NCT05159674

Brief Summary

Studies have shown that the use of dexmedetomidine before and during surgery has a good sedative, analgesic and circulatory stabilizing effect. The use of dexmedetomidine in thoracoscopic lung resection has been proven to be safe and feasible, and it has a certain degree of improvement in postoperative lung function. Combining the advantages of thoracoscopy and the previous experience of combined acupuncture and drug anesthesia technology, our team pioneered cardiopulmonary surgery without endotracheal intubation and combined needle and drug anesthesia, so that the patient was in a state of light sleep and spontaneous breathing without tracheal intubation. After completing the operation, it was found that this technical method can effectively reduce the amount of intraoperative anesthetics, improve intraoperative lung ventilation, improve lung oxygenation, achieve intraoperative organ protection, and significantly reduce complications caused by tracheal intubation , Postoperative analgesic drugs have reduced the amount of 20%, accelerate the time of exhaust and defecation, and its postoperative rehabilitation is better than conventional treatment. These results suggest that the combination of acupuncture and medicine is not only suitable for anesthesia, it can be used scientifically and rationally in postoperative analgesia, immune regulation and even the entire perioperative organ protection, creating more possibilities for patients' ERAS. In combined acupuncture and drug anesthesia, the core goal is to use acupuncture to reduce the insufficiency of anesthetics in terms of analgesia, sedation, stable circulation, and protection of organs. However, the mechanism of action behind this type of combination has not yet been improved. Efficacy kinetics or pharmacokinetics has been explained convincingly, or it is not well recognized. For example, is there a specific target in the body of acupuncture? If there is a specific target, where is the effect target? If the combined application of acupuncture and medicine produces a synergistic effect through a pharmacokinetic mechanism, its specific mechanism still needs to be clarified.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2021

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 30, 2021

Completed
15 days until next milestone

Study Start

First participant enrolled

December 15, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 16, 2021

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2023

Completed
Last Updated

December 16, 2021

Status Verified

November 1, 2021

Enrollment Period

1.8 years

First QC Date

November 30, 2021

Last Update Submit

December 10, 2021

Conditions

Keywords

AcupunctureDexmedetomidineCombined anesthesiaMetabolic enzyme

Outcome Measures

Primary Outcomes (1)

  • Time required for bispectral index of EEG to be less than 80

    The time required for bispectral index of EEG in the intervention group was lower than that in the non intervention group

    From the time anesthesia was given until the end time of the surgery

Study Arms (2)

Dexmedetomidine+electroacupuncture compound anesthesia

EXPERIMENTAL

EA was given every day three days before surgery, 30 minutes before induction of anesthesia + the whole course of surgery, and every 12 hours from the first day after surgery, each treatment was performed for 30 minutes until 48 hours after surgery. During the operation, only dexmedetomidine was used to make BIS\<80.

Device: Dexmedetomidine+electroacupuncture compound anesthesia

Dexmedetomidine anesthesia

NO INTERVENTION

There was no EA treatment before, during or after operation. During the operation, only dexmedetomidine was used to make BIS\<80.

Interventions

Dexmedetomidine and acupuncture were given together to induce anesthesia

Dexmedetomidine+electroacupuncture compound anesthesia

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with pulmonary nodules scheduled for thoracoscopic surgery;
  • Age ≥ 18 and ≤ 75, regardless of gender;
  • Understand and agree to participate in this study and sign the informed consent form.

You may not qualify if:

  • Patients who have previously received EA treatment;
  • Patients with skin infection at acupoints;
  • Patients with nerve injury of upper or lower limbs;
  • Those who have participated or are participating in other clinical trials one month before enrollment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 30, 2021

First Posted

December 16, 2021

Study Start

December 15, 2021

Primary Completion

September 15, 2023

Study Completion

December 15, 2023

Last Updated

December 16, 2021

Record last verified: 2021-11