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.: PACTR202302722474325 Date of Approval: 22/02/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Conscious sedation in bronchoscopy: A randomized controlled trial of the military hospital of Tunis
Official scientific title Conscious sedation in bronchoscopy: A randomized controlled trial of the military hospital of Tunis
Brief summary describing the background and objectives of the trial Bronchoscopy is an examination that is often anxiogenic, coughing, felt by the patient as unpleasant and sometimes painful. An optimal bronchoscopy carried outsafely and effectively, requires the comfort of both the patient and the interventionist physician. Thus, a proper anesthesia is of great interest. Multiple studies have been conducted on sedation ranging from local anesthesia to general anesthesiawith the goal of reducing patient discomfort and facilitating care. Local anesthesia does not effectively and optimally relieve the patient pain and anxiety. Persistent uncontrolled cough response decreases the reproducibility of the examination. General anesthesia offers total comfort. Disadvantages include high cost, long duration, need for a nearby operating room, an available anesthesiologist, and the risk of unpredictable life-threatening complications.Between these two approaches, conscious sedation finds a middle ground. Increasingly, conscious sedation is being adopted by interventional pulmonologists, with midazolam as the most used drug. According to the "British Thoracic Society" guidelines published in 2013, intravenous sedation is systematic for all bronchoscopy in the absence of contraindications. In Tunisia, the conscious sedation is, to this day, the field of anesthetists. In pneumology departments, bronchoscopy under local anesthesia is still performed. Conscious sedation was considered a difficult modality to integrate into everyday medical practice due to the risks associated with handling anesthetics without adequate training in resuscitation. The aim of the study was to determine the contribution of conscious sedation in bronchoscopy compared to local anesthesia in terms of patient comfort and safety.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/01/2022
Actual trial start date 03/04/2022
Anticipated date of last follow up 31/12/2022
Actual Last follow-up date 15/12/2022
Anticipated target sample size (number of participants) 80
Actual target sample size (number of participants) 93
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 randomization using by using procedures such as coin-tossing or dice-rolling Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Midazolam Midazolam, maximum dose: 0.05mg/kg, by bolus of 1mg every 5 min (not to exceed 5 mg), by IV injection (through a peripheral venous line). Dilution: 1 ampoule of midazolam (1cc) in 4cc of isotonic saline solution [1cc=1mg]. duration of the bronchoscopy The study consisted of the use of midazolam for sedation during bronchoscopy performed for a specific indication according to the following steps: 1) Midazolam, maximum dose: 0.05mg/kg, by bolus of 1mg every 5 min (not to exceed 5 mg), by IV injection (through a peripheral venous line). 2) Per physician trained in resuscitation and dedicated to sedation. 3) Two assistants, including one person with a nursing diploma, who assisted the physician performing the examination, to ensure safety in case of problems during the examination. 4) Resuscitation equipment must be available. 5) Flumazenil (Anexate) nearby (to be used in case of severe depression of the central nervous system with respect to its contraindications) 6) An isotonic saline solution nearby. 7) Patient scoped with monitoring of vital parameters (SpO2, Blood pressure, Pulse...). 8) MOASS score noted every 5 min (appendix 3). 9) Dose and time of midazolam injection noted with maximum dose respected and total dose administered noted. 10) Intra- and post-procedural monitoring written down and traced (patient scoped). 11) Discharge criteria from the interventional room identical to those of the recovery room (MOASS score>=5, oxygen weaning...) with a 3-hour monitoring. 12) Post-procedure advice identical to the ambulatory GA: No driving, not be alone andno activity with responsibility (childcare, elderly, important appointments...)in the 12 hours that follow, 13) The duration, the end-time of the bronchoscopy and thedischarge-time noted. 46
Control Group Placebo Isotonic saline solution every 5 min, by IV injection (through a peripheral venous line). During the bronchoscopy Isotonic saline solution Resuscitation equipment must be available. An isotonic saline solution nearby. Patient scoped with monitoring of vital parameters (SpO2, Blood pressure, Pulse...). Intra- and post-procedural monitoring written down and traced (patient scoped). The duration, the end-time of the bronchoscopy and the discharge-time noted. 47 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- The right indication for bronchoscopy was established. - Samples (biopsies, bronchoalveolar washing, ...) scheduled beforehand. - Patient record available. - Verification of the management of anticoagulant and antiaggregant drugs. - Patients informed of sedation having given their free consent. - Patients informed of the following precautions: Be accompanied within the 12 hoursafter the procedure. Do not drive for 12 hours after the procedure. No responsible activity within the 12 hoursafter the procedure. o Lost to follow-up o Unreachable by telephone o Uncooperative o Psychologically unstable Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 80 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 28/03/2022 Local committee for the protection of individuals of the military hospital of Tunis
Ethics Committee Address
Street address City Postal code Country
Mont Fleury-1008 Tunis Tunis 1008 Tunisia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Conscious sedation with midazolam is a safe and easy procedure to perform to optimize patient comfort during bronchoscopy. All bronchoscopies performed under midazolam were significantly more comfortable than the ones performed under LA. December 2022
Secondary Outcome Conscious sedation with midazolam is a safe procedure to perform. All bronchoscopies performed under midazolam had no additional risk of complications, compared to the ones performed under LA. December 2022
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Military hospital of Tunis Mont Fleury-1008 Tunis Tunis 1008 Tunisia
FUNDING SOURCES
Name of source Street address City Postal code Country
the military hospital of tunis Mont Fleury- 1008 Tunis tunis 1008 Tunisia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Military hospital of Tunis Mont Fleury-1008 Tunis Tunis 1008 Tunisia Hospital
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Lenda Ben Hmida benhmidalenda@gmail.com 58087867 Mont Fleury-1008 Tunis
City Postal code Country Position/Affiliation
Tunis 1008 Tunisia Military hospital of Tunis
Role Name Email Phone Street address
Public Enquiries Islam Mejri islammejri@gmail.com 58162142 Mont Fleury-1008 Tunis
City Postal code Country Position/Affiliation
Tunis 1008 Tunisia Military hospital of Tunis
Role Name Email Phone Street address
Scientific Enquiries Islam Mejri islammejri@gmail.com 58162142 Mont Fleury-1008 Tunis
City Postal code Country Position/Affiliation
Tunis 1008 Tunisia Military hospital of Tunis
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Data obtained through this study may be provided to qualified researchers with academic interest in conscious sedation in bronchoscopy. Data or samples shared will be coded, with no PHI included. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party. Informed Consent Form,Study Protocol Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA).
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