is neuromuscular monitoring mandatory before extubation

Phase 2

Recruiting

Conditions: undergoing general anesthesia with endotracheal intubation with controlled ventilation

Registration Number: CTRI/2018/02/011887

Lead Sponsor: mahatma gandhi medical college and research institute

Brief Summary: Neuromuscularblocking agents are used to improve conditions for tracheal intubation, toprovide immobility during surgery, and to facilitate mechanical ventilation.It isalso essential to make sure that the effects of neuromuscular blocking drugshave worn off or are reversed before the patient is shifted to post anaestheticcare unit(PACU). Withintermediate acting agents, the incidence of residual paralysis remains highwith an overall 16% incidence has been reported without neuromuscularmonitoring compared to 3% in AMG monitored patients.(1)Thethreshold for complete neuromuscular recovery is a train-of-four ratio of 0.9,instead of the traditional 0.7. Recentstudies have demonstrated that low dose neostigmine 20mcg/kgis adequate to reverse the shallow neuromuscular blocking effects (TOFR 0.4)of vecuoronium (2), atracurium (3), rocuronium and cisatracurium(4).When neostigmine40mcg/kg was given to reverse shallowneuromuscular blockade produced by vecuronium they observed a drop in train of four ratio(TOFR) in the recoveryperiod.(2) Anticholinesterases, if given when neuromuscular block is absent,may produce evidence of neuromuscular dysfunction. In day today practise routine neuromuscular monitoring is not done and standard dose of neostigmine (40- 60Âµg/kg )is given as reversal when patient hasspontaneous attempts of breathing as a clinical sign of early stage of recoveryfrom neuromuscular blocking effects.We liketo observe and correlate the clinical signs of neuromuscular recovery withneuromuscular monitoring (TOF). (spontaneous breathing during reversal) and (sustained head lift for5secs during extubation ) and(respiratory rate in early postoperative period ).ASA I and II patients, with age 18-60 years and undergoing elective procedureunder general anaesthesia withendotracheal intubation and controlled ventilation will be enrolled in the study. Patients having neuromuscular disorder, hepatic or renal dysfunction, Difficult airway and Patients who are under medications thatinfluences the action of neuromuscular blockade are excluded from the study. After obtaining ethical committee approval, surgical patients posted for surgery under general anaesthesia with endotracheal tube intubation and controlled ventilation will be recruited for the study. Pre-anesthetic check will be done and the patients those satisfying the inclusion and exclusion criteria will be enrolled in the study by continuous sampling. written informed consent will be obtained . patients will be kept nil per oral for 8hours. patients will be premedicated with tab. ranitidine 150mg and tab. alprazolam 0.25mg night before and morning of surgery. After transferring the patient into the operation room monitors ( electrocardiogram(ECG), noninvaive bloodpressure(NIBP), pulseoximeter(SPO2) will be connected and baseline readings will be noted. .Intravenous cannulation will be done with a 18 G cannula and Ringer Lactate infusion will be started . Surface electrodes will be placed over the course of the ulnar nerve , just proximal to the wrist crease and neuromuscular monitor will be connected. premedication with inj. morphine (0.1mg/kg ),inj.midazolam 1mgwill be done .TOF stimulation will be given with 5 MA current and response will be assessed. Patient will be preoxygenated with 100% oxygen for three minutes and induced with Propofol(2-3mg/kg). At this stage Acceleromyography will be calibrated using the preprogrammed TOF-Watch calibration mode applying supramaximal stimulation current. Supramaximal current is the current above which there is no significant increase in electromyographic amplitude. When the TOF-Watch is switched on, it automatically sets the current to 60mA and amplitude to 100%. The current is then reduced in decrements of 5 mA till response of â‰¤ 90% is reached. Then 10% will be added to next higher value and this current is taken as supramaximal current. After stable base line recording of the TOF response, vecuronium bromide 0.1mg/kg IV will be administered to facilitate tracheal intubation. During surgery, vecuronium bromide bolus doses will be given to maintain TOF count 2. Anaesthesia was maintained with 40% oxygen in nitrous oxide (600ml total flow) along with Isoflurane to maintain a MAC of 1. End tidal concentration of CO2 to be maintained between 32 and 36 mmHg and central body temperature between 35-37 degree celsius throughout the surgical procedure. Ten minutes before expected time of end of surgery isoflurane will be stopped . Once the patient starts to breath spontaneously TOF will be monitored and when patient has regular breathing TOF will be assessed and they will be given reversal with glycopyrrolate 0.01mg/kg and neostigmine 50mcg/kg. Patient will be extubated after thorough oral suctioning and TOFR will be monitored and monitoring will be done every 10 minutes for one hour in the post operative period.

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: All

Target Recruitment: 100

Inclusion Criteria

ASA I ,and II patients Age 15-70 years Patients undergoing elective procedure under general anaesthesia with endotracheal intubation and controlled ventilation.

Exclusion Criteria

Patients having neuromuscular disorder, hepatic or renal dysfunction, Difficult airway Patients who are under medications that influences the action of neuromuscular blockade.

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
TOF monitoring will be done during reversal administration,extubation and 15 minutes interval in post operative period	TOF monitoring will be done during reversal administration,extubation and 15 minutes interval in post operative period

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (1): Mahatma Gandhi Medical College and Research Institute
🇮🇳
Pondicherry, PONDICHERRY, India
Mahatma Gandhi Medical College and Research Institute
🇮🇳Pondicherry, PONDICHERRY, India
DrRani P
Principal investigator
9443116908
anaesrani@gmail.com