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Chapter 12
All included patients were randomised by computer selection (RITA version 1.31) to
receive electro-acupuncture (EA), sham-acupuncture (SA), or placebo acupuncture (PA).
An independent investigator performed computer randomisation and preparation of the
numbered randomisation envelopes. These envelopes were opened by one of the two
acupuncturists who subsequently provided acupuncture. All three groups received sedation
with propofol and alfentanil by specialised sedation anaesthesia nurses. Colonoscopies
were performed either by a gastroenterologist resident or staff member.
All involved parties (patient, sedation anaesthesia nurse, endoscopist, endoscopic nurse,
and investigator) - with exception of the acupuncturists - were blinded to the intervention.
Procedure
After randomisation patients received an intravenous line, and glycopyrrolate 0.2 mg and
lidocaine 50 mg were given intravenously. Patients were provided with 2 l/min of oxygen
via a nasal cannula and monitored for heart rate (HR) and electrocardiogram (ECG), non-
invasive blood pressure (NIBP), oxygen saturation (SpO
2
) and expiratory carbon dioxide
tension (exCO
2
) as well as respiratory rate (RR). All parameters were documented at
5-minutes intervals.
Each group received sedation with propofol using a target controlled infusion (TCI) system
that has a weight and age adapted algorithm to attain a pre-set propofol plasma target level.
Sedation level was measured by means of the Observer’s Assessment of Alertness/Sedation
Scale (OAA/S).
20
If the patient was too alert to tolerate the procedure, additional sedation
was provided with step up of the TCI. Besides, patients were given 1.5 μg/kg alfentanil at
the beginning of the colonoscopy and an additional dose of 1.5 μg/kg alfentanil during
the procedure when experiencing pain. Acupuncture intervention took place after starting
propofol sedation and during the colonoscopy procedure. Haemodynamic or pulmonary
changes were classified as cardiorespiratory events if they lasted longer than 5 minutes.
Cardiorespiratory events were defined as: decline in SpO
2
< 90 % or breathing frequency <6
/min; a change in HR +/- 20 % or NIBP +/- 20 % of baseline or occurrence of any arrhythmia’s.
After the procedure patients were transported to the recovery unit and monitored with
ECG, NIPD, and SpO
2
. Level of recovery from sedation and the return of physical fitness were
assessed using the modified Aldrete Score
21
at 10, 30 and 60 min after arrival at the recovery
room. “Discharge criteria” required that an Aldrete Score ≥9 or equivalent to pre-procedure
score was met and the patient was alert and mobilised with stable haemodynamics.