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Completed

NCT Number: 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

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.

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Key information

Conditions

Perioperative Analgesia General Anaesthesia

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Changhai Hospital

Shanghai, Yangpu, 200433, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

TENS-WAA

Other

Before anesthesia induction, two paired of electrode pads will be placed on the upper area 1 and 2 with the skin of the treatment area exposed, and the upper and lower juxtaposition method will be adopted. The electrodes were placed close to the skin and connected with TENStem eco basic (Wuxi Jiajian Medical Device Co., Ltd.). Upper area 2 is at the middle of the palmar side of the forearm, between the palmaris longus and flexor carpi radialis.Upper area 1 is between the ulnar border on the little finger side and the flexor carpi ulnaris tendon.Stimulation parameters of TENS-WAA are alternating dense-disperse wave with a frequency of 2Hz and a pulse width of 200μs, and a frequency of 100Hz with a pulse width of 150μs, alternating every 3 seconds ，intensity required to reachthe maximum tolerable level without causing pain, continuous stimulation until the end of surgery.

non TENS-WAA

Other

Before anesthesia induction, two paired of electrode pads will be placed on the same position without current stimulation.

Primary outcomes

  1. the half maximum effective concentration (EC50) of remifentanil

    Time frame: The remifentanil concentration was recorded for 2 minutes after successful tracheal intubation.

    Dixon's up-and-down method was used to determine the remifentanil concentration, starting from 3.0 ng/mL (step size of 0.2 ng/mL). After obtaining 7 infection points from positive to negative endotracheal intubation reactions, patient recruitment was terminated. A positive response to endotracheal intubation was defned as MAP 15% above the basal level or HR 15% above the basal level within 2 min of endotracheal intubation. The EC50 of remifentanil Ce was determined by calculating the average of the midpoint dose of all independent pairs of patients after six crossover points were obtained.

Secondary outcomes

  1. The time required for tracheal intubation

    Time frame: The time consumed by this procedure was recorded from the beginning of intubation until completion of inflation of the endotracheal tube cuff

    defined as the time from the start of intubation to inflation of the bronchial tube cuff

  2. Nausea and vomiting

    Time frame: 24 hour after surgery

    Postoperative nausea and vomiting was assessed by visual analogue scale (VAS) : a 10-cm ruler was used as a scale, with 0 at one end indicating no nausea and vomiting, and 10 at the other end indicating the most severe nausea and vomiting that could not be tolerated (1-4 as mild, 5-6 as moderate, 7-10 as severe).

  3. The dynamic VAS score

    Time frame: 24 hour after surgery

    Independent investigators will assess the postoperative dynamic pain (pain during activities or coughing) by utilizing a visual analogue scale (VAS) ranging from 0 to 10. The two ends of the straight line represent "no pain at all" and "the worst pain imaginable," respectively. Patients are required to mark their corresponding position on the line based on their perception of pain, and the numerical value corresponding to this position serves as the patient's pain score.

  4. QoR-15 questionnaire

    Time frame: 24 hour after surgery

    The 15-item QoR score is used to asses quality of recovery after surgery which ranges 0-150 and higher QoR-15 scores indicate better postoperative recovery

  5. Postoperative airway complications

    Time frame: 24 hour after surgery

    Postoperative airway complications such as hoarseness, sore throat, and difficulty in pronunciation are assessed by researchers during postoperative follow-up visits to check for the presence of related complications and to record the findings

  6. Postoperative static pain (pain at rest)

    Time frame: 24 hour after surgery

    Postoperative static pain (pain at rest) will be quantified by utilizing a visual analogue scale (VAS) ranging from 0 to 10. The two ends of the straight line represent "no pain at all" and "the worst pain imaginable," respectively. Patients are required to mark their corresponding position on the line based on their perception of pain, and the numerical value corresponding to this position serves as the patient's pain score.

Sponsors and collaborators

Lead sponsor

Changhai Hospital

Other

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Dec 27, 2024
Registry last updated
Dec 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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