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.: PACTR202105778223198 Date of Approval: 19/05/2021
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title THE EFFECT OF SALINE FLUSH AFTER ROCURONIUM BOLUS ON THE PROPORTION OF PATIENTS WITH EXCELLENT INTUBATING CONDITIONS IN ADULT PATIENTS UNDERGOING ELECTIVE SURGERY AT AGA KHAN UNIVERSITY HOSPITAL NAIROBI
Official scientific title THE EFFECT OF SALINE FLUSH AFTER ROCURONIUM BOLUS ON THE PROPORTION OF PATIENTS WITH EXCELLENT INTUBATING CONDITIONS IN ADULT PATIENTS UNDERGOING ELECTIVE SURGERY AT AGA KHAN UNIVERSITY HOSPITAL NAIROBI
Brief summary describing the background and objectives of the trial In emergency surgeries requiring endotracheal intubation, the time to effect of neuromuscular blocking drugs is a crucial time in which patients are predisposed to hypoxia and aspiration into the lungs. Various strategies have been undertaken to shorten this time, including the timing and the 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 the train of four or intubating conditions on the Goldberg scale. In this study, the plan was to investigate the effects of a 20 ml saline bolus following intravenous rocuronium at 0.6 mg/kg on the proportions of patients with excellent intubating conditions at one minute.
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 10/11/2018
Actual trial start date 10/11/2018
Anticipated date of last follow up 09/11/2019
Actual Last follow-up date 09/11/2019
Anticipated target sample size (number of participants) 62
Actual target sample size (number of participants) 50
Recruitment status Completed
Publication URL N/A
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
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Rocuronium group 0.6 mg/kg rocuronium in 10 mls Pushed in intravenous fluid running at 300 mls/hour. 0.6 mg/kg rocuronium in 10 mls pushed as is the usual standard of care 25 Historical
Experimental Group Saline flush 20 mls saline Push after rocuronium administration Used to flush the rocuronium 0.6mg/kg after administration 25
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients between 18-65 years scheduled for non-emergent surgery under general anaesthesia requiring oral endotracheal intubation. Patients scheduled for surgery between 8 a.m. and 6 p.m. (This is the time when elective cases are scheduled in the study institution). Patients with ASA grade I to III. Patients whose anaesthetic technique included total intravenous anaesthesia (TIVA). • Patients who declined to consent to participation in the study. • Patients known to have an allergy to rocuronium or any other of the study drugs. • Patients scheduled for emergency surgery. • Patients with ASA category IV to VI. • Patients known to have a difficult airway (from previous anaesthetic notes or history) or suspected to have a difficult airway using the modified LEMON criteria score (including a body mass index (BMI) above 35kg/m2) during the anaesthesia review. • Patients who had non-emergency surgery scheduled between 6 p.m. and 8 a.m. • Patients with heart failure or chronic liver disease and pregnant patients were 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 Research Ethics Committee Aga Khan University
Ethics Committee Address
Street address City Postal code Country
3rd Parklands Avenue of Limuru Road, Nairobi Nairobi 00100 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome To determine the effect of a 20ml saline flush after 0.6 milligrams per kilogram intravenous Rocuronium on the proportion of patients with excellent intubating conditions at one minute assessed by the Goldberg scale in adult patients undergoing elective surgery under general anaesthesia at AKUH-N. One minute
Secondary Outcome To determine the relationship between intubating conditions and the twitch height at one minute following a saline flush with 0.6 milligrams per kilogram intravenous Rocuronium in patients having elective surgery under general anaesthesia with oral endotracheal intubation at AKUH-N. One minute
Secondary Outcome To determine the effect of saline flush after 0.6 milligrams per kilogram intravenous Rocuronium on the onset time of Rocuronium as measured by the degree of twitch height depression in adult patients undergoing elective surgery under general anaesthesia at AKUH-N. One minute
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Aga Khan University Hospital Nairobi 3rd Parklands Avenue off Limuru Road Nairobi. Nairobi 00100 Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
Aga Khan University Research Council 3rd Parklands Venue of Limuru Road Nairobi 00100 Kenya
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Aga Khan University Research Committee 3rd Parklands Avenue off Limuru Road Nairobi 00100 Kenya University
COLLABORATORS
Name Street address City Postal code Country
There is no collaborator in this study There is no collaborator in this study There is no collaborator in this study Kenya
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Vitalis Mungayi vitalis.mung'ayi@aku.edu +254724904010 3rd Parklands
City Postal code Country Position/Affiliation
Nairobi 00100 Kenya Fulltime Academic Faculty
Role Name Email Phone Street address
Public Enquiries Rajpreet Bal rajpreet.bal@aku.edu +254738496298 3rd Parklands Avenue off Limuru Road
City Postal code Country Position/Affiliation
Nairobi 00100 Kenya Fulltime Academic Faculty
Role Name Email Phone Street address
Scientific Enquiries Vitalis Mungayi vitalis.mung'ayi@aku.edu +254724904010 3rd Parklands Avenue off Limuru Road
City Postal code Country Position/Affiliation
Nairobi 00100 Kenya Fulltime Academic Faculty
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Abstract Study Protocol 12 months Journal article
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Pending Yes 31/03/2021 01/09/2021
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 31/03/2021
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information