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.: PACTR202009875831645 Date of Approval: 17/09/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Prevention of Post Operative Sore Throat: Comparing Intravenous Lidocaine, Intra-Cuff Alkalinized Lidocaine and Placebo. A Randomized Controlled Trial.
Official scientific title Prevention of Post Operative Sore Throat: Comparing Intravenous Lidocaine, Intra-Cuff Alkalinized Lidocaine and Placebo. A Randomized Controlled Trial.
Brief summary describing the background and objectives of the trial Sore throat is frequent after general anesthesia with endotracheal intubation. Multiple techniques using lidocaine prevent them. We compare in this trial two different techniques versus a placebo. we aim to prove the efficacity of these methods and the superiority of a technique over the other.
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 Prevention
Anticipated trial start date 26/05/2019
Actual trial start date 26/05/2019
Anticipated date of last follow up 31/07/2019
Actual Last follow-up date 31/07/2019
Anticipated target sample size (number of participants) 90
Actual target sample size (number of participants) 97
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 a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Group T 30 patients operative time of 240 minutes maximum. 30 patients received saline for both intravenous bolus and cuff filling. 30 Placebo
Experimental Group Group S 30 patients operative time of 240 minutes maximum 30 patients received 1,5 mg.kg-1 lidocaine intravenous bolus. The cuff was filled with a minimal volume of saline for no air leak. 30
Experimental Group Group L 30 patients operative time of 240 minutes maximum. 30 patients received intravenous saline. The cuff was filled with a minimal volume for no air leak made of 4mg/ml of lidocaine and 0,42mg/ml of sodium bicarbonate. 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- Age above 18 years old. - Patients receiving elective visceral, urologic, orthopedic or plastic surgeries. - American Society Of Anesthesiologists (ASA) score of 1, 2 or 3. - Easy predicted intubation. - Intubation time estimated equal or less than 240 minutes. - Patient’s refusal. - Rapid sequence induction (RSI) - Predicted airway management difficulty. - Patient’s history of recent airway inflammation, injury or tumor. - Contraindication for the use of drugs necessary for the protocol. - ASA score of more than 3. - Intubation time estimated more than 240 minutes. - Use of supra-glottic tools for airway management. - Laparoscopic surgery. - Intubation time more than 240 minutes. - Airway management difficulty. - Traumatic airway management. - Accidental extubation. - Per-operative or recent re-intubation. - Broncho / laryngospasm. - Per-operative anaphylactic or allergic reaction. - Use of corticosteroids. - Anesthetic-protocol modifications. 80 and over: 80+ Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 19 Year(s) 100 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 25/05/2019 CNEM
Ethics Committee Address
Street address City Postal code Country
Institut Pasteur de Tunis , 1002 TUNIS BELVEDERE Tunis 1002 Tunisia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome We evaluated the incidence of sore throat at the sixth then twenty-fourth post-operative hour as a primary outcome. Patients had to answer to a “YES” or “NO” question: “do you feel having a sore throat?”. Throat pain was quantified using the Visual Analogic Scale (VAS): VAS had to be above 10 out of 100 to confirm a “Yes” answer. 6th then 24th post operative hour
Secondary Outcome Hemodynamic variations during orotracheal intubation and extubation: orotracheal intubations time and extubations time.
Secondary Outcome The incidence of cough at orotracheal intubation and emergence of anesthesia. orotracheal intubation s time and extubation s time.
Secondary Outcome The incidence of cough at the 6th and 24th post-operative hours 6th then 24th post operative hour
Secondary Outcome The incidence of dysphonia at the 6th and 24th post-operative hours 6th then 24th post operative hour
Secondary Outcome The incidence of dysphagia at the 6th and 24th post-operative hours 6th then 24th post operative hour
Secondary Outcome The incidence of nausea and vomiting at the 6th and 24th post-operative hours 6th then 24th post operative hour
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Centre Hospitalo Universitaire Habib Bourguiba Sfax Rue Al Firdaws, Sfax 3029 Sfax 3029 Tunisia
FUNDING SOURCES
Name of source Street address City Postal code Country
Yassine Maktouf Teniour Sfax 3041 Tunisia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor CHU Habib bourguiba Sfax Rue Al Firdaws Sfax 3029 Tunisia Hospital
COLLABORATORS
Name Street address City Postal code Country
Pr. Abdelhamid Karoui Rue Al Firdaws Sfax 3029 Tunisia
Pr. Ag. Imen Zouche Rue Al Firdaws Sfax 3029 Tunisia
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Yassine Maktouf yassine.maktouf@gmail.com 0021629442333 Teniour
City Postal code Country Position/Affiliation
Sfax 3041 Tunisia Anesthesiology and Intensive Care Resident
Role Name Email Phone Street address
Public Enquiries Salma Ketata slayma@hotmail.com 0021696107594 Rue Al Firdaws
City Postal code Country Position/Affiliation
Sfax 3029 Tunisia Assistante Hospitalo Universitaire
Role Name Email Phone Street address
Scientific Enquiries Abdelhamid Karoui abdelhamid.karoui@gmail.com 0021658115763 Rue Al Firdaws
City Postal code Country Position/Affiliation
Sfax 3029 Tunisia Professeur Hospitalo Universitaire Chef de Service Anesthesie Reanimation Chirurgicale du CHU Habib Bourguiba Sfax
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol Beginning 3 months and ending 5 years following article publication Researchers who provide a methodologically sound proposal
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