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Trial registered on ANZCTR


Registration number
ACTRN12612000096853
Ethics application status
Approved
Date submitted
20/12/2011
Date registered
20/01/2012
Date last updated
20/01/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of electroacupuncture in postanaesthetic shivering during regional anaesthesia
Scientific title
electroacupuncture prevent postanesthetic shivering in patient undergone reginal anesthesia for ureteroendoscopy
Secondary ID [1] 273605 0
Chang Gung Memorial Hospital Institutional Review Board: 99-0358A3
Universal Trial Number (UTN)
U1111-1126-4344
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
postanesthetic shivering 285399 0
Condition category
Condition code
Anaesthesiology 285581 285581 0 0
Other anaesthesiology
Alternative and Complementary Medicine 285582 285582 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1.In active acupuncture group, trained and accredited acupuncturist performed acupuncture on ST36 and ST37 bilaterally in a depth not over 0.5 cun before anaesthesia. Then an electro-stimulator NihonRiko TOKKI MOEL III (NihonRiko Medical Co., Ltd., Nagasaki, Japan) was connected to the needles with a current of 1 mA and a frequency of 3 Hz for 30 minutes.
2. Subarachnoid anaesthesia was instituted at either L3/4 or L4/5 interspaces. Hyperbaric bupivacaine, 5 mg/ml, 15 mg was injected using a 25G Quincke spinal needle (B. Braun Melsungen AG, Melsungen, Germany). Both the intervention group and the sham group received spinal anaesthesia.
Intervention code [1] 283891 0
Prevention
Comparator / control treatment
In control group, needles were inserted at 4 points that are remote from any classically described meridian or extraordinary acupoint and (2) no current was applied to the needles. These 4 points were located as follows: 3 cm lateral to the ST36 and ST37 respectively bilaterally.
Control group
Placebo

Outcomes
Primary outcome [1] 286143 0
Shivering was graded using a scale similar to that validated by Tsai and Chu*: 0 = no shivering, 1 = piloerection or peripheral vasoconstriction but no visible shivering, 2 = muscular activity in only one muscle group, 3 = muscular activity in more than one muscle group but not generalized, and 4 = shivering involving the whole body.

*Tsai YC, Chu KS. A comparison of tramadol, amitriptyline, and meperidine for postepidural anesthetic shivering in parturients. Anesth Analg 2001; 93: 1288-92.
Timepoint [1] 286143 0
5-min intervals during surgery
Primary outcome [2] 286144 0
tympanic temperature as assessed using an infrared noncontact ear thermometer
Timepoint [2] 286144 0
Before intrathecal injection and 5-min intervals during the peri-operative period
Secondary outcome [1] 295229 0
blood pressure assessed using DINAMAP XL VITAL SIGNS MONITOR
Timepoint [1] 295229 0
before intrathecal injection and thereafter at 5, 10, 15, 20, 25 and 30 min
Secondary outcome [2] 295230 0
heart rate assessed using Electrocardiography monitoring
Timepoint [2] 295230 0
before intrathecal injection and thereafter at 5, 10, 15, 20, 25 and 30 min
Secondary outcome [3] 295231 0
artirial O2 saturation assessed using pulse oximeter
Timepoint [3] 295231 0
before intrathecal injection and thereafter at 5, 10, 15, 20, 25 and 30 min

Eligibility
Key inclusion criteria
subjects (ASA grade I or II) scheduled for elective ureterorendoscopy (URS) surgical procedures performed under spinal anaesthesia
Minimum age
20 Years
Maximum age
80 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Subjects with experience in acupuncture, with history of hypo- or hyperthyroidism, cardiopulmonary disease, psychological disorders, a need for blood transfusion during surgery, an initial body temperature >38.0°C or <36.0°C, a known history of alcohol or substance abuse, or receiving vasodilators, or medications likely to alter thermoregulation

