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A PROSPECTIVE PLACEBO-CONTROLLED RANDOMISED TRIAL
12
INTRODUCTION
The number of colonoscopies has increased in recent years and will continue to rise further
due to national cancer screening programs. Colonoscopies are known to be uncomfortable
for patients. Pain, vasovagal reactions, or uncooperative behaviour of patients can
compromise screening correctness.
1
Therefore, sedation with analgo-sedative drugs is
often requested in these procedures.
2
Propofol has become the standard for sedation during endoscopic procedures due to
its rapid onset and termination of action.
3-5
However, the most important disadvantage
of propofol-based sedation is the risk of unintentional deep sedation leading to
cardiorespiratory depression, especially when combined with an opioid.
6-9
Adjuvant methods might be suitable to lower the dosage of propofol while keeping the
same level of sedation, thereby minimising the risks of cardiopulmonary side effects.
Acupuncture is used worldwide for various indications, with the most promising evidence
shown so far for treatment of pain, postoperative nausea, and vomiting (PONV).
10-15
Electro-
acupuncture facilitates standardisation of acupuncture and provides better analgesia
compared to manual stimulation of acupuncture points.
16
We hypothesised that electro-acupuncture at Stomach 36 (ST36), Pericardium 6 (PC6), and
Large Intestine (LI4) during colonoscopies has sedative effects, thereby reducing the dosage
of propofol required to achieve an adequate level of sedation. Secondary objective was
patient and endoscopist satisfaction level with the combination of electro-acupuncture
and propofol sedation for the respective procedures.
METHODS
We performed a prospective, patient and observer blinded, sham- and placebo-controlled
randomised trial reported following the STRICTA (Standards for Reporting Interventions in
Clinical Trials of Acupuncture) reporting guidelines
17
and the CONSORT statement.
18
Ethical
approval was obtained from the Medical Ethics Committee of the Academic Medical Centre,
Amsterdam, the Netherlands (NL36861.018.11) on 6 May 2013. The trial is registered in the
Netherland’s Trial Registration (NTR4325). The study protocol was published in 2015.
19
The
study was supported by institutional funding.
The study took place at the Department of Gastroenterology and Hepatology at the
Academic Medical Centre (AMC), Amsterdam, the Netherlands, in the period between
February 2014 and February 2017. Patients scheduled for an elective diagnostic or
therapeutic colonoscopy with propofol sedation, aged above 18 years, ASA classification
I-III, and a written informed consent were eligible. Patients were excluded if they were aged
less than 18 years, had ASA classification IV and V, nickel allergy, implanted pacemaker
devices, psychiatric or neurologic disorders, used anticoagulants, or refused sedation.