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.: PACTR201810651874628 Date of Approval: 22/10/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title The Effect of Saline Flush after Rocoronium Bolus on the Proportion of Patients with Excellent Intubating Conditions in Adult Patients Undergoing Elective Surgery at AKUH-N
Official scientific title The Effect of Saline Flush after Rocoronium Bolus on the Proportion of Patients with Excellent Intubating Conditions in Adult Patients Undergoing Elective Surgery Under General Anaesthesia at AKUH-N
Brief summary describing the background and objectives of the trial Background:In emergency surgeries requiring endotracheal intubation, thetime to effect of neuromuscular blocking drugs is a crucial timein which patients have a high risk of hypoxia and pulmonary aspiration.Various strategies have been undertaken to shorten this time, including timing and priming techniques,dose changes and use of a flush following the muscle relaxant. All these methods had positive results but some are associated with side effects. The effectiveness of a muscle relaxant can either be assessed using train of four or intubating conditions on the Goldberg scale. In this study, I plan to investigatethe effects of a 20 ml saline bolus following intravenousrocuronium at 0.6 mg/kg on the proportions of patients with excellent intubating conditions at one minute. Methodology:forty patientswill be randomly allocated to the saline bolus group or control group. General anesthesia will be induced and maintained with remifentanil and propofol via target controlled infusion (TCI). Rocuronium 0.6 mg/kg intravenous (IV) will be administered followed by 20 ml saline bolus in the study group compared to administration of 0.6 mg/kg rocuronium without a saline bolus in the control group. Intubation conditions will be assessed using the Goldberg scale filled by the intubating doctor. Onset of neuromuscular block will be assessed by acceleromyography at the adductor pollicis muscle with train-of-four monitor in which twitch height will be measured every 10 seconds.
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 Education /Training
Anticipated trial start date 03/12/2018
Actual trial start date
Anticipated date of last follow up 07/01/2019
Actual Last follow-up date
Anticipated target sample size (number of participants) 50
Actual target sample size (number of participants)
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization 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 saline flush 20mls 20 mls of normal saline flush following a dose of 0.6 mg/kg rocuronium flush given over 10 seconds the outcome of interest measured at one minute following the administration General anesthesia will be induced and maintained with remifentanil and propofol via target controlled infusion (TCI). Rocuronium 0.6 mg/kg intravenous (IV) will be administered followed by 20 ml saline bolus in this study group . Intubation conditions will be assessed using the Goldberg scale filled by the intubating doctor. Onset of neuromuscular block will be assessed by acceleromyography at the adductor pollicis muscle with train-of-four monitor in which twitch height will be measured every 10 seconds from time of administration to intubation 25
Control Group no saline flush group no saline flush following rocuronium 0.6mg/kg administration none General anesthesia will be induced and maintained with remifentanil and propofol via target controlled infusion (TCI). Rocuronium 0.6 mg/kg intravenous (IV) will be administered and no flush afterwards. Intubation conditions will be assessed using the Goldberg scale filled by the intubating doctor. Onset of neuromuscular block will be assessed by acceleromyography at the adductor pollicis muscle with train-of-four monitor in which twitch height will be measured every 10 seconds 25 Historical
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients will be between 18-65 years scheduled for non-emergent surgery under general anaesthesia requiring endotracheal intubation. All patients fitting the inclusion criteria will be required to give voluntary and informed consent to be eligible to participate in the study. Patients whowill decline consent to participate in the study. Patients known to have an allergy to rocuronium or any other of the study drugs. Patients scheduled for emergency surgery. Patients known to have a difficult airway (from previous anaesthetic notes or history) or suspected to have a difficult airway (including a body mass index (BMI) above 35kg/m2) during the anaesthesia review. Patients with heart failure or chronic liver disease and pregnant patients will be excluded from the study Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 65 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 09/11/2018 the aga khan university reseach ethics committee
Ethics Committee Address
Street address City Postal code Country
30270 nairobi 00100 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Proportion of patients with excellent intubating conditions at one minute assessed by the Goldberg scale measured at one minute following rocuronium and flush administration
Secondary Outcome The effect of saline flush after 0.6 milligrams per kilogram intravenous Rocuronium on the onset time of Rocuronium immediately after rocuronium administration, the onset time will be measured using acceleromyography
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
AGA KHAN UNIVERSITY HOSPITAL NAIROBI off third parklands road nairobi 00100 Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
aga khan university 30270 nairobi 00100 Kenya
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor AGA KHAN UNIVERSITY 30270 nairobi 00100 Kenya University
COLLABORATORS
Name Street address City Postal code Country
david odaba 30270 nairobi 00100 Kenya
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator ian odari ian.odari@aku.edu +254712568585 30270
City Postal code Country Position/Affiliation
nairobi 00100 Kenya resident doctor department of anaesthesiology
Role Name Email Phone Street address
Scientific Enquiries vitalis mungayi vitalis.mungayi@aku.edu +254733635554 30270
City Postal code Country Position/Affiliation
nairobi 00100 Kenya professor of anaesthesia
Role Name Email Phone Street address
Scientific Enquiries david odaba david.odaba@aku.edu +254717563461 30270
City Postal code Country Position/Affiliation
nairobi 00100 Kenya senior instructor
Role Name Email Phone Street address
Public Enquiries ian odari ian.odari@aku.edu +254712568585 30270
City Postal code Country Position/Affiliation
nairobi 00100 Kenya resident doctor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
No
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