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.: PACTR202210590810112 Date of Approval: 28/10/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Dexamethasone nebulization versus ketamine nebulization in reducing complications of nasogastric tube .
Official scientific title Role of preoperative dexamethasone nebulization versus preoperative ketamine nebulization in reducing complications of nasogastric tube after laparoscopic surgery.
Brief summary describing the background and objectives of the trial This work aims to evaluate the efficacy of nebulized dexamethasone versus nebulized ketamine in alleviating post operative sore throat after inserting nasogastric tube in laparoscopic surgery. The primary outcome is the incidence of postoperative sore throat for 24 hours following surgery.The secondary outcome is assessment the rate of odynophagia, hoarseness of voice, and postoperative nausea and vomiting.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Ear, Nose and Throat,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 14/06/2021
Actual trial start date 14/06/2021
Anticipated date of last follow up 30/12/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 108
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 a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group saline group 5 ml normal saline nebulization apply once saline group was accepted as control group, applied once administered to patients via a nebulization mask connected to awall- mounted oxygen driven source (8 L per minute) for 15 minutes before induction of anaesthesia.The rate of post operative sore throat was evaluated, other group were evaluated according to this group. 36 Placebo
Experimental Group Dexamethasone group 8 mg dexamethasone by nebulization apply once dexamethasone group applied nebulized dexamethasone,administered to patients via a nebulization mask connected to awall- mounted oxygen driven source (8 L per minute) for 15 minutes before induction of anaesthesia, this group compared with the control group .The rate of post operative sore throat was evaluated, compared with other groups . 36
Experimental Group ketamine group 50 mg ketamine by nbulization apply once Ketamine group applied nebulized ketamine ,administered to patients via a nebulization mask connected to awall- mounted oxygen driven source (8 L per minute) for 15 minutes before induction of anaesthesia. This group compared with the control group .The rate of post operative sore throat was evaluated, compared with other groups . 36
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• Patients belonging to American Society of Anesthesiologists physical status I-II. • Age group (≥ 20-≤60 years). • Both sexes. • American Society of Anesthesiology (ASA) physical status ≥ III. • Age less than 20 and more than 60 years. • Known allergy or hypersensitivity to dexamthasone or ketamine. • Difficult intubation (Mallampati> III) or multiple trials of intubation. • Duration of operation less than 30 minutes. • Suction more than once under vision. • Heavy smokers (20 packs /week). • Pre-existing sore throat or respiratory tract infection within 2 weeks. • Patients with oesophageal pathologies. • Patients with history of laryngeal or pharyngeal surgery. • Patients on long administration of steroids. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 20 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 20/10/2022 Ain Shams University Faculty of medicine Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Abbasiya, Ramsis street cairo 11566 Egypt
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 13/06/2021 Ain Shams University Faculty of medicine Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Abbasiya , Ramsis street cairo 11566 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome incidence and severity of postoperative sore throat after surgery at recovery then 2 8 12 24 hours postoperative
Secondary Outcome the incidence of odynophagia, hoarseness of voice, and postoperative nausea and vomiting after surgery. At recovery from surgery within 30 minutes
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Faculty of medicine Abbasiya , Ramsis street cairo 11566 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Mai Mohammed Nasr city cairo 11566 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Ain Shams University Faculty of medicine Abbasiya , Ramsis street cairo 11566 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Prof. Dr. Sahar Mohammed Kamal hassanein Abbasiya cairo 11566 Egypt
Dr. Tarek Samir Shabana Abbasiya, Ramsis street cairo 11566 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mai Mohammed Zakaria mai_zakaria256@yahoo.com 00201112071838 Nasr city
City Postal code Country Position/Affiliation
cairo 11566 Egypt Assistant lecturer of anaesthesia and intensive care faculty of medicine Ain Shams University
Role Name Email Phone Street address
Scientific Enquiries Tarek Samir Shabana Tarek.shabana@hotmail.com 00201112071838 Abbasiya
City Postal code Country Position/Affiliation
cairo 11566 Egypt lecturer of anaesthesia and intensive care faculty of medicine Ain Shams University
Role Name Email Phone Street address
Public Enquiries Ayatallah Hosny Kamal Ayottoo@hotmail.com 00201112071838 Abbasiya
City Postal code Country Position/Affiliation
cairo 11566 Egypt assistant lecturer of anaesthesia and intensive care faculty of medicine Ain Shams University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes all of the individual participant data collected during the trial, after deidentification Study Protocol not applicaple not applicaple
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