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
A total number of 85 patients scheduled for elective ureteroendoscopy(URS) surgical procedures of either sex under spinal anaesthesia between June 2010 and May 2011 were prospectively included in the study.
All participants were randomly assigned to group A (electroacupuncture) or group P (placebo) on the basis of a concealed allocation approach (according to the computer random number table allocation group) using opaque sealed envelopes containing the randomization schedule. These envelopes were opened immediately before electroacupuncture. There were no restrictions on randomization. Two separated groups were invited to the study. The sealed envelopes were accessible only to the first group of acupuncturists who were to perform electroacupuncture. The second group of anesthetists who were to perform spinal anesthesia and patients were blinded to the electroacupuncture allocation. Another nursing staff unware of the electroacupuncture study were responsible for collection the necessary data.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer random number table allocation group
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 4020 0
Taiwan, Province Of China
State/province [1] 4020 0
Taoyuan

Funding & Sponsors
Funding source category [1] 284378 0
Self funded/Unfunded
Name [1] 284378 0
Yi-Chun Hsu
Address [1] 284378 0
Department of Anaesthesiology, Chang Gung memorial Hospital, Taoyuan, 333, Taiwan
Tel: +886-3-3281200
Fax: +886-3-3280097
Country [1] 284378 0
Taiwan, Province Of China
Primary sponsor type
Individual
Name
Yi-Chun Hsu
Address
Department of Anaesthesiology, Chang Gung memorial Hospital, Taoyuan, 333, Taiwan
Tel: +886-3-3281200
Fax: +886-3-3280097
Country
Taiwan, Province Of China
Secondary sponsor category [1] 283311 0
Individual
Name [1] 283311 0
Bo-Yan Yeh
Address [1] 283311 0
Department of Acupuncture and Traumatology, Chang Gung memorial Hospital, Taoyuan, 333, Taiwan
Tel: +886-3-3281200
Fax: +886-3-3280097
Country [1] 283311 0
Taiwan, Province Of China

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286336 0
Chang Gung Memorial Hospital Institutional Review Board
Ethics committee address [1] 286336 0
Chang Gung memorial Hospital, Taoyuan, 333, Taiwan
Tel: +886-3-3281200
Fax: +886-3-3280097
Ethics committee country [1] 286336 0
Taiwan, Province Of China
Date submitted for ethics approval [1] 286336 0
03/02/2010
Approval date [1] 286336 0
21/05/2010
Ethics approval number [1] 286336 0

Summary
Brief summary
Background: The aim of the present study was to verify the effect of electroacupuncture in the prevention of shivering caused by regional anaesthesia.

Methods: In this prospective, randomized, single-blind study, 80 ASA I and II patients undergoing urological surgery were included. Spinal anaesthesia was performed in all patients with bupivacaine 15 mg. The patients were randomly allocated to receive placebo acupuncture (Group P, n = 40) or electroacupuncture (group A, n = 40) for 30 min before spinal anaesthesia. Shivering score was recorded at 5 min intervals. Heart rate, arterial pressure and tympanic temperatures were recorded using standard non-invasive monitors before intrathecal injection and thereafter at 5, 10, 15, 20, 25 and 30 min.

Results: After 15 min, the number of patients with observed shivering above 3 was 13 in group P and 3 in group A. The number of patients with a shivering score above 3 was statistically significantly higher in group P compared with the other group.
Conclusion: The prophylactic use of electroacupuncture was effective in preventing shivering developed during regional anaesthesia.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33536 0
Address 33536 0
Country 33536 0
Phone 33536 0
Fax 33536 0
Email 33536 0
Contact person for public queries
Name 16783 0
Yi-Chun Hsu
Address 16783 0
Department of Anaesthesiology, Chang Gung memorial Hospital, Taoyuan, 333, Taiwan
Country 16783 0
Taiwan, Province Of China
Phone 16783 0
+886-3-3281200
Fax 16783 0
+886-3-3280097
Email 16783 0
megamanx@adm.cgmh.org.tw
Contact person for scientific queries
Name 7711 0
Yi-Chun Hsu
Address 7711 0
Department of Anaesthesiology, Chang Gung memorial Hospital, Taoyuan, 333, Taiwan
Country 7711 0
Taiwan, Province Of China
Phone 7711 0
+886-3-3281200
Fax 7711 0
+886-3-3280097
Email 7711 0
megamanx@adm.cgmh.org.tw

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary