Clinical trial NCT04950881: Cervical Vagus Nerve Block Prevents Ocularvagal Reflex
Official title: Ultrasound-guided Cervical Vagus Nerve Block Prevents Ocularvagal Reflex in Ophthalmic Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Reflex, Oculocardiac
Lead sponsor: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Sponsor class: OTHER
First posted: 2021-07-06
Enrollment: 60
Sex: ALL
Minimum age (years): 16
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Changes of heart rate
timeFrame: during the operation
Secondary outcomes:
measure: Changes of Blood pressure
timeFrame: during the operation
measure: Changes of Peak airway pressure
timeFrame: during the operation
measure: Changes of SpO2
timeFrame: during the operation
measure: Nausea and vomiting in times
timeFrame: 24 hours after the operation
measure: Voice changes in grades (0-3)
timeFrame: 24 hours after the operation
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Daping Hospital, Army Medical University
state: Chongqing
Study officials:
References:
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.
citation: 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.