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CTRI Number  CTRI/2023/05/052678 [Registered on: 16/05/2023] Trial Registered Prospectively
Last Modified On: 28/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Other 
Public Title of Study   Comparison of Neostigmine versus Sugammadex after muscle paralysis by muscle relaxants by doing ultrasonography of diaphragm. 
Scientific Title of Study   Comparison of Neostigmine Vs. Sugammadex for recovery of muscle function after neuromuscular blockade by means of diaphragm ultrasonography in non-cardiac surgery: A randomised control trial  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Amlan Kusum Rout 
Designation  Junior resident( Academic) , Department- Anesthesiology and Critical care Medicine 
Affiliation  AIIMS, Bhubaneswar 
Address  Department of Anesthesiology and Critical Care Medicine, 5th floor , Room no. 8, faculty room ,Hospital block, AIIMS Bhubaneswar, Sijua, Patrapada, PO- Dumuduma, Bhubaneswar
Department of Anesthesiology and Critical Care Medicine, 4th floor , Room no. 409, Academic block, AIIMS Bhubaneswar, Sijua, Patrapada, PO- Dumuduma, Bhubaneswar
Khordha
ORISSA
751019
India 
Phone  8763437506  
Fax    
Email  kusumroutamlan@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prasanta Kumar Das 
Designation  Associate Professor, Department- Anesthesiology and Critical care Medicine 
Affiliation  AIIMS, Bhubaneswar 
Address  Department of Anesthesiology And Critical Care, 4th floor, room no-409,Academic block, AIIMS Bhubaneswar, Sijua, Patrapada, PO- Dumuduma, Bhubaneswar
Department of Anesthesiology And Critical Care, 4th floor, room no-409,Academic block, AIIMS Bhubaneswar, Sijua, Patrapada, PO- Dumuduma, Bhubaneswar
Khordha
ORISSA
751019
India 
Phone  9312677007  
Fax    
Email  docdas.aiims@gmail.com  
 
Details of Contact Person
Public Query  
Name  Amlan Kusum Rout 
Designation  Junior resident( Academic) , Department- Anesthesiology and Critical care Medicine 
Affiliation  AIIMS, Bhubaneswar 
Address  Department of Anesthesiology and Critical Care Medicine, 5th floor , faculty Room no. 8, Hospital block, AIIMS Bhubaneswar, Sijua, Patrapada, PO- Dumuduma, Bhubaneswar
Department of Anesthesiology And Critical Care, 4th floor, room no-409,Academic block, AIIMS Bhubaneswar, Sijua, Patrapada, PO- Dumuduma, Bhubaneswar
Khordha
ORISSA
751019
India 
Phone  8763437506  
Fax    
Email  kusumroutamlan@gmail.com  
 
Source of Monetary or Material Support  
AIIMS Bhubaneswar 
 
Primary Sponsor  
Name  Dr Prasanta Kumar Das 
Address  All India Institute of Medical Sciences, Bhubaneswar Sijua, Patrapada, PO- Dumuduma, Bhubaneswar, Odisha, Pincode- 756048 
Type of Sponsor  Other [self] 
 
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 Amlan Kusum Rout  AIIMS , Bhubaneswar  Department of Anesthesiology And Critical Care, in Preoperative area, inside Operation Theatre complex & Postoperative Area, ICU or respective wards of respective surgical unit after discharge from Postoperative area, AIIMS Bhubaneswar, Sijua, Patrapada, PO- Dumuduma, Bhubaneswar, Odisha, Pincode- 751019
Khordha
ORISSA 		 8763437506

kusumroutamlan@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
iNSTITUTIONAL ETHICS COMMITTEE, All India Institute of Medical Sciences, Bhubaneswar  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 
Comparator Agent  Neostigmine  Group B[ NEOSTIGMINE] will receive Neostigmine 50mcg/kg IV on appearance of three twitches in NMT( neuromuscular monitoring). it will be given ONCE for reversal of effects of neuromuscular blocking agents( muscle relaxants) used in general anesthesia. We will measure the thickening fraction of diaphragm by ultrasonography at three readings. The baseline will be taken before induction, just before extubation, at 30 minutes after extubation in postop area. We will compare the diaphragmatic thickening fraction and compare residual muscle paralysis of muscle relaxants used. 
Intervention  Sugammadex  Group A[ SUGAMMADEX] will receive Sugammadex 2mg/kg Intravenous on appearance of three twitches in NMT( neuromuscular monitoring) it will be given ONCE for reversal of effects of neuromuscular blocking agents ( muscle relaxants) used in general anesthesia. We will measure the thickening fraction of diaphragm by ultrasonography at three readings. The baseline will be taken before induction, just before extubation, at 30 minutes after extubation in postop area.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Patients undergoing elective non-cardiac
surgery
2. ASA grade I to III
3. AGE- 18- 70 Years
 
 
ExclusionCriteria 
Details  1. Emergency surgery
2. Refusal to treatment
3. Allergy to study drug
4. Renal and hepatic failure
5. Pregnant and nursing mother
6. Diaphragmatic palsy
7. Poor image quality
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the incidence of PORC defined by diaphragmatic thickening fraction ≤0.36 ,
between two groups after administration of Neostigmine or Sugammadex assessed by diaphragm USG
 		 We will measure the thickening fraction of diaphragm by ultrasonography at three readings. The baseline will be taken before induction, just before extubation, at 30 minutes after extubation in postop area.
All the outcomes will be assessed for 24 hours for taking the results into account.
 
 
Secondary Outcome  
Outcome  TimePoints 
To compare:

1)Time to achieve TOF ratio ≥ 0.9 or four twitches since administration of last dose of muscle relaxant (whichever is later)

2)Time to achieve TOF ratio ≥ 0.9 or four twitches after administration of reversal agent (whichever is later)

3)Postoperative pulmonary complications (PPC) within 24 hours [ PPC defined by SpO2 less than 90% or requiring oxygen therapy to maintain SpO2 more than 95% ]

3)Incidence of adverse effects
 		 within 24 hours 
 
Target Sample Size   Total Sample Size="76"
Sample Size from India="76" 
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   N/A 
Date of First Enrollment (India)   01/06/2023 
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="5" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   None 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

 

 

PORC (Postoperative residual curarisation) is a very common complication due to use of muscle relaxants with incidence ranging from 26% to 88% at various studies depending upon use of various definitions, criteria, study populations and type of muscle relaxants.

PORC can cause Postoperative pulmonary complications (PPC), increase length of hospital stay in postanesthesia care unit (PACU), risk of reintubation, aspiration.

Accleromyography is a commonly used neuromuscular monitoring (NMT) used as a quantitative tool for assessment of PORC, but its distressing to the patients in awake state. Hence diaphragm ultrasonography can be used to assess the PORC by measuring diaphragm thickening fraction [PORC is defined as diaphragm thickening fraction less than or equal to 0.36.

Neostigmine a commonly used reversal agent has many adverse effects such as airway obstruction, bradycardia, hyper salivation, broncho constriction, upper airway obstruction, dysphagia, nausea, vomiting.

Sugammadex, a novel reversal agent, causes full and rapid recovery even from deep neuromuscular blockade. Studies have shown that it reduces the incidence of PORC.

Most of the studies are based on effect Sugammadex on reversal of neuromuscular blockade by Rocuronium but very few studies have been done on effect of Sugammadex on Vecuronium induced neuromuscular blockade.

 

 

 
 
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