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.: PACTR201801002914411 Date of Approval: 28/12/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Conscious sedation and vertebroplasty
Official scientific title Safety and efficacy of propofol and remifentanyl vs meperdine and midazolam as a conscious sedation in percutenous vertebroplasty :prospective randomized study
Brief summary describing the background and objectives of the trial comparison between different drugs used in conscious sedation to detect its efficacy and safety in percutenous vertebroplasty procedure
Type of trial RCT
Acronym (If the trial has an acronym then please provide) conscious sedation a
Disease(s) or condition(s) being studied Anaesthesia,conscious sedation ,vertebroplasty,Musculoskeletal Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 20/12/2017
Actual trial start date 28/12/2017
Anticipated date of last follow up 20/06/2018
Actual Last follow-up date 20/06/2018
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 60
Recruitment status Not yet recruiting
Publication URL conscious sedation and vertebroplasty
Secondary Ids Issuing authority/Trial register
31961/12/17 ethics committees 31961/12/17 ethics committees
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 Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group conscious sedation in percutenous vertebroplasty propofol bolus of 0.3 mg/kg followed by infusion at a rate of 0.3 mg/kg/h and increased by 0.1 mg/kg/h to a maximum of 0.5 mg/kg/h and a remifentanil bolus of 1 µg/kg over 30 seconds followed by infus through out the procedure conscious sedation in percutenous vertebroplasty 30
Experimental Group conscious sedation in percutenous vertebroplasty Initial intravenous doses of meperidine at 50¿75 mg and initial midazolam at 2¿3 mg were given. Additional doses were titrated based on bispecteral index reading . Increments of meperidine (25¿50 mg) through out the procedure conscious sedation in percutenous vertebroplasty 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Sixty patients American Society of Anesthesiologists (ASA) Grade I and II aged from 18 to 65 years of either sex undergoing percutaneous vertebroplasty for vertebral compression fractures, metastatic fractures of the spine Patients with known allergies to any drug used in the study patients with a pregnancy patients on sustained release narcotics and substance abuse patients not giving consent 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 20/12/2017 committee of Tanta university
Ethics Committee Address
Street address City Postal code Country
El-Geish Street Tanta 31257 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome time to reach conscious sedation level with induction at start of procedure
Primary Outcome time to recovery from conscious sedation at end of procedure until regain conscious level
Primary Outcome hemodynamic stability during procedure through out the procedure
Secondary Outcome side effects (nausea and vomiting ) after end of procedure
Secondary Outcome patients and surgeons satisfaction score after complete the procedure
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Tanta university hospital El-Geish Street Tanta 31257 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Tanta university El-Geish Street Tanta 31257 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Asmaa Fawzy Amer Mohamed Faried street Tanta Tanta 31257 Egypt University
Secondary Sponsor Eman Ramadan Salama El-Geish Street Tanta 31257 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Asmaa Fawzy Amer Mohamed Faried street Tanta Tanta 31257 Egypt
Eman Ramadan Salama El-Geish Street Tanta 31257 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Asmaa Amer asmaafawzyamer@yahoo.com 01225865765 Mohamed Faried street
City Postal code Country Position/Affiliation
Tanta 31512 Egypt lecturer
Role Name Email Phone Street address
Public Enquiries Eman Salama dr.ers1975@yahoo.com 01225865765 El-Geish Street
City Postal code Country Position/Affiliation
Tanta 31512 Egypt lecture
Role Name Email Phone Street address
Scientific Enquiries Asmaa Amer asmaafawzyamer@yahoo.com 01225865765 Mohamed Faried street
City Postal code Country Position/Affiliation
Tanta 31512 Egypt lecturer
REPORTING
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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