Effect of Acupuncture on sedation requirement during Colonoscopy
(EAcCo)

The number of endoscopic gastroenterological procedures tremendously increased
in recent years and will further rise in the near future. In our study we will
focus on colonoscopies.
Patients undergoing such interventions expect a safe and in particular
comfortable manner of riding out those routine procedures. It is thus not
surprising that the demand for sedation during endoscopic procedures by the
patient and by the endoscopist has increased nowadays. One standard regime
(propofol/alfentanil sedation provided by an anaesthesia nurse) is known to
provide excellent sedation. However, the combination propofol/alfentanil could
be associated with respiratory and cardiovascular depression. Therefore, other
methods that induce an adequate level of sedation without respiratory
depression or those measures able to decrease the dosage of propofol/alfentanil
are of increasing interest to clinicians. Addition of acupuncture could be one
possible option.
Acupuncture is a safe procedure without major complications. It is accepted by
the WHO for indications such as pain therapy, treatment of anxiety,
sleeplessness, and fearful disorders.

We hypothesize that acupuncture reduces the dosage of sedatives for
colonoscopies. We will compare three groups to test our hypothesis. One group
will receive verum-acupuncture, another group sham-acupuncture and the third
group will be the control group. All three groups will receive standard
sedation with propofol/alfentanil.
Primary endpoint of the study is the dosage propofol used for colonoscopies in
combination with a standard dosage of alfentanil in the verum- and the control
group. The third group (sham acupuncture) is necessary to test if there is any
placebo effect produced by acupuncture itself, as it is often mentioned and
associated in acupuncture treatments in pain therapy.
Secondary endpoint is patient and gastroenterologists satisfaction with the
procedure, determined with a questionnaire.

The study will be performed as an blinded randomized controlled trial.

Patients will be studied during the endoscopic procedure, where they will be
included in one of three different acupuncture regimes, with verum, sham- and
placebo acupuncture. In total every patient will be needled with six needles
and treated with electro-acupuncture during the colonoscopy.

Measurements that will be made during colonoscopy reflect common clinical
practice. Patients have to fill in questionnaires before and after the
intervention and have to perform the Trieger test.
Acupuncture is a safe procedure without complications.