blood pressure

  during the operation

• Changes of Peak airway pressure

  during the operation

• Changes of SpO2

  during the operation

• Nausea and vomiting in times

  24 hours after the operation

• Voice changes in grades (0-3)

  24 hours after the operation

Study Arms (2)

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.

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.

Procedure: Ultrasound guided vagus nerve block; Drug: Bradycardia Treatment

Interventions

Ultrasound guided vagus nerve block 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.

Nerve block group

Bradycardia Treatment 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.

Control group; Nerve block group

Eligibility Criteria

• Age: 16 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Daping Hospital, Army Medical University

Chongqing, Chongqing Municipality, 400042, China

RECRUITING

Related Publications (2)

• 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.

  PMID: 26157743 BACKGROUND

• 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.

  PMID: 30871507 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: June 20, 2021
• First Posted: July 6, 2021
• Study Start: July 1, 2021
• Primary Completion: December 31, 2022
• Study Completion: March 31, 2023
• Last Updated: February 21, 2022

Record last verified: 2022-02

Locations

CN (1)