Introduction: Propofol provides excellent sedation during colonoscopy. However, its application, namely when used together with an opioid, is associated with cardiopulmonary depression. Acupuncture is used nowadays for the treatment of pain and anxiety, and also to induce sedation. We hypothesised that electroacupuncture (EA) during colonoscopy would have sedative effects, thereby reducing propofol requirements to achieve an adequate level of sedation. Method: The study was designed and conducted as a single centre, patient and observer blinded, sham- and placebo-controlled randomised trial. Patients scheduled for elective colonoscopy under deep propofol/alfentanil sedation were randomly assigned to receive unilateral EA, sham-acupuncture (SA) or placebo-acupuncture (PA) at ST36, PC6 and LI4. The primary outcome parameter was the total dosage of propofol. Secondary outcomes included the patients’ and endoscopists’ satisfaction levels evaluated by questionnaires. Results: The dosage of propofol required (median [IQR]) was not significantly different between the three groups (EA group 147 μg/kg/min [109–193] vs SA group 141 μg/kg/min [123– 180] vs PA group 141 μg/kg/min [112–182]; P=0.776). There was also no significant difference in alfentanil consumption (P=0.634). Global satisfaction (median [IQR]) among patients (EA group 6.6 [6.0–7.0] vs SA group 6.8 [6.0–7.0] vs PA group 6.5 [6.0–7.0]; P=0.481) and endoscopists (6.0 [5.0–6.0] for all groups; P=0.773) did not significantly differ between the three groups. There was no significant difference in the number of cardiorespiratory events. Conclusion: For colonoscopy, the applied mode of EA did not show any propofol-sparing sedative effect compared with sham or placebo acupuncture. Trial registration: The trial is registered in the Netherland’s Trial Registry (NTR4325).
BackgroundThe number of colonoscopies tremendously increased in recent years and will further rise in the near future. Because of patients’ growing expectation on comfort during medical procedures, it is not surprising that the demand for sedation also expands. Propofol in combination with alfentanil is known to provide excellent analgosedation, however, its use is associated with respiratory and cardiovascular depression. Acupuncture could be a technique to reduce drug requirement while providing the same level of sedation and analgesia.Methods/designThe study will be performed as a single centre, randomised, placebo controlled trial. 153 patients scheduled for propofol/alfentanil sedation during colonoscopy will be randomly assigned to receive electroacupuncture (P6, ST36, LI4), sham acupuncture, or placebo acupuncture. Following endoscopy patients and gastroenterologists have to fill in questionnaires about their sedation experiences. Additionally, patients have to accomplish the Trieger test before and after the procedure. Patient monitoring includes time adapted HR, SpO2, ECG, NIBP, exCO2, OAA/S, and the Aldrete score. The primary outcome parameter is the dosage of propofol necessary for an adequate level of sedation to tolerate the procedure (OAA/S < 4). Effectiveness of sedation, classified by satisfaction levels measured by questionnaires is the secondary outcome parameter.DiscussionModerate to deep sedation using propofol is increasingly applied during colonoscopies with a high satisfaction level among patients despite well-known hemodynamic and respiratory side effects of this hypnotic agent. Acupuncture is known to attenuate gastrointestinal discomfort and pain. We hypothesize that the combination of conventional sedation techniques with acupuncture may result in equally satisfied patients with a lower risk of respiratory and hemodynamic events during colonoscopies.Trial registrationThis trial is registered in the Nederland’s Trial Register NTR 4325.The first patient was randomized on 13 February 2014.
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