Clinical trial NCT06748898: Effect of Transcutaneous Electrical Nerve Stimulation Based on Wrist-ankle Acupuncture Theory on EC50 of Remifentanil Inhibiting Responses to Tracheal Intubation Under General Anesthesia
Official title: Effect of Transcutaneous Electrical Nerve Stimulation Based on Wrist-ankle Acupuncture Theory on EC50 of Remifentanil Inhibiting Cardiovascular Response After Tracheal Intubation Under General Anesthesia
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Perioperative Analgesia
General Anaesthesia
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
First posted: 2024-12-27
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: During endotracheal tube insertion under general anesthesia, sympathetic nerve activity increases, which leads to increased heart rate, increased blood pressure, and increased catecholamine levels in the blood. It is important for patients to maintain hemodynamic stability during anesthesia induction and ultimately mitigate the cardiovascular stress response associated with tracheal intubation.

Transcutaneous Electrical Nerve Stimulation based on Wrist-Ankle Acupuncture theory (TENS-WAA) is a non-invasive pain treatment method, It has the advantages of easy wearing, concentrated treatment site, safe treatment and needle-free. To date, due to the lack of large-scale clinical use of TENS-WAA, only a few studies have reported the use of TENS-WAA for postoperative pain rehabilitation, especially for perioperative pain management. The aim of this study is to evaluate the median effective dose (ED50) of TENS-WAA for remifentanil inhibiting responses to tracheal intubation under general anesthesia, and to provide a reliable basis for its clinical promotion.


Eligibility criteria: Inclusion Criteria:

* Aged 18-64 years old;
* ASA grade I-Ⅲ;
* BMI≤30kg/m2.

Exclusion Criteria:

* Patients predicted to have difficult airways or those experiencing unsuccessful intubation processes;
* Individuals with psychiatric disorders, cognitive impairments, or other conditions that preclude cooperation;
* Patients who have received acupuncture treatment within the past three months or are undergoing routine acupuncture therapy;
* Individuals with a history of severe cardiovascular disease, hyperthyroidism, or asthma;
* Patients with contraindications to transcutaneous electrical nerve stimulation (TENS), including those with pacemakers, metallic implants, allergies to surface electrodes, skin sensory disorders, skin lesions, scars, or unhealed adhesions.

Primary outcomes:
measure: the half maximum effective concentration (EC50) of remifentanil
timeFrame: The remifentanil concentration was recorded for 2 minutes after successful tracheal intubation.
Secondary outcomes:
measure: The time required for tracheal intubation
timeFrame: The time consumed by this procedure was recorded from the beginning of intubation until completion of inflation of the endotracheal tube cuff
measure: Nausea and vomiting
timeFrame: 24 hour after surgery
measure: The dynamic VAS score
timeFrame: 24 hour after surgery
measure: QoR-15 questionnaire
timeFrame: 24 hour after surgery
measure: Postoperative airway complications
timeFrame: 24 hour after surgery
measure: Postoperative static pain (pain at rest)
timeFrame: 24 hour after surgery
Other outcomes:
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