This prospective randomized, double-blind, clinical trial was registered in the Iranian Registry of Clinical Trials (IRCT2017071710599N17) and approved by the ethics committee of Iran University of Medical Sciences in Tehran, Iran (
18). The study was conducted on 51 adult (18 - 60 years old) participants who were scheduled for elective short (30 - 120 minutes) surgeries under general anesthesia from 2017-08-13 to 2018-02-19 in a training hospital, Tehran, Iran.
Inclusion criteria were defined as: consent to participate in the study; ASA score I and II; non neurosurgical surgeries; non pregnant; no anatomical abnormalities or infection in acupuncture sites; without history of neurological condition, psychiatric disorders, addiction, cardiac arrhythmia, hypertension, diabetes (type I and II), coagulopathy, allergy to propofol, and head trauma. Patients were excluded from study in case of hypotension more than 10 minutes during surgery; blood loss more than 250 cc during surgery; surgery time less than 30 minutes or more than 120 minutes.
After selecting patients according to inclusion criteria, informed consent was taken. Patients were transferred to operating room and monitored by heart rate, non-invasive blood pressure and pulse oximetry. End tidal CO2 (EtCO2) and BIS (BIS VISTA™ Monitoring System, Norwood, USA) were measured during and after surgery. BIS values were recorded every 5 minutes during surgery.
The same anesthesia protocol was applied to all patients (premedication: midazolam 0.01 mg/kg and fentanyl 2 μ/kg, induction: propofol 2 mg/kg, muscle relaxant: cisatracurium 0.2 mg/kg, maintenance of anesthesia with infusion of propofol and remifentanil to keep BIS value within 40 - 60). Mechanical ventilation was employed by tidal volume of 8 - 10 mL/kg and adjusting respiratory rate to maintain EtCO2 within 30 - 35 mmHg. Before the end of surgery, Apotel 1 gr/IV was administrated. At the end of surgery, residual neuromuscular block was reversed by neostigmine 0.04 mg/kg and atropine 0.02 mg/kg and anesthesia administration was stopped.
At the end of surgery, patients were assigned to one of three groups by block randomization according to a computer generated random list. First group (A) acupuncture on K1, DU26 acupoints, second group (B) acupuncture on K1, DU25 acupoints and third group (C) sham acupuncture on lateral margin of both feet in the level of K1 (perpendicular insertion,0.5 - 0.7 cm deep) and apex of chin (oblique transverse-up insertion, 0.2 - 0.5 cm deep) (
Figure 4), and acupuncture was performed accordingly for twenty minutes.
Disposable sterile acupuncture needles (Dongbang Medical Co., Korea) were used (0.25 × 25 mm for K1 and feet sham acupuncture and 0.18 × 15 mm for face). Needles were stimulated manually according to acupuncture practice by expert acupuncturist and patients did not receive any sensory or verbal stimulations.
BIS values at end of surgery, 5th minute, 10th minute, 15th minute and 20th minute after the end of surgery (BIS0, BIS5, BIS10, BIS15, and BIS20, respectively) were recorded as well as time of extubation and time of eye opening. Extubation was performed by the anesthesiologist in charge of patients who was not involved in the study and was not aware of acupuncture practice and study setting. Data collection was made by a resident in anesthesiology who was also not involved in the study and not aware of acupuncture practice and study setting. Needles were removed before transferring patient to post anesthesia care unit.
3.1. Statistical Analysis
The collected data was analyzed using SPSS for Windows 20.0 (IBM Corporation, Armonk, NY, USA). Continuous data are shown as mean ± standard deviation and categorical data are shown as number (%). Categorical data was analyzed by chi-square test. Data had normal distribution according to Kolmogorov-Smirnov test. The ANOVA one-way test or repeated measure ANOVA was performed to analyze continuous data as appropriate. Scheffe post hoc test were used for multiple comparisons between groups. The null hypothesis was rejected at alpha (P values) less than 0.05.