Cervical Vagus Nerve Block Prevents Ocularvagal Reflex

Reflex, Oculocardiac Clinical Trial

Official title:

Ultrasound-guided Cervical Vagus Nerve Block Prevents Ocularvagal Reflex in Ophthalmic Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04950881
• Other study ID #: 2021-55
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2021
• Est. completion date: March 31, 2023

Study information

• Verified date: February 2022
• Source: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: March 31, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Reflex, Oculocardiac

Intervention

Procedure:
• 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.

Drug:
• 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.

Locations

Country	Name	City	State
China	Daping Hospital, Army Medical University	Chongqing	Chongqing

Sponsors (1)

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

Country where clinical trial is conducted

China, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes of heart rate	Changes of heart rate in beat per minute from Baseline	during the operation
Secondary	Changes of Blood pressure	Changes of systolic blood pressure in mmHg from Baseline	during the operation
Secondary	Changes of Peak airway pressure	Changes of Blood pressure in mmHg from Baseline	during the operation
Secondary	Changes of SpO2	Changes of SpO2 in percentage in mmHg from Baseline	during the operation
Secondary	Nausea and vomiting in times		24 hours after the operation
Secondary	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	24 hours after the operation