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.: PACTR201712002752134 Date of Approval: 08/11/2017
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of Dexmedetomidine or Fentanyl on recovery responses to Tracheal Extubation
Official scientific title Effect of Dexmedetomidine or Fentanyl on recovery responses to Tracheal Extubation in Vitrectomy
Brief summary describing the background and objectives of the trial Sixty patients of either sex, aged between 18-65 years old, ASA I & II, scheduled to undergo vitrectomy were enrolled in this prospective randomized double blind study. They divided into 3 groups, each group included 20 patients;, group I (control group) received 10 ml of normal saline IV five min before extubation , group II (fentanyl group) received 1 ¿g/kg fentanyl in 10 ml of normal saline IV five min before extubation, group III (Dexmedetomidine group) received 0.5 ¿g/kg IV dexmedetomidine in 10 ml of normal saline IV five min before extubation . The aim of this study was to evaluate the effect of dexmedetomidine or fentanyl on hemodynamic responses, extubation quality, IOP and postoperative sedation to tracheal extubation in vitrectomy
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied recovery responses to Tracheal Extubation
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 20/11/2013
Actual trial start date 20/11/2013
Anticipated date of last follow up 01/02/2014
Actual Last follow-up date 01/02/2014
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 60
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 radomisation table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
Parallel: different groups receive different interventions at same time during study Randomised Simple randomisation using a radomisation table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
Parallel: different groups receive different interventions at same time during study Randomised Simple randomisation using a radomisation table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used) Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group normal saline 10 ml of normal saline once five min before extubation placebo 20 Placebo
Experimental Group Dexmedetomidine 0.5 ug/kg in 10 ml of normal saline IV once five min before extubation Drug 20
Experimental Group fentanyl 1 ug/kg in 10 ml normal saline IV once five min before extubation Drug 20
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Sixty patients of either sex, aged between 18-65 years old, ASA I & II, scheduled to undergo vitrectomy patients with clinically significant cardiovascular, respiratory, hepatic diseases and epileptic and psychiatric patients, patient with known hypersensitivity to the study drugs, if there was pregnancy and lactation and if patient refusal 18 Year(s) 65 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 18/11/2013 ethical committee of faculty of medicine of El Minia university hospital
Ethics Committee Address
Street address City Postal code Country
General street Elminia 61519 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Intraocular pressure was measured on the non-operative eye in the supine position 10 min after anesthesia induction (baseline) 5min after administration of the drug study (at time of extubation) 5 min after extubation 10 min after extubation 20 min after extubation.
Secondary Outcome Heart rate, mean arterial pressure and extubation quality before induction, at the end of operation and 1, 3 min after drug administration, at extubation 1, 3, 5 and 10 min after extubation
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Elminia university hospital El Corniche street Elminia 611111 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Faculty of medicine general street El minia 61519 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of medicine El minia university general street El Minia 61519 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Dr Nagy Sayed Ali El Gomhoria Maghagha 16691 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohammed Mamdouh Elhiny elhiny2000@hotmail.com 01006862509 Borsayed
City Postal code Country Position/Affiliation
Elminia Egypt
Role Name Email Phone Street address
Public Enquiries Abeer Hassanin abeerhassanine@yahoo.com 01004234010 Elminia university hospital, Elminia faculty of Medicine
City Postal code Country Position/Affiliation
Elminia 611111 Egypt
Role Name Email Phone Street address
Scientific Enquiries Abeer Hassanin abeerhassanine@yahoo.com 00201004234010 Elminia university hospital, Elminia faculty of Medicine
City Postal code Country Position/Affiliation
Elminia 611111 Egypt
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
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information