Effect of Transcutaneous Electrical Nerve Stimulation Based on Wrist-ankle Acupuncture Theory on EC50 of Remifentanil Inhibiting Responses to Tracheal Intubation Under General Anesthesia

NCT06748898 | Completed DMC

• 1 other identifier: TENS-WAA
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Perioperative Analgesia; General Anaesthesia

Outcome Measures

Primary Outcomes (1)

• the half maximum effective concentration (EC50) of remifentanil

  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.

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

Secondary Outcomes (6)

• The time required for tracheal intubation

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

• Nausea and vomiting

  24 hour after surgery

• The dynamic VAS score

  24 hour after surgery

• QoR-15 questionnaire

  24 hour after surgery

• Postoperative airway complications

  24 hour after surgery

Study Arms (2)

T group

EXPERIMENTAL

Patients received TENS-WAA with current stimulation

Other: TENS-WAA

C group

SHAM COMPARATOR

Patients received TENS-WAA without current stimulation

Interventions

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.

T group

non TENS-WAA OTHER

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

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Changhai Hospital: lead

Study Sites (1)

Changhai Hospital

Shanghai, Yangpu, 200433, China

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Chief Doctor

Study Record Dates

• First Submitted: December 15, 2024
• First Posted: December 27, 2024
• Study Start: February 6, 2025
• Primary Completion: November 14, 2025
• Study Completion: November 14, 2025
• Last Updated: December 18, 2025

Record last verified: 2024-12

Locations

CN (1)