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

NCT ID: NCT06748898

Last Updated: 2024-12-27

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-30
• Study Completion Date: 2025-04-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

T group

Patients received TENS-WAA with current stimulation

Group Type: EXPERIMENTAL

TENS-WAA

Intervention Type: 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.

C group

Patients received TENS-WAA without current stimulation

Group Type: SHAM_COMPARATOR

non TENS-WAA

Intervention Type: OTHER

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

Interventions

TENS-WAA

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.

Intervention Type: OTHER

non TENS-WAA

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

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Changhai Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jia-feng Wang

Associate Chief Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Yaqin Xiao, MM

Role: CONTACT

Phone: 15850599566

Email: 18752118213@163.com

Other Identifiers

TENS-WAA

Identifier Type: -

Identifier Source: org_study_id