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CTRI Number  CTRI/2024/06/068399 [Registered on: 05/06/2024] Trial Registered Prospectively
Last Modified On: 27/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study to compare the effect of two medications (Neostigmine and Sugammadex) on breathing, after facial surgery by using ultrasonography to measure the function of respiratory muscle.  
Scientific Title of Study   Comparison of Effect of Neostigmine And Sugammadex On Post Operative Diaphragmatic Function assessed Ultrasonographically in Adult Patients Undergoing Oro-Maxillofacial Surgery: A Randomized Control Trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Swati Chhabra 
Designation  Additional Professor 
Affiliation  All India Institute of Medical Sciences Jodhpur 
Address  Department of Anaesthesiology and Critical Care Third floor Emergency block AIIMS Basni industrial area phase 2

Jodhpur
RAJASTHAN
342005
India 
Phone  07340033034  
Fax    
Email  swati_virgo83@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Swati Chhabra 
Designation  Additional Professor 
Affiliation  All India Institute of Medical Sciences Jodhpur 
Address  Department of Anaesthesiology and Critical Care Third floor Emergency block AIIMS Basni industrial area phase 2

Jodhpur
RAJASTHAN
342005
India 
Phone  07340033034  
Fax    
Email  swati_virgo83@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr Amrita Priya Nair 
Designation  Junior Resident 
Affiliation  All India Institute of Medical Sciences Jodhpur 
Address  Department of Anaesthesiology and Critical Care Third floor Emergency block AIIMS Basni industrial area phase 2

Jodhpur
RAJASTHAN
342005
India 
Phone  09446034581  
Fax    
Email  amritanair96@yahoo.com  
 
Source of Monetary or Material Support  
Department of Anaesthesiology and Critical Care, All India Institute of Medical Sciences Jodhpur, Basni phase 2, 342005  
 
Primary Sponsor  
Name  All India Institute of Medical Sciences Jodhpur 
Address  Basni industrial area phase 2 Jodhpur Rajasthan 342005  
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Swati Chhabra   All India Institute of Medical Sciences Jodhpur   Department of Anaesthesiology and Critical Care, Third floor Emergency Block
Jodhpur
RAJASTHAN 		 07340033034

swati_virgo83@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AIIMS, JODHPUR, Institutional Ethics committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Comparing the effect of Neostigmine and Sugammadex on the recovery of diaphragmatic muscle strength in the post extubation period using ultrasonography.   Preoperative ultrasonography will be done to measure diaphragmatic excursion, thickness fraction, and internal oblique thickness fraction. In the operation theatre, the patients will be monitored with a three-lead ECG, NIBP, and pulse oximetry. A standard Anaesthesia protocol for induction will be followed in all patients. After 3 minutes of preoxygenation with 100% oxygen, general anaesthesia will be induced with Fentanyl 2 mcg/kg , Propofol 2–3mg/kg, and Rocuronium 0.6-1.2 mg /kg. Maintenance with inhalation agent- Sevoflurane, maintaining a MAC of 1. Neuromuscular transmission monitoring (NMT) will be done in all patients to look for train of four (TOF). Either of the two study drugs will be given for reversal of neuromuscular blockade and ultrasonography will be done immediately in the postoperative period and after 30 minutes in PACU to measure the three parameters.  
Comparator Agent  Patients will be randomly assigned with a 1:1 ratio to the Neostigmine (A group) and Sugammadex (B group).   Randomisation will be done using computer generated random numbers for allocation of patients into two groups- A and B. The syringe will be prepared by a non-participating person who will know the body weight of the patient. Group A will be given Neostigmine at 50 mcg/kg dose when TOFR is 0.7. Group B will be given Sugammadex at 4 mg/kg dose when TOFR is 0.7. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Adults (18-65 years) undergoing elective oro-maxillofacial surgeries under general anaesthesia, receiving neuromuscular blockade. 
 
