| CTRI Number |
CTRI/2025/09/094502 [Registered on: 10/09/2025] Trial Registered Prospectively |
| Last Modified On: |
10/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing two ways to dose sugammadex: which helps patient better in recovery from paralysis caused by muscle relaxants after general anesthesia? |
|
Scientific Title of Study
|
Comparison of effects of sugammadex in recommended dose and fixed dose on reversal of moderate neuromuscular blocking and recovery profile in patients under general anaesthesia. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
M P Manu Pradeep |
| Designation |
Post Graduate |
| Affiliation |
ESIC Medical College and Hospital |
| Address |
1st floor,no.12A,Yanaikatti maidanam , beemanagar,Trichy 620001
ESIC Medical college and Hospital,KK Nagar,Chennai 600078
Tiruchirappalli
TAMIL NADU
620001
India |
| Phone |
9487103238 |
| Fax |
|
| Email |
manu12pradeep@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Ilango Ganesan |
| Designation |
Professor |
| Affiliation |
ESIC Medical College and Hospital |
| Address |
Department of Anesthesia
B block
ESIC Medical college and Hospital,KK Nagar,Chennai 600078
Chennai
TAMIL NADU
600078
India |
| Phone |
9884149429 |
| Fax |
|
| Email |
gilang@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
M P Manu Pradeep |
| Designation |
Post Graduate |
| Affiliation |
ESIC Medical College and Hospital |
| Address |
1st floor,no.12A,Yanaikatti maidanam , beemanagar,Trichy 620001
ESIC Medical college and Hospital,KK Nagar,Chennai 600078
Tiruchirappalli
TAMIL NADU
620001
India |
| Phone |
9487103238 |
| Fax |
|
| Email |
manu12pradeep@gmail.com |
|
|
Source of Monetary or Material Support
|
| ESIC Medical College and Hospital, Ashok Pillar main road, KK Nagar, Chennai
Tamil Nadu-600078
India |
|
|
Primary Sponsor
|
| Name |
ESIC Medical College and Hospital |
| Address |
Ashok Pillar main road, KK Nagar,Chennai 600078 |
| 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 M P Manu Pradeep |
ESIC Medical College and Hospital |
Operation theatre,
Department of Anesthesiology, B-block, Ashok Pillar main road, KK Nagar, Chennai 600078
Chennai
TAMIL NADU |
9487103238
manu12pradeep@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: T885||Other complications of anesthesia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Inj. Sugammadex in 2mg/kg single dose by intravenous route. |
Inj.Sugammadex is given by single dose of 2mg/kg in 100ml normal saline slow intravenous route over 5 minutes then time taken to achieve a normalized TOF ratio of 0.9 is achieved in moderate neuromuscular blockade in patients under general anesthesia. |
| Intervention |
Inj. Sugammadex in fixed single dose of 200mg by intravenous route. |
Inj. Sugammadex is given at a fixed single dose of 200mg by slow intravenous infusion in 100ml normal saline over 5 minutes then time taken to achieve a normalized TOF ratio of 0.9 is achieved in moderate neuromuscular blockade in patients under general anesthesia. |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1.19-55 years of age of both sexes.
2.A BMI 20-30 kg/m2.
3.Patient belonging to ASA Physical status I and II.
4.Scheduled for elective surgery with expectant duration greater than 120 minutes under general anesthesia with written informed consent. |
|
| ExclusionCriteria |
| Details |
1.Patients with contraindication to sugammadex.
2.Patients who are pregnant.
3.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 to achieve a normalized TOF ratio 0.9 between recommended dose and fixed dose of suggamadex in reversing moderate neuromuscular blockade. |
Initial point - Administration of sugammadex on day of surgery after completion of surgical procedure.
Final point- Time at which a normalized TOF ratio of 0.9 is achieved on day of surgery after administration of sugammadex. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess time taken from sugammadex administration to fowllowing points (1)spontaneous respiration (2)response to verbal commands (3)motor control (4)extubation (5)recovery time (sugammadex to extubation)
|
On day of surgery after completion of surgical procedure. |
| To assess advere events & their management in both dosing strategies. |
On day of surgery after completion of surgical procedure |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 2 |
|
Date of First Enrollment (India)
|
23/09/2025 |
| 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="10"
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
|
This prospective, double blinded, randomized controlled trial compares the effects and recovery patterns of a fixed dose 200mg of sugammadex versus the recommended 2mg/kg dose for reversing moderate neuromuscular blockade in adults undergoing general anesthesia for elective surgeries expected to last over 120 minutes. The study aims to enroll 40 consented patients who are fulfilling inclusion criteria and assessed for exclusion criteria. Participants will be randomly allocated with the help of computer generated randomisation to either Group R (2mg/kg sugammadex) or Group F (200mg sugammadex), both administered as slow intravenous infusion in 100ml normal saline. Then time taken to achieve a normalized Train-of-Four (TOF) ratio greater than or equal to 0.9 in the two dosing strategies. Simultaneously the time from sugammadex administration to spontaneous respiration, response to verbal commands, adequate motor control, extubation and total recovery time is also measured alongside monitoring and managing adverse events such as bradycardia or anaphylaxis. Comprehensive intraoperative monitoring including ECG, NIBP, SpO2, EtCO2, Temperature, Heart Rate, Neuromuscular Function via TOF and bispectral index will be employed. All the data are recorded every 5 minutes intraoperatively and every 15 seconds after sugammadex administration. |