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CTRI Number  CTRI/2024/11/076995 [Registered on: 19/11/2024] Trial Registered Prospectively
Last Modified On: 20/07/2026
Post Graduate Thesis  No 
Type of Trial  PMS 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Reversal of the effect of muscle paralytics with Sugammadex drug 
Scientific Title of Study   Efficacy aNd safety of Sugammadex on duration of mecHanical ventilAtion in patients who received Neuromuscular blockade in the ICU – A multicEntre randomized controlled trial (ENHANCE) 
Trial Acronym  ENHANCE 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Amarja Havaldar 
Designation  Associate Professor 
Affiliation  St Johns medical college 
Address  Department of Critical Care medicine St Johns Hospital Bangalore Bangalore KARNATAKA 560034 India

Bangalore
KARNATAKA
560034
India 
Phone  9036082112  
Fax    
Email  amarjahavaldar@rediffmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Amarja Havaldar 
Designation  Associate Professor 
Affiliation  St Johns medical college 
Address  Department of Critical Care medicine St Johns Hospital Bangalore Bangalore KARNATAKA 560034 India


KARNATAKA
560034
India 
Phone  9036082112  
Fax    
Email  amarjahavaldar@rediffmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Amarja Havaldar 
Designation  Associate Professor 
Affiliation  St Johns medical college 
Address  Department of Critical Care medicine St Johns Hospital Bangalore Bangalore KARNATAKA 560034 India


KARNATAKA
560034
India 
Phone  9036082112  
Fax    
Email  amarjahavaldar@rediffmail.com  
 
Source of Monetary or Material Support  
ICMR Ansari Nagar New Delhi, India Pincode 110029 
 
Primary Sponsor  
Name  ICMR 
Address  V Ramalingaswami Bhawan Box Number 4911 Ansari Nagar New Delhi 110029 India 
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
NIL   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Akshay Hiruyur Manjunatha swamy   JSS Medical college  Department of Critical Care Medicine
Mysore
KARNATAKA 		 9886222812

hmmakshay@gmail.com 
Dr Mahesh Padyana  Manipal Hospital Old Airport Road  Department of Critical care medicine
Bangalore
KARNATAKA 		 9448843933

padyana@gmail.com 
Dr Amarja Ashok Havaldar  St Johns medical college  Department of Critical Care medicine
Bangalore
KARNATAKA 		 9036082112

amarjahavaldar@rediffmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 4  
Name of Committee  Approval Status 
JSS Medical college  Approved 
Manipal Hospital Old Airport Road  Approved 
MS Ramaiah Medical college  Submittted/Under Review 
St Johns medical college, Insitutioal Ethics Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: T481||Poisoning by, adverse effect of and underdosing of skeletal muscle relaxants [neuromuscular blocking agents],  
 
Intervention / Comparator Agent
Modification(s)  
Type  Name  Details 
Comparator Agent  0.9 saline  In the control group equal volume of 0.9%saline will be administered.  
Intervention  Sugammadex  The study drug dose will be determined based on the depth of blockade. For deep blockade TOF 0/4 or 1/4- 4mg/kg For moderate blockade TOF 2/4 or more than 2/4, dose of 2mg/kg will be administered. With target TOF of 4/4and quantitative 0.9. Patients will be reassessed in 5 minutes and additional dose will be administered. Total 2 doses and maximum dose of 8mg/kg will be allowed. Patients will be reevaluated within 6 to 24 hrs for any persistent residual blockade and additional doses similar to described above will be administered. Ensuring total dose not exceeding 16mg/kg in 24 hrs. 
 
Inclusion Criteria
Modification(s)  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. Patients on invasive mechanical ventilation Received neuromuscular blocker infusion, rocuronium or vecuronium at least for 6hrs, or
received two or more doses of NMBA, excluding the dose received during intubation.
2. The decision of stopping of NMBA infusion/bolus has been taken by the clinical team and there is no longer requirement of NMB as per the evaluation.
 
