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.: PACTR202005777730971 Date of Registration: 29/05/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Efficacy of combined thoracic paravertebral block and intravenous dexmedetomidine in medical thoracoscopy
Official scientific title Efficacy of combined thoracic paravertebral block and intravenous dexmedetomidine in medical thoracoscopy
Brief summary describing the background and objectives of the trial Thoracic Paravertebral block (TPVB) is instillation of local anaesthetic drug in the thoracic paravertebral space and can be used in several procedures such as medical thoracoscopy, VATS, lobectomy, pneumonectomy, etc. Also, insertion of a catheter in the paravertebral space for continuous intra and postoperative analgesia can be done. Dexmedetomidine is a potent α-2 agonist with a higher potency and short duration of action. The relatively short distribution half-life of approximately 6 minutes of dexmedetomidine results in rapid onset of sedation, and an elimination half-life of approximately 2 hours facilitates clearance of the drug. It Produces an ‘‘interactive’’ form of sedation, in which patients may be aroused easily with stimulation, and are cooperative once aroused. Moreover, it has analgesic properties, does not induce respiratory depression at clinically relevant doses and has predictable sympatholytic effects. Hence, this study was conducted to evaluate the efficacy of paravertebral block with intravenous infusion of dexmedtomidine compared to local anaesthesia using midazolam.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Circulatory System,Respiratory
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Thoracic paravertebral block and IV dexmedetomidine
Anticipated trial start date 01/04/2020
Actual trial start date
Anticipated date of last follow up 30/06/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants)
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
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group General anaesthesia 30 min General anaesthesia with IV deprivan 2 mg/kg, fentanyl 2 µg/kg, cisatracurium 0.1 mg/kg and xylocaine 1.5 mg/kg, group. Maintenance with isoflurane MAC 1.2% with endotracheal tube insertion. 30 Active-Treatment of Control Group
Experimental Group Thoracic paravertebral block and IV dexmedetomidine 30 min Paravertebral block at the level of medical thoracotomy covering three levels; at, above and below thoracotomy level, using a mixture of xylocaine 0.1% and marcaine 0.25% plus a loading dose of IV dexmedetomidine of 1 µg/kg over 10 min. then maintenance with 0.3 µg/kg all over the procedure in a non-intubated patient with nasal cannula oxygen flow 2 L/min. 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients indicated for medical thoracoscopy ASA I and II Aged 25-55 years No history of allergy to any of the used drugs. ASA III and IV Aged below 25 or above 55 years History of allergy to any of the used drugs. Uncooperative patient Severe musculoskeletal abnormalities Patients with coagulopathy Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 25 Year(s) 55 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 20/02/2020 Ethics Commitee Faculty of Medicine Alexandria University IRB No 00012098 FWA No 00018699
Ethics Committee Address
Street address City Postal code Country
17 Champlion street El Messalah Alexandria 21131 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Patient rated procedural pain on Visual Analogue Scale Immediately at the end of procedure
Secondary Outcome Heart rate (beats/min), mean arterial blood pressure (mmHg) and SpO2%. Preoperative,after thoracotomy and immediate postoperative
Secondary Outcome Operator rated overall procedure satisfaction (quality of the image, ease of maneuvering, ease of obtaining a biopsy sample, and the expectation that the biopsy sample will reveal a definitive histological diagnosis) on the visual analog scale from 0 to 100. At the end of the procedure
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Department of Chest Diseases at Alexandria Main University Hospital Champlion street, Azarita Alexandria Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Ayman Mohamed Maaly Champlion street, Azarita Alexandria Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Ayman Maaly Champlion street, Azarita Alexandria Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
Rehab Abdelrouf Champlion street, Azarita Alexandria Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ayman Mohamed Maaly aymanmaaly@gmail.com +201002258463 Champlion street, Azarita
City Postal code Country Position/Affiliation
Alexandria Egypt Lecturer of Anaesthesia and Surgical Intensive Care
Role Name Email Phone Street address
Public Enquiries Ahmed Abdelhady drahmedhady@gmail.com +201227896890 Champlion street, Azarita
City Postal code Country Position/Affiliation
Alexandria Egypt Lecturer of Chest diseases Faculty of Medicine Alexandria University
Role Name Email Phone Street address
Scientific Enquiries Rehab Abdelrouf trcium2002@yahoo.com +201001073703 Champlion street, Azarita
City Postal code Country Position/Affiliation
Alexandria Egypt Lecturer of Anaesthesia and surgical ICU Faculty of Medicine Alexandria University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Excel sheet of data of the patients Informed Consent Form,Study Protocol At about the end of 2020 (within one year). Data will be available on request by researchers interested in the study.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
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