Use of neuromuscular monitor to assess intubating conditions
- Conditions
- 18 to 60 yearseither sexASA I and II
- Registration Number
- CTRI/2016/10/007419
- Lead Sponsor
- Lady Hardinge Medical College
- Brief Summary
Neuromuscularblockers (NMBs) are widely used in anaesthesia practice during endotrachealintubation. The degree of neuromuscular block is usually evaluated by clinicalcriteria. But the recommendation for application of neuromuscular monitoring topatients receiving NMBs is based on two important issues: first, on thevariable individual response to muscle relaxants and second because of thenarrow therapeutic window. Adequate muscle relaxation for intubation corresponds to a narrow rangeof 90 to 95% receptor occupancy.1 Inadequate muscle relaxationduring intubation can lead to difficulty in securing the airway or multipleattempts leading to laryngeal morbidity like postoperative hoarseness (4-42%)and vocal cord injury.2
Rocuroniumis one of the most commonly used non depolarising muscle relaxant forintubation of the trachea. It has been postulated that laryngeal muscles beingresistant to the effects of neuromuscular blocking agents,3 requireat least twice the ED95 dose.4
Asit is difficult to quantify the relaxation of the laryngeal muscles, thereforesurrogates such as Adductor pollicis longus (APL), orbicularis oculi (OO),corrugator supercilii (CS)5 and even flexor hallucis brevis (FHB)6have been utilised, though APL is the preferred site. Neuromuscular transmissioncan be monitored by various methods like single twitch (ST), double burststimulation (DBS) and train of four (TOF). Although good clinical researchpractice (GCRP) states that either ST or TOF can be used as a guide forintubation, TOF is preferable because it is more sensitive to lesser degree ofreceptor occupancy than single twitch.1 Observation of evoked TOFresponses after a dose of non depolarising muscle relaxant allows prediction of onset time of paralysis oflaryngeal muscles in individualpatients.
Inthe absence of availability of NMT monitors, timed intubation has beenpracticed. However, patient factors1 such as age, gender,7medical condition (ASA physical status), body weight affect thepharmacokinetics and pharmacodynamics of the drug.
Onreviewing the literature, we found that although, clinically acceptableconditions have been obtained with rocuronium 0.6mg/kg in 90 seconds, therehave not been many studies to quantify the proportion of patients havingexcellent conditions and time required thereof for a standard observableendpoint i.e, disappearance of either three (T1) or all twitches (T0) after aTOF stimulus. The literature does not indicate which endpoint provides the bestintubating conditions.
Thereforethere is a need to ascertain the percentage of healthy routine patientsachieving excellent intubating conditions and the time taken to achieve thesewith rocuronium 0.6mg/Kg using defined monitor i.e, TOF stimulation and associatedpost operative sore throat if any.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 250
1.Age 18 to 60 yrs of either sex 2.ASA physical status I and II 3.Planned for elective surgery under general anaesthesia receiving rocuronium 0.6 mg/Kg for endotracheal intubation.
1.Patient refusal to participate in the study 2.Patients with history of neuromuscular disease 3.Patients having anticipated difficult airway 4.Patients with BMI <20 and >30 5.Patients unable to converse in Hindi or English.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number of patients having excellent intubating conditions with rocuronium 0.6mg/Kg After endotracheal intubation
- Secondary Outcome Measures
Name Time Method a)Mean time to achieve T1 or T0 b)Intubating conditions at T1 or T0
Trial Locations
- Locations (1)
Main Operation theatre
🇮🇳Delhi, DELHI, India
Main Operation theatre🇮🇳Delhi, DELHI, IndiaDr Deepa RaniPrincipal investigator8826599684deeparani10220@gmail.com