Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201701001957330 Date of Approval: 02/01/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Acupuncture in laparoscopic cholecystectomy
Official scientific title Acupuncture as an anti-emetic in laparoscopic cholecystectomy prospective, Randomized control trial
Brief summary describing the background and objectives of the trial Postoperative nausea and vomiting (PONV) are the most common postoperative complication after general anesthesia, with an incidence of approximately 30%. The true incidence of PONV is difficult to determine because of the lack of a single stimulus of onset as well as the range of possible etiologies (medical, surgical, and patient and anesthesia associated). In the absence of antiemetic treatment, the incidence of PONV is estimated to be 25% to 30% for all surgical interventions and patient populations.2 However, the incidence rate of PONV after laparoscopic cholecystectomy (LC) is higher than that after other types of surgery. PONV can cause significant morbidity including dehydration, electrolyte imbalance, suture tension and dehiscence, venous hypertension and bleeding, esophageal rupture, and life-threatening airway compromise, although the more severe complications are rare. PONV increases medical cost Limited efficacy and side effects with antiemetics led to the use of alternative treatment. Researches in various countries believe acupuncture improves the quality of patients¿ life We suppose that intraoperative acupuncture is a safe effective method for reducing PONV so we will compare the effect of intraoperative acupuncture with a routine approach we use in general anesthesia for laparoscopic cholecystectomy as regard incidence of PONV. Hypothesis and aim of the work We hypothesis that intraoperative acupuncture is a safe effective method for reducing PONV The primary outcome will be degree of PONV assessed by Verbal Descriptive Scale(VDS) while secondary outcomes will be post-operative need for antiemetics
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Laparoscopic cholecyctectomy,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 03/01/2017
Actual trial start date 03/01/2017
Anticipated date of last follow up 04/02/2017
Actual Last follow-up date 04/02/2017
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 60
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomisation using a radomisation table created by a computer software program Numbered containers Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group control regular anesthesia induction and maintenance operation time local daily practice 30 Active-Treatment of Control Group
Experimental Group Acupuncture one 30 minutes neui guan puncture point 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Adult patients scheduled for elective laparoscopic cholecystectomy Patients with conditions (including pharmacological treatments) that might impair gastrointestinal motility, gastro-esophageal reflux, and those who had the potential for difficult airway management will be therefore excluded. Additional exclusion criteria are history of motion sickness 18 Year(s) 60 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 10/01/2017 institutional review board mansoura faculty of medicin
Ethics Committee Address
Street address City Postal code Country
elgomhuria street mansoura 35511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Secondary Outcome need for postoperative anti emetic for 24 hours
Primary Outcome verbal describtive scale to detect post operative nausea and vomiting at post anesthesia care unit and 2, 4, 8 , 12 and 24 hours at ward
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
mansoura gastrointestinal surgery centre gihan street mansoura 35516 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
mansoura faculty of medicine gihan street mansoura 35516 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor gastrointestinal surgery centre mansoura university gihan street mansoura 35516 Egypt Hospital
Primary Sponsor mansoura faculty of medicine gihan street mansoura 35516 Egypt University
COLLABORATORS
Name Street address City Postal code Country
usama abdalla gihan street mansoura 35516 Egypt
emad elhefnawy gihan street mansoura 35516 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator usama abdalla usamaelsayed20@yahoo.com +201028842265 gihan street
City Postal code Country Position/Affiliation
mansoura 35516 Egypt lecturer of anesthesia and intensive care
Role Name Email Phone Street address
Public Enquiries alrefaey kandeel refa3y2@yahoo.com +201028842265 gihan street
City Postal code Country Position/Affiliation
mansoura 35516 Egypt lecturer of anesthesia and intensive care
Role Name Email Phone Street address
Scientific Enquiries emad elhefnawy emadhefnawy@yahoo.com +201028842265 gihan street
City Postal code Country Position/Affiliation
mansoura 35516 Egypt lecturer of anesthesia and intensive care
REPORTING
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Changes to trial information