The Effect of TEAS on the Quality of Early Recovery

NCT02619578 | Completed

• 1 other identifier: A14-30323
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

During the past four decades, gynecologic laparoscopy has evolved from a limited method to an advanced operative approach that frequently serves as a substitute for laparotomy. The advantages of laparoscopy over laparotomy include less postoperative pain, shorter hospital stays, and reduced blood loss. However, in the surgery CO2 increases the intra-abdominal and intrathoracic pressure, which leads to cardiac output decrease and increases sympathetic activity in a reflex. On the other hand, CO2 accumulation in the body leads to hypercapnia, which indirectly stimulates aortic body chemosensory organs and carotid sinus, increasing the concentration of plasma catecholamines, cortisol and vasopressin , these responses have an important impact on patient recovery after surgery. Acupuncture is an ancient Chinese method to treat diseases and relieve pain. Transcutaneous electrical acupoint stimulation (TEAS), a noninvasive adjunctive intervention based on acupuncture, has been widely accepted and used worldwide. To date, multiple studies have demonstrated TEAS could reduce intra-operative opioid drugs consumption, reduce the incidence of postoperative nausea and vomiting (PONV) and improve postoperative cognitive function. However, whether TEAS could improve the quality of early recovery after gynecologic laparoscopy is unknown. In this study we therefore investigated the effects of TEAS at the acupoints of Baihui (GV20), Yingtang (EX-HN3), Zusanli (ST36) and Neiguan (PC6) on the quality of early recovery in the patients undergoing gynecological laparoscopic surgery.

Conditions

C.Delivery; Surgery (Previous), Gynecological; Inappropriate Device Stimulation of Tissue; Delayed Emergence From Anesthesia

Keywords

Transcutaneous electric acupoint stimulation (TEAS); gynecological laparoscopic surgery; QoQ-40; MMSE; VAS

Outcome Measures

Primary Outcomes (1)

• Scores on QoR-40

  Quality of recovery was assessed using a 40-item questionnaire as a measure of quality of recovery (QoR-40; maximum score 200) scoring system performed on preoperative day 1(T0), postoperative day 1 (T1) and postoperative day 2 (T2).

  1 year

Secondary Outcomes (2)

• Scores on MMSE

  1 year

• Scores on VAS

  1 year

Other Outcomes (9)

• The incidence of nausea and vomiting

  1 year

• The incidence postoperative pain medications

  1 year

• The incidence postoperative antiemetics

  1 year

Study Arms (2)

TEAS Group

OTHER

TEAS consisted of 30 min of stimulation (12-15 mA, 2/100 Hz) at the Hegu (L14) and Neiguan (PC6) before anesthesia. Anesthesia was induced i.v. with propofol (2 mg kg-1) and remifentanil (1 μg kg-1) using a target-controlled infusion (TCI) system. After loss of consciousness, vecuronium (0.1 mg kg-1) was administered i.v. Patients' lungs were mechanically ventilated in a volume-controlled mode with a tidal volume of 8ml kg-1 body weight during the operation.

Other: TEAS; Drug: propofol, remifentanil, vecuronium; Other: mechanical ventilation

Con Group

OTHER

The patients in the Con group had the electrodes applied at the same acupoints, but received no stimulation. Anesthesia was induced i.v. with propofol (2 mg kg-1) and remifentanil (1 μg kg-1) using a target-controlled infusion (TCI) system. After loss of consciousness, vecuronium (0.1 mg kg-1) was administered i.v. Patients' lungs were mechanically ventilated in a volume-controlled mode with a tidal volume of 8ml kg-1 body weight during the operation.

Other: Con; Drug: propofol, remifentanil, vecuronium; Other: mechanical ventilation

Interventions

TEAS OTHER

According to the theory of traditional Chinese medicine, bilateral Baihui (GV20), Yingtang (EX-HN3), Zusanli (ST36) and Neiguan (PC6) were chosen as the acupuncture points. These acupoints were identified according to the traditional anatomic localization . Gel electrodes were applied to the skin after it had been cleaned with ethyl alcohol. The acupoints were then stimulated electrically with an intensity of 12-15 mA and dense-disperse frequency of 2/100 Hz for 30 min, using the Hwato electronic acupuncture treatment instrument (model No. SDZ-V, Suzhou Medical Appliances Co., Ltd, Suzhou, China). The intensity was adjusted to maintain a slight twitching of local muscles according to individual maximum tolerance, indicating a satisfactory of De-Qi phenomenon and thus adequate stimulation.

TEAS Group

Con OTHER

The patients in the Con group had the electrodes applied at the same acupoints, but received no stimulation.

Con Group

propofol, remifentanil, vecuronium DRUG

Anesthesia was induced i.v. with propofol (2 mg kg-1) and remifentanil (1 μg kg-1) using a target-controlled infusion (TCI) system. After loss of consciousness, vecuronium (0.1 mg kg-1) was administered i.v.

Con Group; TEAS Group

mechanical ventilation OTHER

Patients' lungs were mechanically ventilated in a volume-controlled mode with a tidal volume of 8ml kg-1 body weight during the operation.

Con Group; TEAS Group

Eligibility Criteria

• Age: 29 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients undergoing elective gynecological laparoscopic surgery.
• ASA physical status of I-II.
• Ages ranged from 29-60 yr.

You may not qualify if:

• Recent use of TEAS or acupuncture.
• Neural damage or infection along the meridian at which the acupoints lay.
• Use of antiemetic in the previous week.
• Regular use of opioids.
• Hepatic dysfunction.
• Confirmed renal impairment. Diabetes mellitus Cognitive dysfunction Conversion to laparotomy during gynecologic laparoscopy.

Sponsors & Collaborators

• Guizhou Provincial People's Hospital: lead

Related Publications (1)

• Yu X, Zhang F, Chen B. The effect of TEAS on the quality of early recovery in patients undergoing gynecological laparoscopic surgery: a prospective, randomized, placebo-controlled trial. Trials. 2020 Jan 8;21(1):43. doi: 10.1186/s13063-019-3892-4.

  PMID: 31915045 DERIVED

MeSH Terms

Conditions

Delayed Emergence from Anesthesia

Interventions

Propofol; Remifentanil; Vecuronium Bromide; Respiration, Artificial

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Propionates; Acids, Acyclic; Carboxylic Acids; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Androstanols; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Airway Management; Therapeutics; Resuscitation; Emergency Treatment; Respiratory Therapy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2015
• First Posted: December 2, 2015
• Study Start: November 1, 2013
• Primary Completion: July 1, 2014
• Study Completion: November 1, 2014
• Last Updated: December 2, 2015

Record last verified: 2015-11