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CTRI Number  CTRI/2023/02/049969 [Registered on: 22/02/2023] Trial Registered Prospectively
Last Modified On: 08/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect of two drugs on improvement of lung function after operative fixation of cervical spine: A Prospective, Double Blinded, Randomised Control Trial  
Scientific Title of Study   Effect of Sugammadex versus Neostigmine Reversal on Lung Aeration Score after Operative Fixation of Cervical Spine: A Prospective, Double Blinded, 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  Sumit Roy Chowdhury 
Designation  Senior Resident 
Affiliation  Department of Neuroanesthesiology and critical care, AIIMS, NEW DELHI 
Address  Room 13, 6th floor, Department of Neuroanesthesiology and Critical Care, CNC, AIIMS

New Delhi
DELHI
110029
India 
Phone  9874621132  
Fax    
Email  sumitroychowdhury94@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Ashish Bindra 
Designation  Professor 
Affiliation  Department of Neuroanesthesiology and Critical Care, AIIMS, NEW DELHI 
Address  Room 13, 6th floor, Department of Neuroanesthesiology and Critical Care, CNC, AIIMS

New Delhi
DELHI
110029
India 
Phone  8826417127  
Fax    
Email  drashishbindra@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Sumit Roy Chowdhury 
Designation  SENIOR RESIDENT 
Affiliation  Department of Neuroanesthesiology and Critical Care, AIIMS, NEW DELHI 
Address  Department of Neuroanesthesiology and Critical Care, ROOM 13, 6TH FLOOR, CNC, AIIMS, NEW DELHI

New Delhi
DELHI
110029
India 
Phone  9874621132  
Fax    
Email  sumitroychowdhury94@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences, New Delhi, Ansari nagar, New Delhi- 110029 
 
Primary Sponsor  
Name  AIIMS 
Address  Sri Aurobindo Marg, Ansari Nagar, Ansari Nagar East, New Delhi, Delhi 110029 
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 Sumit Roy Chowdhury  AIIMS  Department of Neuroanesthesiology and critical care, AIIMS, NEW DELHI Address : Room 13, 6th floor, Department of Neuroanesthesiology and Critical Care, CNC, AIIMS New Delhi DELHI 110029 India
New Delhi
DELHI 
9874621132

sumitroychowdhury94@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC  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  70 ug/kg Neostigmine with Glycopyrrolate 01 mg to 0.2 mg for every 1 mg Neostigmine. The dose of neostigmine will be rounded to the closest 0.1 mg. Drug will be given at the end of the surgery as a single dose 
Intervention  Sugammadex  2mg/kg of actual body weight rounded to the closest 10 mg, at the end of the surgery as a single dose 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. ASA I-III physical status patients
2. Who have consented to participate in the study
3. Age- 18-65 years
 
 
ExclusionCriteria 
Details  1. Chronic kidney disease
2. Chronic liver disease
3. Allergy to study drugs
4. Patients with previously diagnosed lung pathologies- COPD, Asthma, pneumonia or any other known lung pathology.
5. Obese patients
6. Patients with previous thoracic surgery
7. Chest wall deformity
8. Recent surgery under GA in last 30 days
9. Patients with associated chest injury
10. Traumatic brain injury
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
To compare the lung aeration score at 24 hours post operatively.  Just before the start of the surgery and 24 hours after the end of the surgery 
 
Secondary Outcome  
Outcome  TimePoints 
1. Length of ICU stay
2. Length of hospital stay
3. 30 day mortality
4. Incidence of tracheostomy during hospital stay
5. POPC till day 7
6. Extubation on table
7. Duration of mechanical ventilation
8. Change in motor power from baseline (at admission) motor power at discharge
 
30 days 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
Final Enrollment numbers achieved (Total)= "75"
Final Enrollment numbers achieved (India)="75" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/03/2023 
Date of Study Completion (India) 31/03/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details   not published 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Post operative pulmonary complications (POPC) are one of the leading contributors of prolonged hospital stay. The incidence of respiratory complications in patients with cervical spine injury (CSI) is well reported and the pathophysiology behind these complications after CSI is complex and multifactorial. Surgical decompression is often recommended for both traumatic and degenerative cervical spine pathologies currently. The altered lung mechanics during corrective surgery further contributes to the development of pulmonary morbidities. Residual neuromuscular blockade after surgery is one common culprit behind the development of pulmonary complications subsequently. Sugammadex, a gamma-cyclodextrin compound has shown promising results in reducing the incidence of POPC in different subgroup of patients. It has been postulated that, due to the unique mechanism, sugammadex is able to reverse the effect of steroidal non-depolarizing neuromuscular blocking agents more efficiently as compared to traditional neostigmine reversal. There is no available study where sugammadex was used in CSI patients. 

Lung ultrasound is an easy and effective modality to detect several underlying respiratory pathologies. Depending on the number of B-lines found in specific areas during sonography, a quantitative scoring system have been postulated which have been widely used in various settings for prediction of weaning from mechanical ventilation, for ventilatory strategy intraoperatively as well as in ARDS patients, for perioperative assessment of the lung aeration etc. Lung aeration score has been successfully used to predict POPCs after major abdominal surgeries.  In this prospective, double-blind randomized control trial, we hypothesize that Sugammadex reversal will result in a lower i.e., better lung aeration score 24 hrs after surgery as compared to the neostigmine group. We have, therefore, planned this study to compare the effect of sugammadex to neostigmine on the lung aeration score after surgical fixation of CSI.

 
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