ExclusionCriteria 
Details  1.Patients denying consent to participate in the study.
2.Patients with lung disease- COPD, ILD.
3.Any condition in which diaphragm cannot be assessed using ultrasonography.
4.Patients with diaphragmatic hernia, ascites, stroke, pregnancy
5.Patients with suspected neuromuscular disease/ phrenic nerve injury.
6.Patients who require postoperative mechanical ventilation.
7.Patients with any contraindications or known allergy to Neostigmine or Sugammadex.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Comparison of the change in diaphragmatic excursion at baseline and after TOFR more than 0.9 with Neostigmine and Sugammadex as reversal agents for neuromuscular blockade.
 		 At baseline and at TOFR more than 0.9
 
 
Secondary Outcome  
Outcome  TimePoints 
Comparison of the change in diaphragmatic thickness fraction at baseline and after TOFR more than 0.9 with Neostigmine and Sugammadex as reversal agents for neuromuscular blockade.
 		 At baseline and at TOFR more than 0.9 
Comparison of the change in diaphragmatic excursion at baseline and after 30 minutes in PACU with Neostigmine and Sugammadex as reversal agents for neuromuscular blockade.  At baseline and after 30 minutes in PACU 
Comparison of the change in diaphragmatic thickness fraction at baseline and after 30 minutes in PACU with Neostigmine and Sugammadex as reversal agents for neuromuscular blockade.
 		 At baseline and after 30 minutes in PACU 
Comparison of the change in internal oblique thickness fraction at baseline and after TOFR more than 0.9 with Neostigmine and Sugammadex as reversal agents for neuromuscular blockade.
 		 At baseline and at TOFR more than 0.9 
Comparison of the change in internal oblique muscle thickness fraction at baseline and after 30 minutes in PACU with Neostigmine and Sugammadex as reversal agents for neuromuscular blockade.  At baseline and after 30 minutes in PACU 
Time taken to achieve a TOFR more than 0.9 after injecting Neostigmine and Sugammadex.
 		 From TOFR 0.7 to TOFR 0.9 
Any side effects of Neostigmine and Sugammadex.
 		 From TOFR 0.7 till 30 minutes after in PACU 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   10/06/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   Neuromuscular blocking agents are frequently administered in surgical settings. Ensuring effective reversal of neuromuscular blockade is crucial for the restoration of muscle function to its preoperative state, thus safeguarding patients against postoperative pulmonary complications. 
Patients will be randomly assigned with a 1:1 ratio to the Neostigmine (A group) and Sugammadex (B group). Preoperative assessment will be conducted in the preoperative area, one hour before surgery, using Ultrasound (GE Healthcare).  Diaphragmatic excursion and thickness fraction – indicative of inspiratory and expiratory muscle strength, will be measured while the patient is in a semi-recumbent position, with the head of the bed elevated to 45 degrees. The diaphragmatic excursion is evaluated through ultrasonography by placing the probe on the midclavicular line along the costal margin, angled over 70 degrees targeting the diaphragm dome (probe directed medially, cephalad, and dorsally) and then initiating M-mode tracing. Diaphragmatic excursion (DE) is the vertical thickness from the baseline to the highest inspiration point in quiet breathing. Diaphragm thickness is measured using a high frequency 10 MHz linear probe- B mode. Diaphragmatic Thickness fraction = Te insp - Te exp/ Te exp, where Te insp and Te exp are the thickness at the end of inspiration and expiration respectively. Internal oblique muscle thickness refers to the expiratory muscle strength. A linear probe will be placed midway between the costal margin and the iliac crest in the anterior axillary line with the probe perpendicular to the abdominal wall. Internal oblique muscle thickness is also measured at the end inspiration and also when the patient coughs with maximum strength.1

           TFIO =end coughing thickness-end inspiratory thickness / end inspiratory thickness X 100

All the above parameters will be measured 3 times each and the mean value will be considered   for data analysis.

In the operation theatre, the patients will be monitored with a three-lead ECG, NIBP, and pulse oximetry. A standard Anaesthesia protocol for induction will be followed in all patients. After 3 minutes of preoxygenation with 100% oxygen, general anaesthesia will be induced with Fentanyl 2 mcg/kg , Propofol 2–3mg/kg, and Rocuronium 0.6-1.2 mg /kg. Maintenance with inhalation agent- Sevoflurane, maintaining a MAC of 1. Neuromuscular transmission monitoring (NMT) will be done in all patients to look for train of four (TOF).

Reversal agent- either Neostigmine 50 mcg/kg or Sugammadex 4 mg/kg will be given when TOFR is 0.7. The patient will be assessed in the immediate post extubation period and 30 minutes post extubation in PACU, using ultrasonography in the same technique to measure diaphragmatic excursion, diaphragmatic thickness fraction and internal oblique thickness fraction. Both the preoperative and postoperative values will be compared and analysed for any residual effect of the neuromuscular blockade.

 
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