| 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
|
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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
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| Trial Acronym |
|
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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 |
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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 |
|
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Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, New Delhi, Ansari nagar, New Delhi- 110029 |
|
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Primary Sponsor
|
| Name |
AIIMS |
| Address |
Sri Aurobindo Marg, Ansari Nagar, Ansari Nagar East, New Delhi, Delhi 110029 |
| Type of Sponsor |
Research institution and hospital |
|
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Details of Secondary Sponsor
|
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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 |
|
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
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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 |
|
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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
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
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Blinding/Masking
|
Double Blind Double Dummy |
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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 |
|
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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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