| CTRI Number |
CTRI/2024/05/067687 [Registered on: 20/05/2024] Trial Registered Prospectively |
| Last Modified On: |
10/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect Of Sugammadex On Anaesthesia Recovery In Elderly Patients Undergoing Urology Surgery |
|
Scientific Title of Study
|
Effect Of Sugammadex Vs Neostigmine On Bispectral Index In Elderly Patients Undergoing Urology Surgeries Under Steady State Total Intravenous Propofol Anesthesia: A Randomized Parallel Group Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Bhavesh Gupta |
| Designation |
Junior Resident Academic |
| Affiliation |
AIIMS Bhubaneswar |
| Address |
Department of Anesthesiology and Critical Care, OT Complex, 1st floor, Hospital Building, AIIMS Bhubaneswar
Khordha
ORISSA
751019
India |
| Phone |
9462691769 |
| Fax |
|
| Email |
bhaveshgupta002@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Nitasha Misra |
| Designation |
Associate Professor |
| Affiliation |
AIIMS Bhubaneswar |
| Address |
Room 7,5th Floor Hospital Building, Department of Anaesthesiology and Critical Care, AIIMS Bhubaneswar
Khordha
ORISSA
751019
India |
| Phone |
8373938016 |
| Fax |
|
| Email |
anaes_nitasha@aiimsbhubaneswar.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Nitasha Misra |
| Designation |
Associate Professor |
| Affiliation |
AIIMS Bhubaneswar |
| Address |
Room 7,5th Floor Hospital Building, Department of Anaesthesiology and Critical Care, AIIMS Bhubaneswar
Khordha
ORISSA
751019
India |
| Phone |
8373938016 |
| Fax |
|
| Email |
anaes_nitasha@aiimsbhubaneswar.edu.in |
|
|
Source of Monetary or Material Support
|
| Department of Anesthesiology and critical care, AIIMS,Bhubaneswar |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesiology and Critical Care AIIMS Bhubaneswar |
| Address |
Sijua Patrapada,Khorda, Odisha - 751019 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Bhavesh Gupta |
AIIMS Bhubaneswar |
Urology OT Complex, 2nd Floor
Khordha
ORISSA |
9462691769
bhaveshgupta002@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS Bhubaneswar 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 |
Group L |
Will receive Neostigmine (0.05mg/kg)+ Glycopyrrolate(0.02mg/kg).
Neostigmine inhibits the enzyme acetylcholinesterase and causes reversal from neuromuscular blockade. Glycopyrrolate is to prevent muscarinic side effects of neostigmine. |
| Intervention |
Group R |
Will receive Sugammadex 2 mg/kg.
Sugammadex is a modified gamma-cyclodextrin which forms very tight water soluble complexes at a 1:1 ratio with steroidal neuromuscular blocking drugs(eg, vecuronium) and which favors movement of neuromuscular blockade drug from the neuromuscular junction into the plasma, which quickly reverses neuromuscular blockade. |
|
|
Inclusion Criteria
|
| Age From |
65.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
American Society of Anaesthesiology Physical Status 1-3
Urology surgery
Requiring general anesthesia |
|
| ExclusionCriteria |
| Details |
Anticipated post op mechanical ventilation
Severe renal impairment (creatinine more than 2mg/dl)
History Of Uncontrolled thyroid disorder, MI
History of anaphylaxis/severe reaction to any administered drug
Consent refusal
Limitation to using BIS (History of central brain injury, pacemaker, Parkinson’s) |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the effect of sugammadex versus neostigmine on change of BIS value at end of surgery (time point t0 - just after skin closure) and at TOF count 4 with TOF ratio more than 0.7 (time point t1 - Primary end point) |
At time of surgery-
t0 - just after skin closure
t1 - TOF count 4 with TOF ratio more than 0.7 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Sedation score using Modified Observer Assessment of Alertness & Sedation (MOAAS) scale at timepoint t1.
Clinical signs of awakening at TOF 4. (eg, sucking, grimacing, moving & coughing on the tracheal tube)
Time to eye response.
Emergence delirium assessed by CAM scale at 1 hour & 24 hour post extubation.
Airway related complications within 30 mins post extubation. |
On day of surgery -
t0 - just after skin closure
t1 - TOF count 4 with TOF ratio more than 0.7
30 minutes post extubation
1 hour post extubation.
1 day after surgery -
24 hour post extubation.
|
|
|
Target Sample Size
|
Total Sample Size="46"
Sample Size from India="46"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
29/05/2024 |
| 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
|
There are no studies on the effect of neuromuscular blockade reversal on BIS and other processed EEG parameter in elderly patients . We hypothesise that the use of suggamadex as compared to neostigmine would lead to higher BIS and thereby better neurocognitive outcomes in elderly patients. |