 
ExclusionCriteria 
Details  Exclusion criteria
1.Pregnancy
2.Lactation
3.any known allergy to sugammadex.
4.Patients with decision of limitation of care based on shared decision-making process or severe multiorgan failure with chances of survival less than 48 hrs will be excluded.
5. Patients with neuromuscular weakness, diagnosed with critical illness neuromyopathy or any other preexisting neurological or neuromuscular illness that can interfere with assessment.
6. Patients transferred from another healthcare facility with neuromuscular weakness or without reliable details of previous medications.
7. Patients who have received invasive mechanical ventilation in the current admission and extubated and readmitted to ICU.
8. Patients who are on implantable devices such as pacemaker or implantable cardiac defibrillator
9.Patients with clinical signs of spontaneous recovery from NMB, sustained eye opening, head lift, limb movement, breathing CPAP Continuous positive airway pressure or Pressure Support-Positive end expiratory pressure PS-PEEP mode will be excluded or as determined by TOF 4/4 and Quantitative more than or equal to 0.9 will be excluded.
10.Patients with creatinine clearance less than 30ml per min and patient is not on renal replacement therapy 
 
Method of Generating Random Sequence
Modification(s)  		 Computer generated randomization 
Method of Concealment
Modification(s)  		 Centralized 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome
Modification(s)  
Outcome  TimePoints 
To compare the time to extubation between sugammadex and control group at day 14 after the administration of study drug/placebo.  Outcome will be assessed within 14 days after the administration of study drug/placebo 
 
Secondary Outcome
Modification(s)  
Outcome  TimePoints 
To compare the length of ICU stay in the sugammadex & the control group at day 28.
 		 Outcome will be assessed at day 28 after the randomization. 
To compare the incidence of ICU-acquired weakness in the sugammadex & control groups within 28 days.  Outcome will be assessed within 28 days after the randomization. 
To compare the number of ventilator-free days between the two groups at 28days.   Outcome will be assessed at day 28 after randomization. 
To compare the time taken for change of mode from assist-controlled to PS-PEEP/CPAP mode & extubation during 28 days  Outcome will be assessed within 28 days after randomization. 
To assess health economics parameters among the two groups includes cost benefit, cost utility & cost effectiveness analysis using incremental cost effectiveness ratio, ICER at day 28.  Outcome will assessed at day 28 after randomization. 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
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   Post Marketing Surveillance 
Date of First Enrollment (India)   30/07/2026 
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="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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
Modification(s)  

Neuromuscular blocking agents (NMBs) are routinely used in perioperative settings and in critically ill patients. These drugs facilitate intubation. NMBs are also used as a prolonged infusion in ventilator patient asynchrony, raised intracranial pressure, proning and severe acute respiratory distress syndrome. Neostigmine is the reversal agent routinely used in perioperative settings, but not used in an ICU settings, as the patient is allowed to naturally come out of the NMB action. Sugammadex is another reversal agent released in the year 2022. It is a gamma cyclodextrin that forms the complex with vecuronium or rocuronium and reduces the neuromuscular blocking agent available for binding to nicotinic receptors. Its advantages are rapid reversal and fewer adverse effects. The efficacy and safety is however not well studied in the ICU settings. Hence we propose a trial in the ICU to evaluate its effect on duration of ventilation and ICU stay.

The primary outcome is to compare the time to extubation between sugammadex and control group at day 14 after the administration of study drug/placebo.

The secondary outcomes are 

1.To compare the length of ICU stay in the sugammadex & the control group at day 28.

2.To compare the incidence of ICU acquired weakness in the sugammadex & control groups within 28 days.

3.To compare the number of ventilator free days between the two groups at 28days. 

4.To compare the time taken for change of mode from assist controlled to PS PEEP or CPAP mode & extubation during 28 days

5. To assess health economics parameters among the two groups includes cost benefit cost utility  & cost effectiveness analysis using incremental cost effectiveness ratio ICER at day 28.


This is a randomised parallel group placebo controlled  study. Study group will receive sugammadex and placebo group will receive 0.9% saline.

 
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