| CTRI Number |
CTRI/2024/11/076937 [Registered on: 18/11/2024] Trial Registered Prospectively |
| Last Modified On: |
17/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Sugammadex versus Neostigmine - the time to reversal of Rocuronium block. |
|
Scientific Title of Study
|
Sugammadex versus Neostigmine - time to reversal of Rocuronium block in patients undergoing surgery under General Anaesthesia: A Randomized 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 |
Preethi R |
| Designation |
Junior Resident |
| Affiliation |
All India institute of Medical Sciences, Bibinagar |
| Address |
Department of Anaesthesiology
AIIMS BIBINAGAR
Rangapur Village
Bibinagar Mandal
Hyderabad Metropolitan Region
Telangana
Hyderabad
TELANGANA
508126
India |
| Phone |
9791546087 |
| Fax |
|
| Email |
ihteerp31@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Preethi R |
| Designation |
Junior Resident |
| Affiliation |
All India institute of Medical Sciences, Bibinagar |
| Address |
Department of Anaesthesiology
AIIMS Bibinagar
Rangapur village
Bibinagar Mandal
Hyderabad Metropolitan Region
Telangana
Hyderabad
TELANGANA
508126
India |
| Phone |
9791546087 |
| Fax |
|
| Email |
ihteerp31@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Preethi R |
| Designation |
Junior Resident |
| Affiliation |
All India institute of Medical Sciences, Bibinagar |
| Address |
Department of Anaesthesiology
AIIMS Bibinagar
Rangapur village
Bibinagar Mandal
Hyderabad Metropolitan Region
Telangana
Hyderabad
TELANGANA
508126
India |
| Phone |
9791546087 |
| Fax |
|
| Email |
ihteerp31@gmail.com |
|
|
Source of Monetary or Material Support
|
| Preethi R
AIIMS Bibinagar
Rangapur Village
Bibinagar Mandal
Hyderabad Metropolitan region
Telangana -508126 |
|
|
Primary Sponsor
|
| Name |
Preethi R |
| Address |
AIIMS Bibinagar
Rangapur Village
Bibinagar Mandal
Hyderabad Metropolitan region
Telangana -508126 |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Preethi R |
AIIMS BIBINAGAR |
Department of Anaesthesiology
Rangapur Village
Bibinagar Mandal
Hyderabad Metropolitan region
Telangana -508126
Hyderabad
TELANGANA |
9791546087
ihteerp31@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS BIBINAGAR IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C509||Malignant neoplasm of breast of unspecified site, (2) ICD-10 Condition: C73||Malignant neoplasm of thyroid gland, (3) ICD-10 Condition: H958||Other intraoperative and postprocedural complications and disorders of the ear and mastoid process, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Neostigmine |
Neostigmine is a reversal agent works by inhibiting cholinesterase and increasing acetylcholine levels to compete with nondepolarising neuromuscular blocking agent. |
| Intervention |
Sugammadex |
It is a modified gamma - cyclodextrin , a newer agent that selectively reverse steroidal non depolarising neuromuscular blocking drugs rocuronium and vecuronium. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA PS 1 and 2
Elective surgeries under general anaesthesia ( thyroid , ENT and breast surgeries)
|
|
| ExclusionCriteria |
| Details |
Emergency Surgery
Pregnant patients
Significant renal dysfunction, severe hepatic dysfunction, cardiac disease
Anticipated difficult airway |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Time taken from administering reversal agent (sugammadex or Neostigmine) to tracheal extubation |
At baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Compare the change in handgrip and Peak expiratory flow rate (PEFR) at 15min , 30 min and 60 min after reversal with Sugammadex or Neostigmine among patients undergoing general anaesthesia |
15min, 30 min and 60 min |
| Incidence of postoperative desaturation, upper airway obstruction, need for reintubation upto 1hour in PACU , 24 hours in ICU after reversal of Rocuronium induced neuromuscular blockade with Sugammadex and Neostigmine |
24 hours |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="20" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
17/12/2024 |
| Date of Study Completion (India) |
06/02/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="10" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
This study aims to identify time to reversal of rocuronium block in Neostigmine vs sugammadex (a newer reversal agent ) in Indian Population in patients undergoing surgery under General anesthesia. |