A RANDOMIZED CONTROL TRIAL COMPARING TRAIN OF FOUR RATIO ¿0.9 TO CLINICAL ASSESSMENT OF RETURN OF NEUROMUSCULAR FUNCTION BEFORE ENDOTRACHEAL EXTUBATI

• Register: PACTR
• Last refreshed on: 29 May 2023
• Main ID: PACTR201501001021110
• Date of registration: 30/01/2015
• Prospective Registration: No
• Primary sponsor: The Aga Khan University Nairobi
• Public title: A RANDOMIZED CONTROL TRIAL COMPARING TRAIN OF FOUR RATIO ¿0.9 TO CLINICAL ASSESSMENT OF RETURN OF NEUROMUSCULAR FUNCTION BEFORE ENDOTRACHEAL EXTUBATI
• 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.
• Date of first enrolment: 01/04/2014
• Target sample size: 168
• Recruitment status: Complete
• URL: https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=1021
• Study type: Interventional
• Study design: 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.
• Phase: Not Applicable

Countries of recruitment

Kenya

Contacts

• Name: Vitalis Mungayi
• Affiliation: Faculty, The Aga Khan University Nairobi

• Name: Joan Irungu
• Affiliation: Programme Administrator, Department of Anaesthesia Aga Khan University Nairobi

Key inclusion & exclusion criteria

Inclusion criteria: Adults aged 18-65 years old, American society of anaesthesiology (ASA) physical status I and II undergoing elective surgery under general anaesthesia using cisatracurium.
Exclusion criteria: 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


Age minimum: 18 Year(s)
Age maximum: 65 Year(s)
Gender: Both

Health Condition(s) or Problem(s) studied

Critical respiratory events in post anaesthesia care unit

Respiratory
Critical respiratory events in post anaesthesia care unit

Respiratory

Intervention(s)

TOF ratio group

Clinical assessment group

Primary Outcome(s)

Whether using train of four ( TOF) ratio ¿0.9 before extubation reduces incidence of critical respiratory events (hypoxemia and upper airway obstruction) in PACU

Secondary Outcome(s)

Incidence of hypoxemia and upper airway in PACU

Secondary ID(s)

2014/REC-06

Source(s) of Monetary Support

The Aga Khan University Nairobi

Ethics review

Status: Approved
Approval date: 21/05/2014
Contact:

The Aga Khan University Nairobi Health research ethics committee