| CTRI Number |
CTRI/2025/03/082137 [Registered on: 11/03/2025] Trial Registered Prospectively |
| Last Modified On: |
10/03/2025 |
| 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
|
Comparative study between Sugammadex and Neostigmine in reversing the neuromuscular blockade caused by Rocuronium under general anaesthesia |
|
Scientific Title of Study
|
Comparison of Sugammadex versus Neostigmine for the reversal of Rocuronium induced neuromuscular blockade under general anaesthesia: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 Kapadam Pavan Sai Kumar Reddy |
| Designation |
Post Graduate |
| Affiliation |
Chamarajanagar Institute of Medical Sciences |
| Address |
Department of Anaesthesiology, Chamarajanagar Institute of Medical Sciences Chamarajanagar Yadapura , CHAMARAJANAGAR (District),KARNATAKA 571313 India
Chamarajanagar
KARNATAKA
571313
India |
| Phone |
8919973398 |
| Fax |
|
| Email |
pavansaikumarreddy@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Darshan M S |
| Designation |
HOD, Department of Anaesthesiology |
| Affiliation |
Chamarajanagar Institute of Medical Sciences |
| Address |
Department of Anaesthesiology, Chamarajanagar Institute of Medical Sciences, Chamarajanagar
Chamarajanagar
KARNATAKA
571313
India |
| Phone |
9741376797 |
| Fax |
|
| Email |
darshanms_jss@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kapadam Pavan Sai Kumar Reddy |
| Designation |
Post Graduate |
| Affiliation |
Chamarajanagar Institute of Medical Sciences |
| Address |
Department of Anaesthesiology Chamarajanagar Institute of Medical Sciences Chamarajanagar, Yadapura , CHAMARAJANAGAR(district) KARNATAKA, 571313,India
Chamarajanagar
KARNATAKA
571313
India |
| Phone |
8919973398 |
| Fax |
|
| Email |
pavansaikumarreddy@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology Chamarajanagar Institute of Medical Sciences Chamarajanagar, Yadapura , CHAMARAJANAGAR(district), KARNATAKA, 571313, India |
|
|
Primary Sponsor
|
| Name |
Chamarajanagar Institute of Medical Sciences |
| Address |
Department of Anaesthesiology Chamarajanagar Institute of Medical Sciences Chamarajanagar Yadapura , CHAMARAJANAGAR(district) KARNATAKA, 571313, India |
| Type of Sponsor |
Government 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 |
| Dr Kapadam Pavan Sai Kumar Reddy |
Chamarajanagar Institute of Medical University |
Department of Anaesthesiology, Yadapura,Chamarajanagar,CHAMARAJANAGAR(district) KARNATAKA, 571313, India
Chamarajanagar
KARNATAKA |
8919973398
pavansaikumarreddy@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Inj.Neostigmine |
50mcg/kg of Inj.Neostigmine + Inj.Glycopyrolate(10mcg/kg) given for reversal of Rocuronium(0.6mg/kg)induced neuromuscular blockade and time taken for reversal is noted. |
| Intervention |
Inj.Sugammadex |
2mg/kg of Inj.Sugammadex given for reversal of Rocuronium(0.6mg/kg)induced neuromuscular blockade and time taken for reversal is noted.Patient will be monitered for 2 hours for any hemodynamic changes. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1)Patient willing to participate with written informed consent.
2)Patients belonging to ASA grade I and 2 of either sex.
3)Patient with age group between 18 to 70 years posted for elective surgeries under General Anaesthesia |
|
| ExclusionCriteria |
| Details |
1)Known allergy to any of study drugs
2)Pregnancy and Lactation
3)Patients with history of high dose steroid intake
4)Patients with known Cardiac disorders/Respiratory illnesses/Endocrine disorders
5)Patients with known history of Renal dysfunction/Hepatic dysfunction
6)Patients who are suspected to have Neuromuscular disorders |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the time taken for neuromuscular recovery between Sugammadex reversal and Neostigmine reversal for Rocuronium induced neuromuscular blockade as indicated by TOF monitoring |
Time taken for the reversal till TOF ratio of 0.9 is achieved. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study hemodynamic changes between two groups of patients. |
Intraoperatively and After extubation patient was monitered for any hemodynamic variability |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
21/03/2025 |
| 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="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
|
1) General Anaesthesia relies on neuromuscular blockade to improve airway management and surgical conditions. However, residual neuromuscular blockade has been linked to an increased risk of pulmonary complications after surgery. The introduction of quantitative neuromuscular monitoring devices in the 1970s rendered subjective clinical parameters for monitoring neuromuscular blockade nearly become obsolete. 2)Deep neuromuscular blockade can enhance surgical conditions during major abdominal procedures and reduce insufflation pressures in laparoscopic surgeries. However, it is important to note that deep neuromuscular blockade has been associated with potential complications such as prolonged postoperative muscle paralysis, residual neuromuscular blockade, hypoxemia, and atelectasis. 3)Non-depolarizing neuromuscular blockers like Rocuronium are frequently used to relax muscles during surgery and to aid ventilate the lungs in emergency and elective cases. It is one of the several non-depolarizing neuromuscular blockers that are employed, but it stands out for being reversible and fast-acting. 4)Traditionally, acetylcholinesterase inhibitors were commonly used to reverse the effects of nondepolarizing neuromuscular blocking agents. However, these inhibitors were not effective enough in reversing deep blockade and can cause residual neuromuscular blockade with some undesirable effects. A new reversal agent called Sugammadex has been developed, which works by encapsulating and reversing the effects of Rocuronium. This study is planned to assess the efficacy and safety of Sugammadex to reverse the effect of Rocuronium induced neuromuscular blockade in comparison with standard Neostigmine reversal for the same. |