| CTRI Number |
CTRI/2024/11/076207 [Registered on: 04/11/2024] Trial Registered Prospectively |
| Last Modified On: |
02/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of 2 reveral agents Sugammadex vs Neostigmine for reversal of general anesthhesia |
|
Scientific Title of Study
|
Comparison of Sugammadex vs Neostigmine for reversal of Vecuronium induced Neuromuscular Blockade A Randomised Controlled Study |
| 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 Chhaya Joshi |
| Designation |
Professor |
| Affiliation |
Professor |
| Address |
professor, dept of Anesthesia, Major ot complex, 1st floor
Department of Anesthesia , HSK hospital and research centre, SNMC Navanagar,
Bagalkot Karnataka
Bagalkot
KARNATAKA
587102
India |
| Phone |
9743320105 |
| Fax |
|
| Email |
drchhayajoshi1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Yogita Sunil Nepire |
| Designation |
1st year Postgraduate student Department of Anaesthesia |
| Affiliation |
1st year post graduate student |
| Address |
Department of Anesthesia , HSK hospital, SNMC Navanagar,
Bagalkot Karnataka
Department of Anesthesia , HSK hospital, SNMC Navanagar,
Bagalkot Karnataka
Bangalore
KARNATAKA
587102
India |
| Phone |
9591668859 |
| Fax |
|
| Email |
yogitanepire@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Yogita Sunil Nepire |
| Designation |
1st year Postgraduate student Department of Anaesthesia |
| Affiliation |
S. NIJALINGAPPA MEDICAL COLLEGE,HANAGAL SHRI KUMARESHWAR HOSPITAL AND RESEARCH CENTRE BAGALKOT. |
| Address |
S. NIJALINGAPPA MEDICAL COLLEGE,HANAGAL SHRI
KUMARESHWAR HOSPITAL AND RESEARCH CENTRE BAGALKOT.
Bagalkot
KARNATAKA
587102
India |
| Phone |
9591668859 |
| Fax |
|
| Email |
yogitanepire@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anesthesia , HSK hospital, SNMC Navanagar,
Bagalkot Karnataka,pin 587102 |
|
|
Primary Sponsor
|
| Name |
Department of anaesthesia |
| Address |
Department of Anesthesia , HSK hospital, SNMC Navanagar,
Bagalkot Karnataka |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| yogita sunil nepire |
snmc , bagalkot, hsk hospital and research centre |
major ot complex , 1st floor,Department of Anesthesia , HSK hospital and research centre, SNMC Navanagar,
Bagalkot Karnataka
Bagalkot
KARNATAKA |
09591668859
yogitanepire@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SNMC-INSTITUTIONAL ETHICS COMMITTEE ON HUMAN SUBJECTS RESEARCH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 8||Other Procedures, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Reversal of general anesthesia |
Comparison of Sugammadex vs Neostigmine for reversal of Vecuronium induced Neuromuscular Blockade,1 hour procedure |
| Comparator Agent |
Sugammadex vs Neostigmine |
Comparison of Sugammadex vs Neostigmine for reversal of Vecuronium induced Neuromuscular Blockade |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patient between 18-65 years of age.
Patient belonging to ASA physical status I-â…¢
|
|
| ExclusionCriteria |
| Details |
Anticipation of a difficult airway
Known or suspected neuromuscular disorders,
Significant renal dysfunction
Known or suspected family history of malignant hyperthermia
Allergies to narcotics, muscle relaxants
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Sugammadex provides significantly Faster Reversal Of Vecuronium Induced Neuromuscular Blockade |
1 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Sugammadex Provides better recovery of respiratory function following reversal of neuromuscular blockade of general anesthesia
2.Sugammadex as lower incidence of post op nausea and vomiting.
|
20 minutes |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
Final Enrollment numbers achieved (Total)= "120"
Final Enrollment numbers achieved (India)="120" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
08/11/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
: After surgery, reversal drugs such as Neostigmine are commonly administered to accelerate recovery of neuro muscular function, unfortunately these drugs will not provide fast restoration of neuro muscular function. Although neuromuscular blocking drugs are used extensively for facilitating surgical procedures and tracheal intubation during anaesthesia, concerns have been raised about the risks of post operative residual neuromuscular blockade, which may be associated with airway obstruction, pulmonary complications, hypoxia and increased mortality. Acetylcholine esterase inhibitor as Neostigmine is used for the reversal of non-depolarizing neuro muscular blockade ,but they carry risk of unwanted effects such as bradycardia, hypotension, bronchoconstriction, hypersalivation and nausea and vomiting. Anticholinergic drugs like atropine and glycopyrrolate are therefore co administered to counteract these adverse effects, but they may have their own side effects like tachycardia, blurred vision, sedation and mild confusion Rapid and complete reversal of neuromuscular blockade at the end of surgery is mandatory. Reducing residual neuromuscular block further decreases post op pulmonary complications. Choline esterase inhibitors are ineffective in reversing deep neuromuscular block and less effective when administered with inhalational anesthetics.
Post operative nausea and vomiting is one of the most common complication after general anesthesia that may cause increased morbidity and prolonged hospital stay Risk factors for PONV include: • Duration of anesthesia • Type of surgery • Post op analgesia with opioids • Patient related factors like age,gender,smoking • Previous history of PONV and motion sickness. Peak expiratory flow rate is surrogate marker for respiratory function. The use of neuromuscular drugs is frequently associated with post op residual neuromuscular blockade ,and increased post operative morbidity and mortality and greater frequency of critical respiratory events and prolonged hospital stay6 Because of these reasons there is need for better reversal drugs with improved side effect profile and number of studies that are conducted to compare efficacy of Sugammadex and Neostigmine are nominal ,hence we are planning to conduct this study in our institution |