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.: PACTR201601001407281 Date of Approval: 02/01/2016
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Dexmedetomidine versus magnesium in thoracoscopy.
Official scientific title Dexmedetomidine versus Magnesium Sulphate as a Co-analgesic in Video-assisted Thoracoscopy
Brief summary describing the background and objectives of the trial Video-assisted thocic surgery continues to gain acceptance for diagnostic and therapeutic procedures involving the lung or adjacent organs. Video-assisted thoracoscopic surgery (VATS), which is known to be less invasive than conventional thoracotomies, causes little pain and better preservation of pulmonary function. While (VATS) procedures are still associated with a significant amount of postoperative pain Opioids are the principle analgesic, but it can have several well-known dose related side effects Dexmedetomidine is a potent and highly selective ¿2 adrenoreceptor agonist with sympatholytic, sedative, amnesic, and analgesic properties Magnesium is a non-competitive (NMDA) receptor antagonist with antinociceptive effects. Objective: To compare the efficacy of dexmedetomidine versus magnesium sulphate in video-assisted thoracoscopic surgeries, regarding the reduction of opioid consumption.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied ,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 02/05/2015
Actual trial start date 02/05/2015
Anticipated date of last follow up 07/11/2015
Actual Last follow-up date 21/11/2015
Anticipated target sample size (number of participants) 50
Actual target sample size (number of participants) 50
Recruitment status Completed
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
Parallel: different groups receive different interventions at same time during study Randomised simple randomisation using a table sealed envelope Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group dexmedetomidine got Initial loading dose of dexmedetomidine 1 µg/kg over 30 min before induction, followed by an infusion of 0.5 µg/kg/hr till end of surgery iv dexmedetomidine infusion 25
Control Group magnesium Initial loading dose of magnesium sulphate 40 mg/kg over 30 min before induction, followed by an infusion started at 10 mg/kg/hr. till end of surgery iv magnesium infusion 25 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
ASA physical status I or II Ages ranged from 18 to 60 years inability to use the PCA device renal or hepatic dysfunction cardiac failure ischemic or valvular heart disease long-term use of certain medications (ß-blockers, analgesics, sedatives or tricyclic antidepressants) Psychiatric illness alcohol abuse emergency surgery Pregnancy moderate to severe obstructive or restrictive respiratory disease 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 09/08/2015 IRB-NCI
Ethics Committee Address
Street address City Postal code Country
fom khalig cairo 11796 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The total dose of postoperative morphine consumption 1st and 2nd day postoperatively.
Secondary Outcome visual analogue scale (VAS) for pain intenon , Heart rate, oxygen saturation (SpO2), and mean arterial pressure (MAP) were recorded at specific time points (every five minutes) during the surgical procedure.:- the 1st and 2nd day postoperatively
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
national cancer institute, cairo university 1 kasr eini st cairo 12211
FUNDING SOURCES
Name of source Street address City Postal code Country
national cancer institute 1 kasr eini st cairo 12211 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor national cancer institute 1 kasr eini st cairo 12211 Egypt University
COLLABORATORS
Name Street address City Postal code Country
mohamed elramely 21 zizinia city, new cairo cairo 11853 Egypt
tamer kotb 21 mohamed eid st hadayek elmaadi cairo 11643 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator mohamed elramely mramely@hotmail.com 00201005125124 21 zizinia city, new cairo
City Postal code Country Position/Affiliation
cairo 11853 Egypt lecturer of anesthesia and pain management, Cairo University
Role Name Email Phone Street address
Public Enquiries mohamed elramely mramely@hotmail.com 00201005125124 21 zizinia city, new cairo
City Postal code Country Position/Affiliation
cairo 11853 Egypt lecturer of anesthesia and pain management, Cairo University
Role Name Email Phone Street address
Scientific Enquiries tamer kotb tamerkotb862@yahoo.com 00201006570683 21 mohamed eid hadayek elmaadi
City Postal code Country Position/Affiliation
cairo 11643 Egypt lecturer of anesthesia and pain management, Cairo University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information