- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06371131
Effect of Stellate Ganglion Block on Postoperative Nausea and Vomiting
Effect of Right⁃Stellate Ganglion Block on Postoperative Nausea and Vomiting in Patients Undergoing Thyroid Surgery
Study Overview
Status
Intervention / Treatment
Detailed Description
Postoperative nausea and vomiting is one of the most common postoperative complications second only to postoperative pain. Studies have reported that without any antiemetic prevention treatment, the overall incidence of PONV in surgical operations is up to 20-30%, and the incidence of PONV in high-risk patients such as thyroid surgery is even up to 70-80%. The pathogenesis of postoperative nausea and vomiting is very complex, including central, peripheral receptors and multiple nerve pathways. When peripheral receptors are stimulated, the signal passes through the afferent nerve to the vomiting center, causing nausea and vomiting. The emetic chemical receptors are rich in many receptors, which can directly feel various toxins, metabolites or drugs in the blood and cerebrospinal fluid, project signals to the nerve center and then spread to the cerebral cortex, causing nausea and vertigo, or transmit signals along the vagus nerve, glossopharyngeal nerve, spinal nerve, etc. to the digestive tract, diaphragm and abdominal wall muscles, resulting in the opening of the sphincter in the upper esophagus and strong contraction of the diaphragm. Abdominal muscles contract, so that the stomach pressure increases, stomach contents through the digestive tract is expelled from the body, vomiting.
Thyroid, as the endocrine organ of human body, mainly secretes thyroid hormone and participates in human metabolism. With the progress of modern medical technology, although thyroid postoperative complications have decreased, due to the limited operating space of thyroid surgery, in order to fully exposed the surgical field of vision and facilitate the operation of surgeons, patients often take the cervical hyperextension position, that is, patients take the supine position with high shoulder pads. Tilt your head back so that your lower jaw, trachea, and sternum are at the same level, allowing the thyroid gland to protrate forward as much as possible. Although this position is easy for surgeons to operate, due to the complex anatomical structure around the thyroid gland, adjacent to important blood vessels and nerves, this position often causes thyroid surgical position syndrome in patients, that is, nausea and vomiting, dizziness, headache, tinnitus, neck radiation pain and other symptoms, which not only increases patients' pain, but also seriously reduces patients' medical experience.
Stellate ganglion block has been proved to be widely used in clinic and can play a positive role in multiple organs and systems of the whole body. In clinical work, stellate ganglion block is more widely used in the treatment of various pain, autonomic nerve disorders and other diseases. However, there are few clinical studies on whether stellate ganglion block can be used as an effective and feasible means to prevent postoperative nausea and vomiting and the related mechanisms to prevent the possible occurrence of nausea and vomiting. Therefore, this study will explore the preventive effect of stellate ganglion block on postoperative thyroid nausea and vomiting, and hope to explore its possible mechanism, so as to provide more effective and feasible methods for clinical prevention of postoperative nausea and vomiting and improve patients' medical comfort and satisfaction.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: ling Dan, BD
- Phone Number: 86 13983072922
- Email: 302069@hospital.cqmu.edu.cn
Study Locations
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Chongqing
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Chongqing, Chongqing, China, 400000
- Recruiting
- The Second Affiliated Hospital of Chongqing Medical University
-
Contact:
- ling Dan, BD
- Phone Number: 86 13983072922
- Email: 302069@hospital.cqmu.edu.cn
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Receiving thyroid surgery under general anesthesia
- Age ≥18 years and ≤ 70 years
- American Society of Anesthesiologists(ASA) physical status classification I-III.
- Voluntary participation and ability to understand and sign the informed consent form.
Exclusion Criteria:
- Patients with obesity(BMI>30 kg/m2)
- contraindicated to stellate ganglion block
- Patients who cannot cooperate with the study for any reason, or whom the investigator deems unsuitable for inclusion in this trial.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Right stellate ganglion block
Right -stellate ganglion block was given 30minutes before anesthesia induction.
|
The experimental group was given right stellate ganglion block 30 minutes before anesthesia induction
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No Intervention: Blank control group
No treatment was given 30 minutes before anesthesia induction
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of Postoperative nausea and vomiting
Time Frame: From end of surgery to 24 hours after surgery
|
Postoperative nausea and vomiting is evaluated by follow-up
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From end of surgery to 24 hours after surgery
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of Postoperative nausea and vomiting during preemptive analgesia
Time Frame: From 0-10 min after preemptive analgesia
|
Postoperative nausea and vomiting is evaluated by investigator's follow-up
|
From 0-10 min after preemptive analgesia
|
Intensity of nausea and vomiting during preemptive analgesia
Time Frame: From 0-10 min after preemptive analgesia
|
Intensity of nausea and vomiting is evaluated by numeric rating scale (0-10), which higher socre represents more uncomfortable
|
From 0-10 min after preemptive analgesia
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Intensity of nausea and vomiting during hospitalization
Time Frame: From end of surgery to 24 hours after surgery
|
Intensity of nausea and vomiting is evaluated by numeric rating scale (0-10), which higher socre represents more uncomfortable
|
From end of surgery to 24 hours after surgery
|
Hemodynamic parameters after preemptive analgesia
Time Frame: From 0-10 min after preemptive analgesia
|
Systolic blood pressure,dastolic blood pressure,mean arterial pressure,heart rate,oxygen saturation,Patient state index
|
From 0-10 min after preemptive analgesia
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Postoperative pain intensity
Time Frame: From end of surgery to 24 hours after surgery
|
Postoperative pain intensity is assessed by numeric rating scale (0-10), which higher socre represents more uncomfortable
|
From end of surgery to 24 hours after surgery
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Recovery of gastrointestinal function
Time Frame: From end of surgery to 24 hours after surgery
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Gastrointestinal function is is assessed by the evacuation time
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From end of surgery to 24 hours after surgery
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Sleep quality
Time Frame: From end of surgery to 1 day after surgery
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Sleep quality is is assessed by numeric rating scale (0-10), which higher socre represents better sleep quality
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From end of surgery to 1 day after surgery
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Satisfaction score and postoperative analgesia satisfaction score
Time Frame: From end of surgery to hospital discharge with about 5 days
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Satisfaction score and postoperative analgesia satisfaction score is assessed by numeric rating scale (0-10), which higher socre represents more uncomfortable
|
From end of surgery to hospital discharge with about 5 days
|
Collaborators and Investigators
Investigators
- Principal Investigator: ling Dan, BD, The Second Affiliated Hospital of Chongqing Medical University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PONV of Thyroid Surgery
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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