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.: PACTR201501001021110 Date of Approval: 30/01/2015
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title A RANDOMIZED CONTROL TRIAL COMPARING TRAIN OF FOUR RATIO ¿0.9 TO CLINICAL ASSESSMENT OF RETURN OF NEUROMUSCULAR FUNCTION BEFORE ENDOTRACHEAL EXTUBATI
Official scientific title A RANDOMIZED CONTROL TRIAL COMPARING TRAIN OF FOUR RATIO ¿0.9 TO CLINICAL ASSESSMENT OF RETURN OF NEUROMUSCULAR FUNCTION BEFORE ENDOTRACHEAL EXTUBATION ON CRITICAL RESPIRATORY EVENTS IN ADULT PATIENTS UNDERGOING ELECTIVE SURGERY AT THE AGA KHAN UNIVERSITY HOSPITAL NAIROBI.
Brief summary describing the background and objectives of the trial There is increasing evidence that the incidence of postoperative residual curarisation after using neuromuscular blockers ranges from 24 to 50% in post anaesthesia care unit and is associated with postoperative complications such as critical respiratory events as evidenced with hypoxia, hypoventilation and upper airway obstruction. Quantitative neuromuscular monitoring and reversal of neuromuscular blockers has been shown to reduce postoperative residual curarisation. However, a recent meta-analysis by Naguib et al did not demonstrate a difference between quantitative neuromuscular monitoring and no monitoring on residual paresis. However, critics urge that this meta-analysis relied on cohort studies and confounding could have influenced the results. There are very few outcome studies on effect of residual paresis in Post anaesthesia care unit (PACU). No published randomised control trial has been done to show whether using Train of four (TOF) ratio ¿0.9 before endotracheal extubation compared to clinical assessment of return of neuromuscular function reduces the incidence of critical respiratory events in PACU. Primary Objective To determine whether using TOF ratio ¿0.9 or clinical assessment of return of neuromuscular function before endotracheal extubation reduces the incidence of critical respiratory events in PACU Secondary objectives To determine incidence and severity of hypoxia in PACU To determine incidence of upper airway obstruction in PACU
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Critical respiratory events in post anaesthesia care unit,Respiratory
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 01/04/2014
Actual trial start date 22/05/2014
Anticipated date of last follow up 31/10/2014
Actual Last follow-up date 30/11/2014
Anticipated target sample size (number of participants) 168
Actual target sample size (number of participants) 168
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
2014/REC-06 The Aga Khan University
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 Patients requiring general anaesthesia for elective surgery with cisatracurium as the muscle relaxant were randomised into 2 groups using computer generated numbers. Group 1 were patients who required a TOF ratio of ¿0.9 before extubation. Group 2 patients were extubated based on clinical assessment of return of neuromuscular function by the anaesthetist as is the standard of practice at the Aga Khan University hospital Nairobi. The numbers were sealed in envelopes and delivered to the anaesthetist administering general anaesthesia. Open-label(Masking Not Used) Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Clinical assessment group Patient required head lift for at least 5 seconds, good tidal volumes with a regular respiratory rate of at least 12 breaths or cannot tolerate the orotracheal tube, before being extubated and transferred to post anaesthesia care unit. 84 Active-Treatment of Control Group
Experimental Group TOF ratio group TOF ratio ¿0.9 2 surface electrodes was placed over the ulna nerve at the wrist after cleansing and rubbing the skin with an abrasive solution. The acceleration transducer was attached on the volar aspect of the distal phalanx of the thumb. Current selected was be 50mA for all the patients in this group (TOF watchR SX, Organon). This was done after the patient is under anaesthesia. 84
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Adults aged 18-65 years old, American society of anaesthesiology (ASA) physical status I and II undergoing elective surgery under general anaesthesia using cisatracurium. 1. ASA status III and above 2. Pregnant women 3. Patients with neuromuscular diseases 4. Patients on medications that interfere with neuromuscular junction function. For example, magnesium sulphate and aminoglycosides 5. Patients with renal, hepatic or respiratory diseases 6. Patient refusal 7. Patients with BMI >30 8. Patients allergic to cisatracurium 9. Patients undergoing brain surgery 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 21/05/2014 The Aga Khan University Nairobi Health research 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 Whether using train of four ( TOF) ratio ¿0.9 before extubation reduces incidence of critical respiratory events (hypoxemia and upper airway obstruction) in PACU On arrival in PACU and for the 30 minutes in PACU
Secondary Outcome Incidence of hypoxemia and upper airway in PACU On arrival in PACU and during first 30 minutes in PACU
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
The Aga Khan University Hospital Nairobi 30270 Nairobi 00100 Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
The Aga Khan University Nairobi 30270 Nairobi 00100 Kenya
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor The Aga Khan University Nairobi 30270 Nairobi 00100 Kenya University
COLLABORATORS
Name Street address City Postal code Country
The Aga Khan University Nairobi 30270 Nairobi 00100 Kenya
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Isaac Adembesa kadembesa@yahoo.com +254 720 949 430 30270
City Postal code Country Position/Affiliation
Nairobi 00100 Kenya Resident in the Department of Anaesthesia
Role Name Email Phone Street address
Public Enquiries Joan Irungu joan.irungu@aku.edu +254 732 277457 30270
City Postal code Country Position/Affiliation
Nairobi 00100 Kenya Programme Administrator, Department of Anaesthesia Aga Khan University Nairobi
Role Name Email Phone Street address
Scientific Enquiries Vitalis Mungayi mungayi.vitalis@aku.edu +254 724 904 010 30270
City Postal code Country Position/Affiliation
Nairobi 00100 Kenya Faculty, The Aga Khan University Nairobi
REPORTING
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