NCT06371131

Brief Summary

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%. PONV not only increased discomfort and prolonged hospital stay; Severe cases can lead to wound dehysis, acid-base imbalance, water and electrolyte metabolism disorders, seriously affect the prognosis of patients. Although various prevention and treatment measures have been adopted in clinical practice, it still cannot be completely eliminated. Therefore, postoperative nausea and vomiting of thyroid is still a concern in clinical anesthesia work, so it is urgent to explore more simple and effective measures to prevent thyroid PONV. SGB is the injection of local anesthetics into loose connective tissue containing stellate ganglion. It has a clear effect on postoperative analgesia of thyroid surgery, and can play a certain role in preventing thyroid PONV by reducing the application of perioperative opioids. Few studies have reported that the incidence of PONV can be significantly reduced after the application of SGB in patients with thyroid surgery, which provides a certain basis for the prevention of thyroid PONV. Therefore, this study aims to explore the effect of right stellate ganglion block on preventing postoperative nausea and vomiting of thyroid, and to explore the possible mechanism of action.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 17, 2023

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

April 14, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 17, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2024

Completed
Last Updated

April 26, 2024

Status Verified

April 1, 2023

Enrollment Period

1.1 years

First QC Date

April 14, 2024

Last Update Submit

April 24, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Incidence of Postoperative nausea and vomiting

    Postoperative nausea and vomiting is evaluated by follow-up

    From end of surgery to 24 hours after surgery

Secondary Outcomes (8)

  • Incidence of Postoperative nausea and vomiting during preemptive analgesia

    From 0-10 min after preemptive analgesia

  • Intensity of nausea and vomiting during preemptive analgesia

    From 0-10 min after preemptive analgesia

  • Intensity of nausea and vomiting during hospitalization

    From end of surgery to 24 hours after surgery

  • Hemodynamic parameters after preemptive analgesia

    From 0-10 min after preemptive analgesia

  • Postoperative pain intensity

    From end of surgery to 24 hours after surgery

  • +3 more secondary outcomes

Study Arms (2)

Right stellate ganglion block

EXPERIMENTAL

Right -stellate ganglion block was given 30minutes before anesthesia induction.

Procedure: Right -stellate ganglion block

Blank control group

NO INTERVENTION

No treatment was given 30 minutes before anesthesia induction

Interventions

The experimental group was given right stellate ganglion block 30 minutes before anesthesia induction

Right stellate ganglion block

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Patients with obesity(BMI\>30 kg/m2)
  • contraindicated to stellate ganglion block

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Second Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400000, China

RECRUITING

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsNauseaSigns and Symptoms, DigestiveSigns and SymptomsVomiting

Study Officials

  • ling Dan, BD

    The Second Affiliated Hospital of Chongqing Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Experimental group: right stellate ganglion block 30 minutes before anesthesia induction.Control group: No treatment was given 30minutes before anesthesia induction.Data was recorded at the corresponding time points.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 14, 2024

First Posted

April 17, 2024

Study Start

April 17, 2023

Primary Completion

May 30, 2024

Study Completion

August 30, 2024

Last Updated

April 26, 2024

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will share

all IPD that underlie results in a publication

Locations