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

Not Applicable

Not yet recruiting

• Conditions: Perioperative Analgesia; General Anaesthesia

• Registration Number: NCT06748898
• Lead Sponsor: Changhai Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-15
• Study First Submitted QC: 2024-12-23
• Last Update Submitted: 2024-12-23
• Study First Posted: 2024-12-27
• Last Update Posted: 2024-12-27
• Study Start: 2024-12-30
• Primary Completion: 2025-03-30
• Study Completion: 2025-04-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
the half maximum effective concentration (EC50) of remifentanil	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 6 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 Outcome Measures

Name	Time	Method
Postoperative airway complications	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
Postoperative static pain (pain at rest)	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.
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	defined as the time from the start of intubation to inflation of the bronchial tube cuff
The dynamic VAS score	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.
QoR-15 questionnaire	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
Nausea and vomiting	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).