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Can acupuncture improve sedation during colonoscopie


- candidate number15905
- NTR NumberNTR4325
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR18-dec-2013
- Secondary IDsNL 41966.018.12
- Public TitleCan acupuncture improve sedation during colonoscopie
- Scientific TitleEffect of acupuncture on sedation requirement during colonoscopy
- ACRONYMEAcCo
- hypothesisThe number of colonoscopies tremendously increased in recent years and will further rise in the near future. Patients undergoing such interventions expect a safe and in particular comfortable manner of riding out those routine procedures. 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.
- Healt Condition(s) or Problem(s) studiedSedation, Colonoscopy,
- Inclusion criteriaEligible patients for participation in this clinical trial are those planned to undergo elective diagnostic or therapeutic colonoscopy. The patients must comply with the following criteria in order to be eligible to participate in this clinical study: Age range °› 18 years, ASA classification I °ßC III. Written informed consent.
- Exclusion criteriaAge range < 18 years, ASA classification IV or higher Nickel allergy (acupuncture needles), Pacemaker (Application of electroacupuncture) psychiatric and neurologic disorders, use of anticoagulants
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 7-jan-2014
- planned closingdate1-okt-2014
- Target number of participants153
- InterventionsThe patients will be randomized into one of the three arms.
All patients will receive a validated questionnaire to fill in before procedure and perform the Trieger test as a measure of psychomotoric function.
Group 1 will receive sedation with Propofol TCI/Alfentanil by anaesthesia nurse to achieve the targeted sedation score (Observer°Įs Assessment of Alertness/Sedation Scale °‹4) plus Verum-Acupuncture.
Group 2 will receive sedation with Propofol TCI/Alfentanil by anaesthesia nurse to achieve the targeted sedation score (Observer°Įs Assessment of Alertness/Sedation OAAS Scale °‹4) plus Sham-Acupuncture. The needles for Sham-acupuncture will be placed 1 cm upper the respective acupoints for the Verum-Acupuncture.
Group 3 will receive Propofol TCI/Alfentanil by anaesthesia nurse to achieve the targeted sedation score (OAAS Scale °‹4) plus Placebo-Acupuncture with Streitberger needles at the respective acupuncture points . The Streitberger needle looks like a real needle and appears as though the skin is being penetrated, even though it is not. This guarantees that anaesthesia nurse and patient stay blinded (Streitberger et al., 1998).
Patients in all three groups will be monitored using SO2, ECG, and capnography, reflecting common practice. At arrival in the recovery room patients will be monitored by pulse oximetry (SO2), ECG and NIBP only (standard praxis). All patients will stay in the recovery room for 1 hour. At arrival, 10, 20, 30 and 60 min later virtual discharge will be determined based on Aldrete Score.
- Primary outcomeReduction of sedatives for colonoscopies by using additional acupuncture compared to sedation alone.
- Secondary outcomePatients's satisfaction after colonoscopy by using additional acupuncture compared to sedation alone.
- TimepointsArrival recovery unit (pre procedure):
Patient (part 1) questionnaire, Trieger Test Colonoscopy procedure:
Sedation regime 1, 2, or 3
Monitoring using SO2, ECG, NIBP, capnography, Face mask with 2-8 l O2
Recovery room (post procedure):
Aldrete score (10, 20, 30, 60 min)
30 min: Patient (part 2a) questionnaire, Trieger Test
60 min: Patient: Trieger Test
Demission recovery room:
Patient (part 2b) questionnaire
Next day: Interview with patient by phone (part 2 c questionnaire)
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMD, MA, DEAA B. Preckel
- CONTACT for SCIENTIFIC QUERIESMD, MA, DEAA B. Preckel
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC)
- PublicationsN/A
- Brief summaryThe number of colonoscopies increased in recent years and will further rise in the near future. Patients undergoing such interventions expect a safe and in particular comfortable manner of riding out those routine procedures. 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. 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, the second 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.
Secondary endpoint is patient and gastroenterologists satisfaction with the procedure, determined with a questionnaire. The study will be performed as an open-label randomized controlled trial.
Study population:
Patients undergoing elective diagnostic or therapeutic colonoscopy, °› 18 years, ASA classification I ®C III.
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.
- Main changes (audit trail)
- RECORD18-dec-2013 - 8-jan-2014


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